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

Not Applicable

• Conditions: Red Blood Cells Transfusion.
• Interventions: Other: Red blood cells transfusion

• Registration Number: NCT01491308
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-12
• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2011-12-12
• Last Update Submitted: 2011-12-12
• Study First Posted: 2011-12-13
• Last Update Posted: 2011-12-13
• Study Start: 2012-01
• Primary Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restrictive	Red blood cells transfusion	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.
Liberal	Red blood cells transfusion	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.

Primary Outcome Measures

Name	Time	Method
Functional outcome	6 weeks post surgery	Functional outcome during hospital stay and at 6 weeks as defined by the Modified Rivermead Mobility Index attached below (a functional index that measures different functionalities of the patient. This index is daily measured by the physiotherapist's group
Mortality and morbidity	6 weeks post surgery	A composite end point that includes all cause mortality and morbidity occurring till 6 weeks post surgery.

Secondary Outcome Measures

Name	Time	Method
Admission to ICU	6 weeks post surgery
Hospital lengths of stay	6 weeks post surgery
RBC transfusions	Hospitaliztion	The investigators will also evaluate the incidence of RBC transfusions and the number of units transfused.

Trial Locations

Locations (1)

Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel-Aviv, Israel