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

Purpose

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.

Condition	Intervention
Red Blood Cells Transfusion.	Other: Red blood cells transfusion

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:

Functional outcome [ Time Frame: 6 weeks post surgery ] [ Designated as safety issue: No ]
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 [ Time Frame: 6 weeks post surgery ] [ Designated as safety issue: No ]
A composite end point that includes all cause mortality and morbidity occurring till 6 weeks post surgery.

Secondary Outcome Measures:

Admission to ICU [ Time Frame: 6 weeks post surgery ] [ Designated as safety issue: No ]
Hospital lengths of stay [ Time Frame: 6 weeks post surgery ] [ Designated as safety issue: No ]
RBC transfusions [ Time Frame: Hospitaliztion ] [ Designated as safety issue: No ]
The investigators will also evaluate the incidence of RBC transfusions and the number of units transfused.

Estimated Enrollment:	10
Study Start Date:	January 2012
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491308

Contacts

Contact: Idit Matot, Prof

972-3-6974758 ext 4758

iditm@tasmc.health.gov.il

Locations

Israel
Tel-Aviv Sourasky Medical Center	Not yet recruiting
Tel-Aviv, Israel, 64239
Contact: Idit Matot, Prof 972-3-6974758 ext 4758 iditm@tasmc.health.gov.il

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

More Information

No publications provided

Responsible Party:	Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:	NCT01491308 History of Changes
Other Study ID Numbers:	TASMAC-11-IM-0449-11-CTIL
Study First Received:	December 8, 2011
Last Updated:	December 12, 2011
Health Authority:	Israel: Ministry of Health

ClinicalTrials.gov processed this record on May 19, 2013