Restrictive Versus Liberal Red Cell Transfusion Strategy in Orthopedic-Oncology Patients Undergoing Surgery - a Randomized Controlled Study

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Red Blood Cells Transfusion.

Treatments: Other: Red blood cells transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01491308

TASMAC-11-IM-0449-11-CTIL

Details and patient eligibility

About

The rationale for perioperative red blood cell (RBC) transfusion is based on the observation that anemia is an independent risk factor for morbidity and mortality after cardiac operations. However, transfusions have been associated with high rates of morbidity and mortality in critically ill patients, and some recent studies have shown worse outcomes, including increased occurrence of renal failure and infection, as well as respiratory, cardiac, and neurological complications, in transfused compared with non transfused patients after cardiac surgery. On the basis of past clinical observations, some authors have suggested that hematocrit should be maintained at around 30% and hemoglobin concentration at 10 g/dL. Recently, however, this hemoglobin threshold has been reconsidered because of recognized risks associated with transfusion and greater appreciation of the importance of individual physiological responses to anemia. In a comparative trial of 428 patients undergoing elective coronary artery bypass graft(CABG) surgery, Bracey et al reported that reducing the hemoglobin trigger to 8 g/dL did not adversely affect patient outcomes and resulted in lower costs. An important multicenter Canadian Study by Hebert et al that included a large number of critically ill patients revealed that A restrictive strategy of red-cell transfusion (hemoglobin concentration maintained between 7.0and 9.0g/dL) is at least as effective as and possibly superior to a liberal transfusion (hemoglobin concentration between 10 and 12 g/dL) strategy in critically ill patients, with the possible exception of patients with acute myocardial infarction and unstable angina, in terms of reducing organ dysfunction and mortality.

The investigators would like to determine whether a restrictive strategy of red-cell transfusion and a liberal strategy produce equivalent results in orthopedic-oncology patients undergoing surgery.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consecutive ASA I-III patients, with preoperative hemoglobin 12 gr% or less scheduled for major orthopedic-oncology surgery (one that is expected to carry moderate to severe blood loss) at Tel Aviv Sourasky Medical Center will be included in the study.

Exclusion criteria

• Patients will be excluded for any of the following reasons:
• an age of less than 18 years;
• inability to receive blood products;
• pregnancy;
• emergency procedures;
• hepatic dysfunction (total bilirubin value higher than 1.5 mg/d);
• end-stage renal disease (receiving chronic dialysis therapy);
• acute coronary syndrome, active heart or lung disease and refusal to consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Restrictive

Active Comparator group

Description:

Hemoglobin concentrations will be maintained in the range of 7.5 to 9.0 g per deciliter, with a transfusion given when the hemoglobin concentration is below 7.5 g per deciliter.

Treatment:

Other: Red blood cells transfusion

Liberal

Active Comparator group

Description:

Hemoglobin concentrations will be maintained in the range of 10.0 to 12.0 g per deciliter, with a transfusion given when the hemoglobin concentration is below 10.0 g per deciliter.

Treatment:

Other: Red blood cells transfusion