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Completed

NCT Number: NCT00998088

Blood Management in Orthopedic Surgery

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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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Slotervaart Hospital, Amsterdam, North Holland, Netherlands

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

erythropoietin and cell saver

Other

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

Erythropoietin

Drug

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

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

OrthoPAT

Device

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

Other names: OrthoPAT, Haemonetics

Post-operative drain device

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

Erythropoietin and OrthoPAT

Other

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

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

Erythropoietin and drain device

Other

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

Primary outcomes

  1. Number of allogeneic red blood cell (RBC) transfusions.

    Time frame: up to 3 months after surgery

Secondary outcomes

  1. Peri- and post-operative complications during hospitalization

    Time frame: up to 3 months after surgery

  2. Rehabilitation time

    Time frame: in hospital

  3. Hb/Ht post-operative

    Time frame: at 14 days and 3 months after surgery

  4. Quality of life

    Time frame: Up to 3 months after surgery

  5. Transfusion reactions

    Time frame: up to 3 months after surgery

  6. Harris hip / knee society score (for determination of the mobility of the operated joint)

    Time frame: pre-operative and after 3 months

  7. Cost analysis

    Time frame: up to 3 months after surgery

  8. Length of hospital stay

    Time frame: In hospital

Sponsors and collaborators

Lead sponsor

Sanquin Research & Blood Bank Divisions

Other

Collaborators

  • Haemonetics Corporation
  • Roche BV Netherlands
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: TOMaat

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Oct 20, 2009
Registry last updated
Oct 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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