TARGET-ANH: Biomarker and Thrombogenicity Assessment in Cardiopulmonary Bypass Surgery Utilizing Acute Normovolemic Hemodilution

• Sponsor: Inova Health Care Services (Other)
• Overall Status: Completed
• CT.gov ID: NCT03326323
• Collaborator: Instrumentation Laboratory (Industry)
• Enrollment: 43
• Location: 1
• Actual Duration (Months): 19
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

This study will help enhance current understanding of the impact of Acute Normovolemic Hemodilution (ANH) administration on transfusion requirements post cardiac surgery, the effect of this procedure on coagulation, and platelet hemostasis, and the amount of chest tube drainage 24 hours post coronary artery bypass graft surgery (CABG) surgery.

Condition or Disease	Intervention/Treatment	Phase
Bleeding Reduction	Procedure: Acute Normovolemic Hemodilution

Detailed Description

Acute Normovolemic Hemodilution (ANH) involves the removal of the patients own blood immediately at the induction of anesthesia and replacement of this blood intraoperatively with an equivalent volume of crystalloid or colloid solution in order to dissuade the loss of red blood cell mass, the mechanism of action is dilution of the blood, hematocrit reduction, and reduction of the anticoagulant components of the blood associated with bleeding during cardiopulmonary bypass graft surgery. The collected blood is isolated from the negative effects of the cardiopulmonary bypass machine.. The collected blood is then stored in anticoagulant treated blood bags in the cardiovascular operating room and re-infused into the patient in reverse order of collection at the commencement of surgery, leaving the most cell rich blood to be re-infused into the patient last. This study will evaluate the effect in patients with and without ANH utilization on; hemostatic markers, chest tube drainage 24 hours post CABG, and need for allergenic blood transfusion. Positive effects on the hemostatic markers of anticoagulation and platelets, reduced chest tube drainage at 24 hours post CABG, and reduced number of transfused red blood cells will indicate a positive correlation with ANH utilization during isolated on pump CABG surgery.

The benefits of ANH utilization in blood conservation will benefit patients by reducing their exposure to allogenic blood transfusion with its myriad side effects.

Study Design

• Study Type: Observational
• Actual Enrollment: 43 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Pilot Study Involving the Changes in the Markers of Coagulation During Cardiopulmonary Bypass Surgery Utilizing Acute Normovolemic Hemodilution
• Actual Study Start Date: Mar 19, 2018
• Actual Primary Completion Date: Sep 17, 2019
• Actual Study Completion Date: Oct 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Patients undergoing ANH during CABG Patients undergoing Acute Normovolemic Hemodilution during CABG surgery.	Procedure: Acute Normovolemic Hemodilution; Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery.

Outcome Measures

Primary Outcome Measures

1. Recovery in Platelet Function Post ANH [Baseline through 24 hours post ANH procedure]

   Time it takes (hours) for platelet function to recover post-ANH to pre-procedure levels as measured by platelet aggregation.

Secondary Outcome Measures

1. Recovery in Mean Clot Firmness Post ANH [Baseline through 24 hours post ANH procedure]

   Time it takes for Mean Clot Firmness (MCF) to return normal levels post-ANH as measured by ROTEM

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. . Subject is 18-85 years old.

2. . Subject is hemodynamically stable

3. . The subject is able to read and has signed and dated the informed consent document including Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization permitting release of personal health information as approved by the investigator's Institutional Review Board (IRB).

Exclusion Criteria:

1. . Hematocrit <30 at baseline

2. . Insufficient (Low) on pump hematocrit of < 21%

3. . Patient is hemodynamically unstable

4. . Patient requiring an emergency procedure

5. . Left main coronary artery stenosis with evidence of hemodynamic instability (e.g.. hypotension, ST segment elevations on electrocardiogram)

6. . Aortic valve stenosis with evidence of hemodynamic instability (e.g.. hypotension, ST segment elevations on electrocardiogram)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inova Heart and Vascular Institute	Falls Church	Virginia	United States	22042

Sponsors and Collaborators

• Inova Health Care Services
• Instrumentation Laboratory

Investigators

• Principal Investigator: Eric L Sarin, MD, Inova Heart and Vascular Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 12, 2019

More Information

Publications

None provided.

• Responsible Party: Inova Health Care Services
• ClinicalTrials.gov Identifier: NCT03326323
• Other Study ID Numbers: 172809
• First Posted: Oct 31, 2017
• Last Update Posted: Jan 13, 2020
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Inova Health Care Services: acute normovolemic hemodilution

Study Results

Participant Flow

Arm/Group Title	Patients Undergoing ANH During CABG
Arm/Group Description	Patients undergoing Acute Normovolemic Hemodilution during CABG surgery. Acute Normovolemic Hemodilution: Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery.
Period Title: Overall Study
STARTED	43
COMPLETED	40
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Patients Undergoing ANH During CABG
Arm/Group Description	Patients undergoing Acute Normovolemic Hemodilution during CABG surgery. Acute Normovolemic Hemodilution: Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery.
Overall Participants	43
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66 (10)
Sex: Female, Male (Count of Participants)
Female	5 11.6%
Male	38 88.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	6 14%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 7%
White	30 69.8%
More than one race	2 4.7%
Unknown or Not Reported	2 4.7%
Region of Enrollment (participants) [Number]
United States	43 100%

Outcome Measures

1. Primary Outcome

Title	Recovery in Platelet Function Post ANH
Description	Time it takes (hours) for platelet function to recover post-ANH to pre-procedure levels as measured by platelet aggregation.
Time Frame	Baseline through 24 hours post ANH procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Undergoing ANH During CABG
Arm/Group Description	Patients undergoing Acute Normovolemic Hemodilution during CABG surgery. Acute Normovolemic Hemodilution: Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery.
Measure Participants	40
Mean (Standard Deviation) [hours]	2 (30)

2. Secondary Outcome

Title	Recovery in Mean Clot Firmness Post ANH
Description	Time it takes for Mean Clot Firmness (MCF) to return normal levels post-ANH as measured by ROTEM
Time Frame	Baseline through 24 hours post ANH procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Undergoing ANH During CABG
Arm/Group Description	Patients undergoing Acute Normovolemic Hemodilution during CABG surgery. Acute Normovolemic Hemodilution: Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery.
Measure Participants	40
Mean (Standard Deviation) [hours]	18 (6)

Adverse Events

Time Frame	in-hospital and 30 days
Arm/Group Title	Patients Undergoing ANH During CABG
Arm/Group Description	Patients undergoing Acute Normovolemic Hemodilution during CABG surgery. Acute Normovolemic Hemodilution: Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery.
All Cause Mortality
	Patients Undergoing ANH During CABG
	Affected / at Risk (%)	# Events
Total	0/40 (0%)
Serious Adverse Events
	Patients Undergoing ANH During CABG
	Affected / at Risk (%)	# Events
Total	0/40 (0%)
Other (Not Including Serious) Adverse Events
	Patients Undergoing ANH During CABG
	Affected / at Risk (%)	# Events
Total	0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.