The Fibrin Pad CV Phase III Study

• Sponsor: Ethicon, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02040428
• Collaborator: (none)
• Enrollment: 156
• Locations: 24
• Arms: 2
• Actual Duration (Months): 20
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Biological: EVARREST™ Fibrin Sealant Patch; Biological: Topical hemostat	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 156 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Single-blinded, Randomized, Controlled, Comparative Phase III Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EVARREST™ Fibrin Sealant Patch EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).	Biological: EVARREST™ Fibrin Sealant Patch
Active Comparator: Topical hemostat Equine collagen with Human Fibrinogen and Human Thrombin	Biological: Topical hemostat

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application. [Intraoperative, 3 minutes following treatment application]

   Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure

Secondary Outcome Measures

1. Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application [Intraoperative, 6 minutes following treatment application]

   The number of subjects achieving hemostatic success at 6 minutes following treatment application with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.

2. Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application [Intraoperative, 10 minutes following treatment application]

   The number of subjects achieving hemostatic success at 10 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.

3. Number of Participants With Re-bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment [Intra-operative, prior initiation of final chest wall closure.]

   The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had intra-operative re-bleeding requiring treatment at the TBS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass. Subjects in Japan between ≥18 and <20 years of age will require consent by the subject's legal representative

• Subjects must be willing to participate in the study and provide written informed consent.

• Presence of an appropriate Target Bleeding Site (TBS) along the anastomotic suture line, involving a synthetic aortic graft, as identified intra-operatively by the investigator;

Exclusion Criteria:

• Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;

• Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 60 day follow up period after surgery.

• Female subjects who are pregnant or nursing.

• TBS is from a large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of EVARREST™ Fibrin Sealant Patch to blood flow and/or pressure during absorption of the product;

• TBS with major arterial bleeding requiring suture or mechanical ligation;

• TBS involves an expanded polytetrafluoroethylene (ePTFE) graft

• TBS within an actively infected field;

• Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;

• Subjects with any intra-operative findings identified by the investigator that may preclude conduct of the study procedure;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Investigation Site #15	Atlanta	Georgia	United States	30342
2	Clinical Investigation Site #14	Indianapolis	Indiana	United States	46290
3	Clinical Investigation Site #16	Baltimore	Maryland	United States	21201
4	Clinical Investigation Site #21	Bethesda	Maryland	United States	20814
5	Clinical Investigation Site #17	Saint Louis	Missouri	United States	63110
6	Clinical Investigation Site #10	Paterson	New Jersey	United States	07503
7	Clinical Investigation Site #12	New York	New York	United States	10016
8	Clinical Investigation Site #20	Philadelphia	Pennsylvania	United States	19102
9	Clinical Investigation Site #18	Houston	Texas	United States	77030
10	Clinical Investigation Site #72	Camperdown	New South Wales	Australia	2050
11	Clinical Investigation Site #73	Sydney	New South Wales	Australia	2010
12	Clinical Investigation Site #71	Brisbane	Queensland	Australia	4000
13	Clinical Investigation Site #74	Bedford Park	South Australia	Australia	5042
14	Clinical Investigation Site #70	Melbourne	Victoria	Australia	3050
15	Clinical Investigation Site #40	Gent		Belgium	9000
16	Clinical Investigation Site #82	Kanagawa	Isehara-shi	Japan
17	Clinical Investigation Site #81	Saitama	Saitama-shi	Japan
18	Clinical Investigation Site #80	Osaka	Suita-shi	Japan
19	Clinical Investigation Site #33	Bristol	England	United Kingdom	BS2 8HW
20	Clinical Investigation Site #35	Cottingham	England	United Kingdom	HU16 5JQ
21	Clinical Investigation Site #34	Manchester	England	United Kingdom	M13 9WL
22	Clinical Investigation Site #32	Aberdeen	Scotland	United Kingdom	AB25 2ZN
23	Clinical Investigation Site #31	Clydebank	Scotland	United Kingdom	G81 4DY
24	Clinical Investigation Site #30	Edinburgh	Scotland	United Kingdom	EH16 4SA

Sponsors and Collaborators

• Ethicon, Inc.

Investigators

• Study Director: Richard Kocharian, MD, PhD, Ethicon, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ethicon, Inc.
• ClinicalTrials.gov Identifier: NCT02040428
• Other Study ID Numbers: BIOS-13-004; 2013-003464-31
• First Posted: Jan 20, 2014
• Last Update Posted: Aug 15, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ethicon, Inc.: Cardiovascular Diseases; Fibrin Sealant; Hemostatics; Coagulants
• Additional relevant MeSH terms: Cardiovascular Diseases; Fibrin Tissue Adhesive

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from January 13, 2014 through September 23, 2015 at hospitals and medical centers throughout the United States, United Kingdom, Belgium, Japan and Australia.
Pre-assignment Detail	One subject was randomized to EVARREST, but instead received TachoSil; and analyzed in EVARREST ITT set and in TachoSil group for Safety set. Therefore, Safety set consists of 75 subjects in EVARREST arm and 81 subjects in TachoSil arm, while the ITT set consists of 76 subjects in EVARREST arm and 80 subjects in TachoSil arm.

Arm/Group Title	EVARREST Fibrin Sealant Patch	TachoSil
Arm/Group Description	EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.	TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
Period Title: Overall Study
STARTED	75	81
Intent to Treat (Randomized Subjects)	76	80
COMPLETED	70	77
NOT COMPLETED	5	4

Baseline Characteristics

Arm/Group Title	EVARREST Fibrin Sealant Patch	TachoSil	Total
Arm/Group Description	EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.	TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.	Total of all reporting groups
Overall Participants	75	81	156
Age, Customized (Number) [Number]
<=18 years	0 0%	0 0%	0 0%
Between 18 < 50 years	14 18.7%	12 14.8%	26 16.7%
50 < 65 years	21 28%	32 39.5%	53 34%
65 < 75	22 29.3%	25 30.9%	47 30.1%
>= 75	18 24%	12 14.8%	30 19.2%
Sex: Female, Male (Count of Participants)
Female	19 25.3%	20 24.7%	39 25%
Male	56 74.7%	61 75.3%	117 75%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 8%	4 4.9%	10 6.4%
Not Hispanic or Latino	68 90.7%	76 93.8%	144 92.3%
Unknown or Not Reported	1 1.3%	1 1.2%	2 1.3%
Race/Ethnicity, Customized (Number) [Number]
White/Caucasian	62 82.7%	66 81.5%	128 82.1%
Black or African American	2 2.7%	2 2.5%	4 2.6%
Native Hawaiian or Other Pacific Islander	0 0%	1 1.2%	1 0.6%
Asian	10 13.3%	11 13.6%	21 13.5%
Other	1 1.3%	1 1.2%	2 1.3%
BMI Category (Number) [Number]
Underweight	2 2.7%	0 0%	2 1.3%
Normal	20 26.7%	18 22.2%	38 24.4%
Overweight	31 41.3%	32 39.5%	63 40.4%
Obese	20 26.7%	30 37%	50 32.1%
Morbidly obese	2 2.7%	1 1.2%	3 1.9%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.
Description	Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure
Time Frame	Intraoperative, 3 minutes following treatment application

Outcome Measure Data

Analysis Population Description

The primary endpoint analysis was based on the Intent to Treat (ITT) analysis set, consisting of all randomized subjects.

Arm/Group Title	EVARREST Fibrin Sealant Patch	TachoSil
Arm/Group Description	EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.	TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
Measure Participants	76	80
Number [Participants]	57 76%	36 44.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EVARREST Fibrin Sealant Patch, TachoSil
	Comments	Superiority
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Adaptive group sequential design
	Comments	Whitehead method for triangular test

2. Secondary Outcome

Title	Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application
Description	The number of subjects achieving hemostatic success at 6 minutes following treatment application with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.
Time Frame	Intraoperative, 6 minutes following treatment application

Outcome Measure Data

Analysis Population Description

The secondary endpoint analyses were based on the Intent to Treat (ITT) analysis set.

Arm/Group Title	EVARREST Fibrin Sealant Patch	TachoSil
Arm/Group Description	EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.	TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
Measure Participants	76	80
Number [Participants]	59 78.7%	45 55.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EVARREST Fibrin Sealant Patch, TachoSil
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0046
	Comments
	Method	Chi-squared
	Comments

3. Secondary Outcome

Title	Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application
Description	The number of subjects achieving hemostatic success at 10 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.
Time Frame	Intraoperative, 10 minutes following treatment application

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EVARREST Fibrin Sealant Patch	TachoSil
Arm/Group Description	EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.	TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
Measure Participants	76	80
Number [Participants]	64 85.3%	56 69.1%

4. Secondary Outcome

Title	Number of Participants With Re-bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment
Description	The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had intra-operative re-bleeding requiring treatment at the TBS
Time Frame	Intra-operative, prior initiation of final chest wall closure.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EVARREST Fibrin Sealant Patch	TachoSil
Arm/Group Description	EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.	TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
Measure Participants	76	80
Number [Participants]	5 6.7%	4 4.9%

Adverse Events

Time Frame	From surgical procedure through the 60 day follow-up (+/-14 days)
Arm/Group Title	EVARREST Fibrin Sealant Patch		TachoSil
Arm/Group Description	EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.		TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
All Cause Mortality
	EVARREST Fibrin Sealant Patch		TachoSil
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	EVARREST Fibrin Sealant Patch		TachoSil
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	31/75 (41.3%)		34/81 (42%)
Blood and lymphatic system disorders
Anemia	1/75 (1.3%)		1/81 (1.2%)
Coagulopathy	0/75 (0%)		1/81 (1.2%)
Haemolytic Anaemia	0/75 (0%)		1/81 (1.2%)
Thrombocytopenia	1/75 (1.3%)		0/81 (0%)
Cardiac disorders
Acute myocardial infarction	1/75 (1.3%)		0/81 (0%)
Atrial fibrillation	7/75 (9.3%)		8/81 (9.9%)
Atrial flutter	0/75 (0%)		1/81 (1.2%)
Atrioventricular block complete	2/75 (2.7%)		1/81 (1.2%)
Cardiac arrest	2/75 (2.7%)		0/81 (0%)
Cardiac failure congestive	0/75 (0%)		1/81 (1.2%)
Cardiac tamponade	1/75 (1.3%)		2/81 (2.5%)
Cardiogenic shock	3/75 (4%)		0/81 (0%)
Myocardial depression	0/75 (0%)		1/81 (1.2%)
Pericardial effusion	1/75 (1.3%)		3/81 (3.7%)
Right ventricular failure	1/75 (1.3%)		0/81 (0%)
Ventricular extrasystoles	0/75 (0%)		1/81 (1.2%)
Gastrointestinal disorders
Intestinal ischaemia	0/75 (0%)		1/81 (1.2%)
General disorders
Chest pain	1/75 (1.3%)		0/81 (0%)
Multi-organ failure	2/75 (2.7%)		1/81 (1.2%)
Pyrexia	0/75 (0%)		1/81 (1.2%)
Systemic inflammatory response syndrome	1/75 (1.3%)		0/81 (0%)
Infections and infestations
Appendicitis	1/75 (1.3%)		0/81 (0%)
Bacteraemia	0/75 (0%)		1/81 (1.2%)
Bronchopneumonia	0/75 (0%)		1/81 (1.2%)
Cellulitis	1/75 (1.3%)		0/81 (0%)
Pneumonia	2/75 (2.7%)		3/81 (3.7%)
Postoperative wound infection	1/75 (1.3%)		0/81 (0%)
Respiratory tract infection	1/75 (1.3%)		0/81 (0%)
Sepsis	1/75 (1.3%)		0/81 (0%)
Urinary tract infection	0/75 (0%)		1/81 (1.2%)
Wound infection	1/75 (1.3%)		0/81 (0%)
Injury, poisoning and procedural complications
Anastomotic haemorrhage	4/75 (5.3%)		0/81 (0%)
Arterial injury	0/75 (0%)		1/81 (1.2%)
Cardiac procedure complication	0/75 (0%)		1/81 (1.2%)
Post procedural haemorrhage	3/75 (4%)		4/81 (4.9%)
Postoperative thoracic procedure complication	1/75 (1.3%)		0/81 (0%)
Procedural complication	0/75 (0%)		1/81 (1.2%)
Subdural haemorrhage	1/75 (1.3%)		0/81 (0%)
Investigations
Anticoagulation drug level above therapeutic	1/75 (1.3%)		0/81 (0%)
International normalised ratio fluctuation	0/75 (0%)		1/81 (1.2%)
Metabolism and nutrition disorders
Hyperglycaemia	1/75 (1.3%)		0/81 (0%)
Hyperkalaemia	1/75 (1.3%)		0/81 (0%)
Hyponatraemia	1/75 (1.3%)		0/81 (0%)
Nervous system disorders
Brain injury	0/75 (0%)		1/81 (1.2%)
Cerebrovascular accident	1/75 (1.3%)		2/81 (2.5%)
Convulsion	1/75 (1.3%)		0/81 (0%)
Grand mal convulsion	0/75 (0%)		1/81 (1.2%)
Hypoxic-ischaemic encephalopathy	1/75 (1.3%)		0/81 (0%)
Presyncope	1/75 (1.3%)		0/81 (0%)
Psychiatric disorders
Delirium	0/75 (0%)		1/81 (1.2%)
Renal and urinary disorders
Renal failure	1/75 (1.3%)		2/81 (2.5%)
Renal failure acute	1/75 (1.3%)		2/81 (2.5%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/75 (1.3%)		0/81 (0%)
Chronic obstructive pulmonary disease	1/75 (1.3%)		0/81 (0%)
Haemothorax	0/75 (0%)		1/81 (1.2%)
Pleural effusion	6/75 (8%)		7/81 (8.6%)
Pneumothorax	1/75 (1.3%)	1	0/81 (0%)	0
Pulmonary embolism	1/75 (1.3%)		0/81 (0%)
Respiratory failure	3/75 (4%)		3/81 (3.7%)
Skin and subcutaneous tissue disorders
Subcutaneous emphysema	2/75 (2.7%)		0/81 (0%)
Vascular disorders
Hypertension	0/75 (0%)		1/81 (1.2%)
Jugular vein thrombosis	1/75 (1.3%)		0/81 (0%)
Venous thrombosis limb	1/75 (1.3%)		0/81 (0%)
Other (Not Including Serious) Adverse Events
	EVARREST Fibrin Sealant Patch		TachoSil
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	73/75 (97.3%)		80/81 (98.8%)
Blood and lymphatic system disorders
Anaemia	18/75 (24%)		21/81 (25.9%)
Thrombocytopenia	7/75 (9.3%)		7/81 (8.6%)
Cardiac disorders
Atrial fibrillation	34/75 (45.3%)		29/81 (35.8%)
Cardiac failure congestive	4/75 (5.3%)		1/81 (1.2%)
Pericardial effusion	1/75 (1.3%)		8/81 (9.9%)
Tachycardia	3/75 (4%)		5/81 (6.2%)
Gastrointestinal disorders
Constipation	15/75 (20%)		15/81 (18.5%)
Diarrhoea	8/75 (10.7%)		2/81 (2.5%)
Nausea	19/75 (25.3%)		20/81 (24.7%)
Vomiting	5/75 (6.7%)		7/75 (9.3%)
General disorders
Chest pain	5/75 (6.7%)		3/81 (3.7%)
Oedema peripheral	5/75 (6.7%)		13/81 (16%)
Pain	9/75 (12%)		11/81 (13.6%)
Pyrexia	11/75 (14.7%)		10/81 (12.3%)
Infections and infestations
Pneumonia	5/75 (6.7%)		4/81 (4.9%)
Urinary tract infection	9/75 (12%)		5/81 (6.2%)
Wound infection	4/75 (5.3%)		4/81 (4.9%)
Injury, poisoning and procedural complications
Anastomotic haemorrhage	4/75 (5.3%)		0/81 (0%)
Post procedural haemorrhage	5/75 (6.7%)		5/81 (6.2%)
Procedural pain	9/75 (12%)		5/81 (6.2%)
Wound complication	3/75 (4%)		9/81 (11.1%)
Metabolism and nutrition disorders
Fluid overload	12/75 (16%)		11/81 (13.6%)
Hyperglycaemia	11/75 (14.7%)		11/81 (13.6%)
Hyperkalaemia	6/75 (8%)		2/81 (2.5%)
Hypocalcaemia	6/75 (8%)		4/81 (4.9%)
Hypokalaemia	7/75 (9.3%)		7/81 (8.6%)
Hypomagnesaemia	3/75 (4%)		5/81 (6.2%)
Hyponatraemia	5/75 (6.7%)		1/81 (1.2%)
Hypophosphataemia	6/75 (8%)		3/81 (3.7%)
Nervous system disorders
Dizziness	5/75 (6.7%)		3/81 (3.7%)
Psychiatric disorders
Anxiety	2/75 (2.7%)		5/81 (6.2%)
Confusional state	3/75 (4%)		6/81 (7.4%)
Delirium	3/75 (4%)		7/81 (8.6%)
Insomnia	1/75 (1.3%)		9/81 (11.1%)
Renal and urinary disorders
Renal failure acute	3/75 (4%)		5/81 (6.2%)
Respiratory, thoracic and mediastinal disorders
Atelectasis	6/75 (8%)		12/81 (14.8%)
Cough	4/75 (5.3%)		6/81 (7.4%)
Dyspnoea	7/75 (9.3%)		5/81 (6.2%)
Pleural effusion	24/75 (32%)		22/81 (27.2%)
Pneumothorax	8/75 (10.7%)		5/81 (6.2%)
Pulmonary oedema	5/75 (6.7%)		4/81 (4.9%)
Vascular disorders
Hypertension	4/75 (5.3%)		9/81 (11.1%)
Hypotension	15/75 (20%)		18/81 (22.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.