NCT00998088

Blood Management in Orthopedic Surgery

Optimal Blood Management in Elective Orthopaedic Surgery: The Transfusion "Op Maat" (TOMaat) Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,598 (actual)
• Sponsor: Sanquin Research & Blood Bank Divisions · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Power/data analysis: In order to be able to detect a 75% reduction of allogeneic transfusions by Epo and a reduction of 30% by autologous (shed blood) transfusions (CS or D) with a power= 0.9 and an alpha= 0.05, inclusion of 2250 surgery patients (in a worst case scenario of high standard deviations) are required for intention-to-treat analysis. Knee surgery patients are not randomized for cell saver (no intra-operative blood loss).

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-05-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2009-10-20
• Last updated: 2009-10-20

Locations

4 sites across 1 country: Netherlands