NCT03326323

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Bleeding Reduction

Interventions

Type	Name	Description
PROCEDURE	Acute Normovolemic Hemodilution	Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery.

Timeline

• Start date: 2018-03-19
• Primary completion: 2019-09-17
• Completion: 2019-10-17
• First posted: 2017-10-31
• Last updated: 2020-01-13
• Results posted: 2020-01-13

Locations

1 site across 1 country: United States