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

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.

Study Overview

• Status: Unknown
• Conditions: Red Blood Cells Transfusion.
• Intervention / Treatment: Other: Red blood cells transfusion

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Idit Matot, Prof; Phone Number: 4758 972-3-6974758; Email: iditm@tasmc.health.gov.il

Study Locations

• Israel
  • Tel-Aviv, Israel, 64239
    • Tel-Aviv Sourasky Medical Center
    • Contact: Idit Matot, Prof; Phone Number: 4758 972-3-6974758; Email: iditm@tasmc.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Restrictive; 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.	Other: Red blood cells transfusion; This transfusion policy holds to any time from the start of surgery until discharge. The physicians caring for the patient will be instructed to administer transfusion, one unit at a time, and to measure the patient's hemoglobin concentration after each unit is transfused. In both groups, no further units will be given if the goal hemoglobin was obtained (7.5 g per deciliter for the restrictive arm and 10.0 g per deciliter for the liberal one). All other management decisions are left to the discretion of the patients' physicians. Attending physicians can administer RBC transfusions outside the rules of the protocol (i.e more than 1 unit at a time, without determining pre-transfusion hemoglobin) if severe acute bleeding occurs or other forms of circulatory shock.
Active Comparator: Liberal; 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.	Other: Red blood cells transfusion; This transfusion policy holds to any time from the start of surgery until discharge. The physicians caring for the patient will be instructed to administer transfusion, one unit at a time, and to measure the patient's hemoglobin concentration after each unit is transfused. In both groups, no further units will be given if the goal hemoglobin was obtained (7.5 g per deciliter for the restrictive arm and 10.0 g per deciliter for the liberal one). All other management decisions are left to the discretion of the patients' physicians. Attending physicians can administer RBC transfusions outside the rules of the protocol (i.e more than 1 unit at a time, without determining pre-transfusion hemoglobin) if severe acute bleeding occurs or other forms of circulatory shock.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome	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	6 weeks post surgery
Mortality and morbidity	A composite end point that includes all cause mortality and morbidity occurring till 6 weeks post surgery.	6 weeks post surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: December 8, 2011
• First Submitted That Met QC Criteria: December 12, 2011
• First Posted (Estimate): December 13, 2011

Study Record Updates

• Last Update Posted (Estimate): December 13, 2011
• Last Update Submitted That Met QC Criteria: December 12, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: TASMAC-11-IM-0449-11-CTIL