Blood Management in Orthopedic Surgery

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Aim: to investigate whether the use of several transfusion alternatives (erythropoietin, the cell-saver or postoperative drainage and reinfusion systems) in patients undergoing elective total knee or hip replacement surgery can lead to allogeneic red blood cell (RBC) saving if a restrictive transfusion policy is used.

Study design: a prospective, double randomized, open, multicenter study in which patients are stratified according to their preoperative hemoglobin(Hb) level: stratum I= Hb between 6,1 and 8,2 mmol/l. These patients are first randomized for Erythropoetin (Epo) or no Epo.

Stratum II= Hb of 6,1 and lower or 8,2 mmol/l and higher, are not eligible for Epo and thus not randomized. Patients in both strata will be randomized for three modalities: a cell saver (CS)(to wash, filter and reinfuse autologous shed blood) which is used intra- and postoperatively or a postoperative autologous reinfusion drainage system (D) only (to filter and reinfuse autologous shed blood) or a restrictive transfusion trigger only (controls).

Inclusion criteria: All orthopedic patients of 18 years and older being considered for a primary or revision total knee- (TKR) or total hip replacement (THR).

Outcome measures:

Primary outcome: number of allogeneic red blood cell (RBC) transfusions.

Secondary outcome: transfusion reactions, rehabilitation time, length of hospital stay (days), peri- and post-operative complications during hospitalization, quality of life, cost analysis

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanquin Research & Blood Bank Divisions
• Collaborators: Haemonetics Corporation; Roche BV Netherlands; ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Orthopaedic patients of 18 years and older being scheduled for a primary or revision total knee (TKR) or total hip replacement (THR).

Exclusion Criteria:

• Patients who refuse homologous blood (e.g.Jehovah's witnesses),

• Patients with untreated hypertension (diastolic blood pressure > 95 mm Hg),

• Patients with a serious disorder of the coronary artery, peripheral arteries and/or carotid arteries,

• A recent myocardial infarction or CVA,

• Sickle cell anaemia patients,

• Malignancy in the operated area,

• Pregnancy,

• Unsuitability for peri-operative anticoagulation prophylaxis,

• Known allergy to erythropoietin,

• An infected wound bed,

• Revision of an infected prosthesis which is being treated with antibiotics, OR

• Patients with difficulty understanding the Dutch language (unable to give informed consent or patients who insufficiently control the Dutch language).