Blood Management in Orthopedic Surgery

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Device: OrthoPAT; Device: Post-operative drain device; Other: erythropoietin and cell saver; Other: Erythropoietin and drain device; Drug: erythropoietin; Other: Erythropoietin and OrthoPAT

• Registration Number: NCT00998088
• Lead Sponsor: Sanquin Research & Blood Bank Divisions

Brief 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).

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2009-10
• Study First Submitted: 2009-10-19
• Study First Submitted QC: 2009-10-19
• Last Update Submitted: 2009-10-19
• Study First Posted: 2009-10-20
• Last Update Posted: 2009-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2598

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
cell saver	OrthoPAT	-
drain	Post-operative drain device	-
Erythropoietin and cell saver	erythropoietin and cell saver	-
Erythropoietin and cell saver	Erythropoietin and OrthoPAT	-
Erythropoietin and drain	Erythropoietin and drain device	-
Erythropoietin	erythropoietin	-

Primary Outcome Measures

Name	Time	Method
Number of allogeneic red blood cell (RBC) transfusions.	up to 3 months after surgery

Secondary Outcome Measures

Name	Time	Method
Harris hip / knee society score (for determination of the mobility of the operated joint)	pre-operative and after 3 months
Cost analysis	up to 3 months after surgery
Length of hospital stay	In hospital
Peri- and post-operative complications during hospitalization	up to 3 months after surgery
Rehabilitation time	in hospital
Hb/Ht post-operative	at 14 days and 3 months after surgery
Quality of life	Up to 3 months after surgery
Transfusion reactions	up to 3 months after surgery

Trial Locations

Locations (4)

Slotervaart Hospital; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Groene Hart Hospital; 🇳🇱 Gouda, Zuid Holland, Netherlands

LUMC; 🇳🇱 Leiden, Zuid-Holland, Netherlands

Albert Schweitzer Hospital; 🇳🇱 Dordrecht, Zuid-Holland, Netherlands