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Blood Management in Orthopedic Surgery (TOMaat)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00998088
First Posted: October 20, 2009
Last Update Posted: October 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Roche BV Netherlands
Haemonetics Corporation
Information provided by:
Sanquin Research & Blood Bank Divisions
  Purpose

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


Condition Intervention Phase
Osteoarthritis Other: erythropoietin and cell saver Drug: erythropoietin Device: OrthoPAT Device: Post-operative drain device Other: Erythropoietin and OrthoPAT Other: Erythropoietin and drain device Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Blood Management in Elective Orthopaedic Surgery: The Transfusion "Op Maat" (TOMaat) Study

Resource links provided by NLM:


Further study details as provided by Sanquin Research & Blood Bank Divisions:

Primary Outcome Measures:
  • Number of allogeneic red blood cell (RBC) transfusions. [ Time Frame: up to 3 months after surgery ]

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

Enrollment: 2598
Study Start Date: May 2004
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erythropoietin Drug: erythropoietin
weekly 40.000 IU s.c. for 4 weeks pre-operatively
Other Names:
  • Eprex, Ortho-Biotech
  • Neorecormon, Roche
No Intervention: Control arm
Experimental: cell saver Device: OrthoPAT
for intra- and post-operative re-infusion of autologous wound blood
Other Name: OrthoPAT, Haemonetics
Device: OrthoPAT
For intra- and post-operative reinfusion of autologous blood
Other Name: OrthoPAT, Haemonetics
Experimental: drain 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
Experimental: Erythropoietin and cell saver 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
Other: Erythropoietin and OrthoPAT
weekly 40.000 IU s.c. for 4 weeks pre-operatively
Other Names:
  • Eprex, Ortho-Biotech
  • Neorecormon, Roche
  • OrthoPAT, Haemonetics
Experimental: Erythropoietin and drain 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

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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00998088


Locations
Netherlands
Slotervaart Hospital
Amsterdam, Noord-Holland, Netherlands
Groene Hart Hospital
Gouda, Zuid Holland, Netherlands
Albert Schweitzer Hospital
Dordrecht, Zuid-Holland, Netherlands
LUMC
Leiden, Zuid-Holland, Netherlands
Sponsors and Collaborators
Sanquin Research & Blood Bank Divisions
ZonMw: The Netherlands Organisation for Health Research and Development
Roche BV Netherlands
Haemonetics Corporation
Investigators
Principal Investigator: Rob Nelissen, MD, PhD Leiden University Medical Center
  More Information

Responsible Party: Prof. Dr.R.G.H.H.Nelissen, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT00998088     History of Changes
Other Study ID Numbers: ISRCTN96327523
NTR303
ZonMW945-06-601
Sanquin PPOC-03-002
First Submitted: October 19, 2009
First Posted: October 20, 2009
Last Update Posted: October 20, 2009
Last Verified: October 2009

Keywords provided by Sanquin Research & Blood Bank Divisions:
Blood management
Orthopedic surgery
elective
randomized study
adults
hip replacement
knee replacement

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Epoetin Alfa
Hematinics