Blood Management in Orthopedic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2598 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2009-09-30

Brief Summary

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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

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Detailed Description

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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

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Erythropoietin

Group Type EXPERIMENTAL

erythropoietin

Intervention Type DRUG

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

Control arm

Group Type NO_INTERVENTION

No interventions assigned to this group

cell saver

Group Type EXPERIMENTAL

OrthoPAT

Intervention Type DEVICE

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

OrthoPAT

Intervention Type DEVICE

For intra- and post-operative reinfusion of autologous blood

drain

Group Type EXPERIMENTAL

Post-operative drain device

Intervention Type DEVICE

For post-operative re-infusion of unwashed wound blood

Erythropoietin and cell saver

Group Type EXPERIMENTAL

erythropoietin and cell saver

Intervention Type OTHER

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

Erythropoietin and OrthoPAT

Intervention Type OTHER

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

Erythropoietin and drain

Group Type EXPERIMENTAL

Erythropoietin and drain device

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

erythropoietin

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

Intervention Type DRUG

OrthoPAT

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

Intervention Type DEVICE

Post-operative drain device

For post-operative re-infusion of unwashed wound blood

Intervention Type DEVICE

Erythropoietin and OrthoPAT

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

Intervention Type OTHER

Erythropoietin and drain device

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

Intervention Type OTHER

OrthoPAT

For intra- and post-operative reinfusion of autologous blood

Intervention Type DEVICE

Other Intervention Names

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Eprex, Ortho-Biotech Neorecormon, Roche OrthoPAT, Haemonetics Eprex, Ortho-Biotech Neorecormon, Roche OrthoPAT, Haemonetics Bellovac-ABT, Astra-Tech, The Netherlands DONOR-drain, Van Straten Medical, The Netherlands Eprex, Ortho-Biotech Neorecormon, Roche OrthoPAT, Haemonetics Eprex, Ortho-Biotech Neorecormon, Roche Bellovac-ABT, Astra-Tech DONOR-drain, Van Straten Medical OrthoPAT, Haemonetics

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No