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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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, ISRCTN96327523, NTR303, ZonMW945-06-601, Sanquin PPOC-03-002
Study First Received: October 19, 2009
Last Updated: October 19, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014