CATAS-HF: Compression Wraps as Adjuvant Therapy in Management of Acute Systolic Heart Failure

• Sponsor: Henry Ford Health System (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04095416
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.2
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

There will be two populations in this study: control group, and intervention group. These groups will undergo propensity matching to account for confounders and minimize selection bias. 120 patients will be enrolled, 60 to each population. The objective of this study is: assess the utility of lower extremity compression wraps as adjuvant therapy in inpatient management of acute systolic heart failure

The control group will consist of patients admitted to I5 Cardiology for management of acute systolic heart failure with intravenous diuresis and standard medical therapy, meeting inclusion criteria. Information will be gathered through observational prospective data analysis from Epic EMR, and will include daily diuretic type and dose required, daily urine output, daily creatinine, total days of admission, daily and pre-discharge weight, admission BNP, and pre-discharge BNP.

The intervention group will consist of patients admitted to I5 Cardiology meeting inclusion criteria and being managed with standard medical therapy. This group will receive additional therapy using bilateral lower extremity compression wraps applied by nursing staff per pre-set protocol, and will receive education on the use of compression wraps. Patients will be instructed to wear the compression wraps for the entirety of the time they are undergoing intravenous diuresis, with pauses in care as needed for hygiene and symptom relief purposes. During the time of compression wrap application, the following data will be collected: urine output, daily weights, daily creatinine, daily and total dose and type of intravenous diuretic used. Prior to discharge, a BNP will be obtained.

Endpoints (including percentage of weight reduction, total urine output achieved with diuresis, total dose requirement and type of intravenous diuresis, total days of intravenous diuresis, days to discharge, discharge BNP, and percent reduction from admission BNP) will then be compared to assess the utility of adding lower extremity compression wraps to inpatient management of acute systolic heart failure.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; With Decompensation	Device: ACE compression wrap	N/A

Detailed Description

There will be two populations in this study: control group, and intervention group. 120 patients will be enrolled, 60 to group, randomized in 1:1 fashion. The control group will consist of patients admitted to I5 Cardiology for management of acute systolic heart failure with intravenous diuresis and standard medical therapy, meeting inclusion criteria. Information will be gathered through observational prospective data analysis from Epic EMR, and will include daily diuretic type and dose required, daily urine output, daily creatinine, total days of admission, daily and pre-discharge weight, admission BNP, and pre-discharge BNP. The intervention group will consist of patients admitted to I5 Cardiology meeting inclusion criteria and being managed with standard medical therapy. This group will receive additional therapy using bilateral lower extremity compression wraps applied by nursing staff per pre-set protocol, and will receive education on the use of compression wraps. Patients will be instructed to wear the compression wraps for the entirety of the time they are undergoing intravenous diuresis, with pauses in care as needed for hygiene and symptom relief purposes. During the time of compression wrap application, the following data will be collected: urine output, daily weights, daily creatinine, daily and total dose and type of intravenous diuretic used. Prior to discharge, a BNP will be obtained. Endpoints (including percentage of weight reduction, total urine output achieved with diuresis, total dose requirement and type of intravenous diuresis, total days of intravenous diuresis, days to discharge, discharge BNP, and percent reduction from admission BNP) will then be compared to assess the utility of adding lower extremity compression wraps to inpatient management of acute systolic heart failure.

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two arms, one interventional group and one control. Interventional group receives compression wraps and standard medical care, control group only receives standard medical careTwo arms, one interventional group and one control. Interventional group receives compression wraps and standard medical care, control group only receives standard medical care
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Compression Wraps as Adjuvant Therapy in the Management of Acute Systolic Heart Failure (CATAS-HF)
• Actual Study Start Date: Aug 15, 2019
• Actual Primary Completion Date: Mar 2, 2020
• Actual Study Completion Date: Jan 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Bilateral lower extremity ACE compression wraps in addition to standard medical care	Device: ACE compression wrap; Bilateral lower extremity ACE compression wraps
No Intervention: Control Standard medical care

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Readmission Within 30-days [30 days from hospital discharge]

   Assess rate of 30-day readmission of patients enrolled in study

2. Total Length of Hospital Stay [From admission to hospital discharge, up to 30 days]

   Assess the length of hospitalization, controlling for variables

3. Days on IV Diuretic Therapy [From admission to hospital discharge, up to 30 days]

   Assess the number of days from start of IV diuresis to transition to PO diuresis

Secondary Outcome Measures

1. Average Percentage of BNP Change [From admission to hospital discharge, up to 30 days]

   Assess the average percent of BNP reduction of intervention vs control groups

2. Average Pre-discharge BNP [From admission to hospital discharge, up to 30 days]

   Assess the average pre-discharge BNP of intervention vs control groups

3. Net Intake/Output of Fluids During Hospitalization [From admission to hospital discharge, up to 30 days]

   Assess the net intake/output across the hospitalization of intervention vs control groups, obtained through nursing documentation of fluid intake and output recorded daily during the hospitalization

4. IV Diuretic Infusion Used [From admission to hospital discharge, up to 30 days]

   Assess the use of IV diuretic in intervention vs control groups

5. Average Percentage of Weight Change During Hospitalization [From admission to hospital discharge, up to 30 days]

   Assess the average percent of weight reduction of intervention vs control groups

6. AKI During Hospitalization [From admission to hospital discharge, up to 30 days]

   Development of acute kidney injury during hospitalization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age greater than 18 and less than 85 years of age

• admitted to I5 with Acute Systolic Heart Failure with an ejection fraction of less than 50% as determined by echocardiogram within 6 months

• requiring inpatient management with intravenous diuresis.

• diagnosis of acute systolic heart failure, of any underlying etiology

• at least 2+ pitting edema (or documented lower extremity pitting edema of at least moderate or significant severity) on primary assessment.

Exclusion Criteria:

• cannot tolerate IV diuresis

• who cannot wear or tolerate lower extremity compression stockings or wraps

• ESRD

• peripheral neuropathy

• ejection fraction greater than 50% as evaluated by echocardiogram within 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henry Ford Hospital	Detroit	Michigan	United States	48202

Sponsors and Collaborators

• Henry Ford Health System

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 1, 2020
• Informed Consent Form - Aug 1, 2019

More Information

Publications

None provided.

• Responsible Party: Joseph Miller, MD, Emergency Medicine, Internal Medicine Physician, Henry Ford Health System
• ClinicalTrials.gov Identifier: NCT04095416
• Other Study ID Numbers: CATASHFtrial2019
• First Posted: Sep 19, 2019
• Last Update Posted: Mar 29, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Joseph Miller, MD, Emergency Medicine, Internal Medicine Physician, Henry Ford Health System: Compression wraps; heart failure; systolic; edema; wrap
• Additional relevant MeSH terms: Heart Failure; Heart Failure, Systolic; Systolic Murmurs

Study Results

Participant Flow

Pre-assignment Detail	Enrollment terminated early due to COVID-19 pandemic

Arm/Group Title	Intervention	Control
Arm/Group Description	Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Standard medical care
Period Title: Overall Study
STARTED	13	19
COMPLETED	10	19
NOT COMPLETED	3	0

Baseline Characteristics

Arm/Group Title	Intervention	Control	Total
Arm/Group Description	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care	Total of all reporting groups
Overall Participants	10	19	29
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	4 40%	8 42.1%	12 41.4%
>=65 years	6 60%	11 57.9%	17 58.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63 (16)	64 (12)	64 (13)
Sex: Female, Male (Count of Participants)
Female	3 30%	4 21.1%	7 24.1%
Male	7 70%	15 78.9%	22 75.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	6 60%	12 63.2%	18 62.1%
White	4 40%	7 36.8%	11 37.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Admission weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	98.3 (30.9)	91.2 (21.3)	93.7 (24.7)
Admission BNP (pg/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pg/mL]	2279 (1613)	1997 (1296)	2095 (1391)
Ejection fraction, baseline (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]	32 (10)	26 (9)	28 (10)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Readmission Within 30-days
Description	Assess rate of 30-day readmission of patients enrolled in study
Time Frame	30 days from hospital discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care
Measure Participants	10	19
Count of Participants [Participants]	2 20%	5 26.3%

2. Primary Outcome

Title	Total Length of Hospital Stay
Description	Assess the length of hospitalization, controlling for variables
Time Frame	From admission to hospital discharge, up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care
Measure Participants	10	19
Mean (Standard Deviation) [days]	4.6 (2.6)	7.4 (3.9)

3. Primary Outcome

Title	Days on IV Diuretic Therapy
Description	Assess the number of days from start of IV diuresis to transition to PO diuresis
Time Frame	From admission to hospital discharge, up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care
Measure Participants	10	19
Mean (Standard Deviation) [days]	4.2 (3.1)	5.0 (1.8)

4. Secondary Outcome

Title	Average Percentage of BNP Change
Description	Assess the average percent of BNP reduction of intervention vs control groups
Time Frame	From admission to hospital discharge, up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care
Measure Participants	10	19
Mean (Standard Deviation) [% change]	-38.5 (22.8)	-38.2 (57.6)

5. Secondary Outcome

Title	Average Pre-discharge BNP
Description	Assess the average pre-discharge BNP of intervention vs control groups
Time Frame	From admission to hospital discharge, up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care
Measure Participants	10	19
Mean (Standard Deviation) [pg/mL]	1404 (1441)	1238 (896)

6. Secondary Outcome

Title	Net Intake/Output of Fluids During Hospitalization
Description	Assess the net intake/output across the hospitalization of intervention vs control groups, obtained through nursing documentation of fluid intake and output recorded daily during the hospitalization
Time Frame	From admission to hospital discharge, up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care
Measure Participants	10	19
Mean (Standard Deviation) [L]	-8.13 (8.05)	-7.08 (6.21)

7. Secondary Outcome

Title	IV Diuretic Infusion Used
Description	Assess the use of IV diuretic in intervention vs control groups
Time Frame	From admission to hospital discharge, up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care
Measure Participants	10	19
Count of Participants [Participants]	0 0%	7 36.8%

8. Secondary Outcome

Title	Average Percentage of Weight Change During Hospitalization
Description	Assess the average percent of weight reduction of intervention vs control groups
Time Frame	From admission to hospital discharge, up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care
Measure Participants	10	19
Mean (Standard Deviation) [% change]	-7.2 (6.1)	-5.7 (5.2)

9. Secondary Outcome

Title	AKI During Hospitalization
Description	Development of acute kidney injury during hospitalization
Time Frame	From admission to hospital discharge, up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care
Measure Participants	10	19
Count of Participants [Participants]	1 10%	13 68.4%

Adverse Events

Time Frame	Up to 30 days after discharge
Adverse Event Reporting Description	Does not differ from clinicaltrials.gov definition
Arm/Group Title	Intervention		Control
Arm/Group Description	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team		Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care
All Cause Mortality
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/19 (0%)
Serious Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.