Red Blood Cells Transfusion. Clinical Trial
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.
| Status | Not yet recruiting |
| Enrollment | 10 |
| Est. completion date | |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Tel-Aviv Sourasky Medical Center | Tel-Aviv |
| Lead Sponsor | Collaborator |
|---|---|
| Tel-Aviv Sourasky Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Primary | Mortality and morbidity | A composite end point that includes all cause mortality and morbidity occurring till 6 weeks post surgery. | 6 weeks post surgery | No |
| Secondary | Admission to ICU | 6 weeks post surgery | No | |
| Secondary | Hospital lengths of stay | 6 weeks post surgery | No | |
| Secondary | RBC transfusions | The investigators will also evaluate the incidence of RBC transfusions and the number of units transfused. | Hospitaliztion | No |