Safety and Effectiveness of Two Blood Transfusion Strategies in Surgical Patients With Cardiovascular Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

2,016

Participants

Timeline

Start Date

July 31, 2003

Primary Completion Date

May 31, 2009

Study Completion Date

May 31, 2009

Conditions
AnemiaHematologic DiseasesCardiovascular DiseasesHeart DiseasesMyocardial InfarctionThromboembolismPneumoniaCerebrovascular Accident
Interventions
BIOLOGICAL

Liberal (10 g/dL) Transfusion Strategy

This transfusion strategy will maintains postoperative Hgb levels above 10 g/dL. This threshold strategy will use enough red blood cell units to maintain Hgb levels at or above 10 g/dL through hospital discharge or up to 30 days after randomization.

BIOLOGICAL

Restrictive (Symptomatic) Transfusion Strategy

Transfusion is withheld until the patient develops symptoms from anemia (i.e., chest pain or ECG changes thought to be ischemic, congestive heart failure, unexplained tachycardia or hypotension unresponsive to fluids) or until the hemoglobin level falls below 8 g/dL. Transfusion is permitted, but is not mandatory, if the hemoglobin level falls below 8 g/dL.

Trial Locations (1)

08903

University Medicine & Dentistry of NJ, New Brunswick

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Rutgers, The State University of New Jersey

OTHER

NCT00071032 - Safety and Effectiveness of Two Blood Transfusion Strategies in Surgical Patients With Cardiovascular Disease | Biotech Hunter | Biotech Hunter