Clinical Trials Logo
NCT number NCT00038454
Study type Interventional
Source Hemosol
Contact
Status Suspended
Phase Phase 2/Phase 3

Clinical Trial Summary

To evaluate the efficacy of Hemolink™ in combination with Intraoperative Autologous Donation (IAD) versus control (IAD alone) in facilitating avoidance of allogeneic RBC transfusion during and following primary CABG surgery


Clinical Trial Description

All subjects who consent to take part in the protocol and who meet the inclusion/exclusion criteria will undergo the IAD harvest following a post-induction IAD harvest calculation. IAD blood will be collected into citrate-phosphate-dextrose-adenine 1 (CPDA-1) blood bags. All subjects will receive a volume of Hespan® equal to the volume of their IAD harvest (to a maximum of 1 liter) performed as a result of the harvest calculation (0–1200 mL inclusive). Additional volume replacement required owing to IAD >1000mL will be performed with crystalloid, as required. Subjects will be randomized into one of two treatment arms (Hemolink™ arm or control arm) upon meeting a transfusion trigger for the first time while on CPB. Randomization will be administered centrally. Subjects will be transfused upon reaching predetermined transfusion triggers, reflecting a decrease in hemoglobin concentration and/or oxygenation:


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Completed NCT02502812 - Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects Phase 1
Completed NCT02147626 - Heart Health 4 Moms N/A
Recruiting NCT02998918 - Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL Phase 2
Recruiting NCT02835287 - Diabetes Complication Control in Community Clinics (D4C) Trial N/A
Recruiting NCT02868710 - Individual Variability to Aerobic Exercise Training N/A
Recruiting NCT03095261 - Incentives in Cardiac Rehabilitation N/A
Recruiting NCT02589769 - Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons N/A
Not yet recruiting NCT02578355 - National Plaque Registry and Database N/A
Recruiting NCT02640859 - Investigation of Metabolic Risk in Korean Adults N/A
Recruiting NCT02272946 - Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk Phase 2
Recruiting NCT02885792 - Coronary Artery Disease in Patients Suffering From Schizophrenia N/A
Active, not recruiting NCT02652975 - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium N/A
Active, not recruiting NCT02657382 - Mental Stress Ischemia: Biofeedback Study N/A
Recruiting NCT02081066 - Identification of CETP as a Marker of Atherosclerosis N/A
Recruiting NCT02265250 - Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment N/A
Active, not recruiting NCT02428634 - The Program SI! for Cardiovascular Health Promotion at Elementary School N/A
Active, not recruiting NCT02600338 - Meta-analyses of the Effect of Legumes on Blood Pressure N/A
Active, not recruiting NCT02325531 - SPREAD-NET: PRactices Enabling Adapting and Disseminating in the Safety NET N/A
Completed NCT02208180 - Heart Healthy Lenoir: Return of Results Study N/A
Completed NCT03054779 - Canola Oil Multi-center Intervention Trial II N/A