Blood Management in Orthopedic Surgery
TOMaat
Optimal Blood Management in Elective Orthopaedic Surgery: The Transfusion "Op Maat" (TOMaat) Study
4 other identifiers
interventional
2,598
1 country
4
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2004
Longer than P75 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 19, 2009
CompletedFirst Posted
Study publicly available on registry
October 20, 2009
CompletedOctober 20, 2009
October 1, 2009
5.3 years
October 19, 2009
October 19, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of allogeneic red blood cell (RBC) transfusions.
up to 3 months after surgery
Secondary Outcomes (8)
Peri- and post-operative complications during hospitalization
up to 3 months after surgery
Rehabilitation time
in hospital
Hb/Ht post-operative
at 14 days and 3 months after surgery
Quality of life
Up to 3 months after surgery
Transfusion reactions
up to 3 months after surgery
- +3 more secondary outcomes
Study Arms (6)
Erythropoietin
EXPERIMENTALControl arm
NO INTERVENTIONcell saver
EXPERIMENTALdrain
EXPERIMENTALErythropoietin and cell saver
EXPERIMENTALErythropoietin and drain
EXPERIMENTALInterventions
weekly 40.000 IU s.c. for 4 weeks pre-operatively; use of cell saver includes intra- and post-operative drainage and reinfusion
weekly 40.000 IU s.c. for 4 weeks pre-operatively
for intra- and post-operative re-infusion of autologous wound blood
For post-operative re-infusion of unwashed wound blood
weekly 40.000 IU s.c. for 4 weeks pre-operatively
weekly 40.000 IE s.c.for 4 weeks pre-operatively; drain use in post-operative period
Eligibility Criteria
You may qualify if:
- Orthopaedic patients of 18 years and older being scheduled for a primary or revision total knee (TKR) or total hip replacement (THR).
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanquin Research & Blood Bank Divisionslead
- ZonMw: The Netherlands Organisation for Health Research and Developmentcollaborator
- Roche BV Netherlandscollaborator
- Haemonetics Corporationcollaborator
Study Sites (4)
Slotervaart Hospital
Amsterdam, North Holland, Netherlands
Albert Schweitzer Hospital
Dordrecht, South Holland, Netherlands
Groene Hart Hospital
Gouda, South Holland, Netherlands
LUMC
Leiden, South Holland, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rob Nelissen, MD, PhD
Leiden University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 19, 2009
First Posted
October 20, 2009
Study Start
May 1, 2004
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
October 20, 2009
Record last verified: 2009-10