Blood Management in Orthopedic Surgery

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

Conditions

• Osteoarthritis

Interventions

OTHER

erythropoietin and cell saver

weekly 40.000 IU s.c. for 4 weeks pre-operatively; use of cell saver includes intra- and post-operative drainage and reinfusion

DRUG

erythropoietin

weekly 40.000 IU s.c. for 4 weeks pre-operatively

DEVICE

OrthoPAT

for intra- and post-operative re-infusion of autologous wound blood

DEVICE

Post-operative drain device

For post-operative re-infusion of unwashed wound blood

OTHER

Erythropoietin and OrthoPAT

weekly 40.000 IU s.c. for 4 weeks pre-operatively

OTHER

Erythropoietin and drain device

weekly 40.000 IE s.c.for 4 weeks pre-operatively; drain use in post-operative period

DEVICE

OrthoPAT

For intra- and post-operative reinfusion of autologous blood

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Roche BV Netherlands

  collaborator UNKNOWN

• Haemonetics Corporation

  collaborator INDUSTRY

• Sanquin Research & Blood Bank Divisions

  lead OTHER

Principal Investigators

• Rob Nelissen, MD, PhD · Leiden University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-05-31

Primary Completion

2009-09-30

Completion

2009-09-30

Countries

• Netherlands

Study Locations