Blood Management in Orthopedic Surgery (TOMaat)

Sanquin Research & Blood Bank Divisions

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis

Treatments: Device: OrthoPAT; Drug: erythropoietin; Other: Erythropoietin and OrthoPAT; Other: erythropoietin and cell saver; Other: Erythropoietin and drain device; Device: Post-operative drain device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00998088

Sanquin PPOC-03-002

ISRCTN96327523

ZonMW945-06-601

NTR303

Details and patient eligibility

About

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

Full 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).

Enrollment: 2,598 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

2,598 participants in 6 patient groups

Erythropoietin

Experimental group

Treatment:

Drug: erythropoietin

Control arm

No Intervention group

cell saver

Experimental group

Treatment:

Device: OrthoPAT

Device: OrthoPAT

drain

Experimental group

Treatment:

Device: Post-operative drain device

Erythropoietin and cell saver

Experimental group

Treatment:

Other: erythropoietin and cell saver

Other: Erythropoietin and OrthoPAT

Erythropoietin and drain

Experimental group

Treatment:

Other: Erythropoietin and drain device