Trial | NCT00998088  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    epoetin ...

  • Study Participants

    2598
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
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).
Study Started
May 31
2004
Primary Completion
Sep 30
2009
Study Completion
Sep 30
2009
Last Update
Oct 20
2009
Estimate

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

  • Other names: Eprex, Ortho-Biotech, Neorecormon, Roche, OrthoPAT, Haemonetics

Drug erythropoietin

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

  • Other names: Neorecormon, Roche, Eprex, Ortho-Biotech

Device OrthoPAT

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

  • Other names: OrthoPAT, Haemonetics

Device Post-operative drain device

For post-operative re-infusion of unwashed wound blood

  • Other names: Bellovac-ABT, Astra-Tech, The Netherlands, DONOR-drain, Van Straten Medical, The Netherlands

Other Erythropoietin and OrthoPAT

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

  • Other names: Eprex, Ortho-Biotech, Neorecormon, Roche, OrthoPAT, Haemonetics

Other Erythropoietin and drain device

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

  • Other names: Eprex, Ortho-Biotech, Neorecormon, Roche, Bellovac-ABT, Astra-Tech, DONOR-drain, Van Straten Medical

Device OrthoPAT

For intra- and post-operative reinfusion of autologous blood

  • Other names: OrthoPAT, Haemonetics

Erythropoietin and cell saver Experimental

Erythropoietin and drain Experimental

Erythropoietin Experimental

Control arm No Intervention

cell saver Experimental

drain Experimental

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).
No Results Posted