Blood Management in Orthopedic Surgery (TOMaat)

This study has been completed.
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Roche BV Netherlands
Haemonetics Corporation
Information provided by:
Sanquin Research & Blood Bank Divisions
ClinicalTrials.gov Identifier:
NCT00998088
First received: October 19, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

October 19, 2009
October 19, 2009
May 2004
September 2009   (final data collection date for primary outcome measure)
Number of allogeneic red blood cell (RBC) transfusions. [ Time Frame: up to 3 months after surgery ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Peri- and post-operative complications during hospitalization [ Time Frame: up to 3 months after surgery ] [ Designated as safety issue: No ]
  • Rehabilitation time [ Time Frame: in hospital ] [ Designated as safety issue: No ]
  • Hb/Ht post-operative [ Time Frame: at 14 days and 3 months after surgery ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Up to 3 months after surgery ] [ Designated as safety issue: No ]
  • Transfusion reactions [ Time Frame: up to 3 months after surgery ] [ Designated as safety issue: Yes ]
  • Harris hip / knee society score (for determination of the mobility of the operated joint) [ Time Frame: pre-operative and after 3 months ] [ Designated as safety issue: No ]
  • Cost analysis [ Time Frame: up to 3 months after surgery ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: In hospital ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Blood Management in Orthopedic Surgery
Optimal Blood Management in Elective Orthopaedic Surgery: The Transfusion "Op Maat" (TOMaat) Study

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis
  • 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:
    • Eprex, Ortho-Biotech
    • Neorecormon, Roche
  • Device: OrthoPAT
    for intra- and post-operative re-infusion of autologous wound blood
    Other Name: 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 Name: OrthoPAT, Haemonetics
  • Experimental: Erythropoietin
    Intervention: Drug: erythropoietin
  • No Intervention: Control arm
  • Experimental: cell saver
    Interventions:
    • Device: OrthoPAT
    • Device: OrthoPAT
  • Experimental: drain
    Intervention: Device: Post-operative drain device
  • Experimental: Erythropoietin and cell saver
    Interventions:
    • Other: erythropoietin and cell saver
    • Other: Erythropoietin and OrthoPAT
  • Experimental: Erythropoietin and drain
    Intervention: Other: Erythropoietin and drain device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2598
September 2009
September 2009   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00998088
ISRCTN96327523, ISRCTN96327523, NTR303, ZonMW945-06-601, Sanquin PPOC-03-002
Yes
Prof. Dr.R.G.H.H.Nelissen, Leiden University Medical Center
Sanquin Research & Blood Bank Divisions
  • ZonMw: The Netherlands Organisation for Health Research and Development
  • Roche BV Netherlands
  • Haemonetics Corporation
Principal Investigator: Rob Nelissen, MD, PhD Leiden University Medical Center
Sanquin Research & Blood Bank Divisions
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP