Biomarker and Thrombogenicity Assessment in Cardiopulmonary Bypass Surgery Utilizing Acute Normovolemic Hemodilution

Bleeding Reduction Clinical Trial

— TARGET-ANH  

Official title:

A Pilot Study Involving the Changes in the Markers of Coagulation During Cardiopulmonary Bypass Surgery Utilizing Acute Normovolemic Hemodilution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326323
• Other study ID #: 172809
• Status: Completed
• Start date: March 19, 2018
• Est. completion date: October 17, 2019

Study information

• Verified date: December 2019
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 17, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bleeding Reduction
• Hemorrhage

Intervention

Procedure:
• Acute Normovolemic Hemodilution
Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery.

Locations

Country	Name	City	State
United States	Inova Heart and Vascular Institute	Falls Church	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Inova Health Care Services	Instrumentation Laboratory

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery in Platelet Function Post ANH	Time it takes (hours) for platelet function to recover post-ANH to pre-procedure levels as measured by platelet aggregation.	Baseline through 24 hours post ANH procedure
Secondary	Recovery in Mean Clot Firmness Post ANH	Time it takes for Mean Clot Firmness (MCF) to return normal levels post-ANH as measured by ROTEM	Baseline through 24 hours post ANH procedure