Trial Outcomes & Findings for Biomarker and Thrombogenicity Assessment in Cardiopulmonary Bypass Surgery Utilizing Acute Normovolemic Hemodilution (NCT NCT03326323)

Last Updated: 2020-01-13

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

43 participants

Primary outcome timeframe

Baseline through 24 hours post ANH procedure

Results posted on

2020-01-13

Participant milestones
Measure	Patients Undergoing ANH During CABG 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 Study STARTED	43
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	Patients Undergoing ANH During CABG 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 Study Unable to receive ANH protocol	3

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

Baseline characteristics by cohort
Measure	Patients Undergoing ANH During CABG n=43 Participants 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.
Age, Continuous	66 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants

Timeframe: 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.

Outcome measures
Measure	Patients Undergoing ANH During CABG n=40 Participants 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.
Recovery in Platelet Function Post ANH	2 hours Standard Deviation 30

Timeframe: 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

Outcome measures
Measure	Patients Undergoing ANH During CABG n=40 Participants 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.
Recovery in Mean Clot Firmness Post ANH	18 hours Standard Deviation 6

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Inova Heart and Vascular Institute

Phone: 703-776-4138