Optimal blood management in elective orthopaedic surgery: the Transfusion "Op Maat" (TOMaat) study

ISRCTN	ISRCTN96327523
DOI	https://doi.org/10.1186/ISRCTN96327523
Clinical Trials Information System (CTIS)	NCT00998088
Protocol serial number	NTR303; ZonMW: 945-06-601
Sponsor	Leiden University Medical Centre (LUMC) (Netherlands)
Funders	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands), Roche Nederland BV (Netherlands), Haemonetics BV (Netherlands), Sanquin Bloodbank Amsterdam (Netherlands)

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 26/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Cynthia So-Osman
Scientific

Sanquin Bloodbank ZW
Plesmanlaan 1a
Leiden
2333 BZ
Netherlands

Phone	+31 (0)71 568 5136
Email	C.So@sanquin.nl

Study information

Primary study design	Interventional
Study design	Multicentre randomised active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	Optimal blood management in elective orthopaedic surgery: the Transfusion "Op Maat" (TOMaat) study
Study acronym	TOMaat
Study objectives	Does the use of alternatives to allogeneic blood (erythropoietin or reinfusion of autologous shed blood intra- and/or post-operatively) for patients undergoing elective total knee- or hip replacement surgery lead to continuous sparing of allogeneic blood if a restrictive transfusion policy is in operation? As of 05/06/2009 this record has been updated to include an amended anticipated end date; the initial end date at the time of registration was 31/12/2008.
Ethics approval(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Total Knee Replacement (TKR)/Total Hip Replacement (THR)
Intervention	Stratification depending on the pre-operative Hemoglobin (Hb) level: Stratum I: Hb greater than 6.1 mmol/L or less than 8.2 mmol/L (eligible for Epo randomisation) Stratum II: Hb less than 6.2 mmol/L or greater than 8.1 mmol/L (not eligible for Epo) Patients in both strata will be sequentially randomised for: 1. No use of autologous wound-drained blood (control group) 2. Post-operative retransfusion of wound-drained blood, or 3. Peri-operative use of the cell saver with post-operative retransfusion of wound-drained blood Enrolment for this trial was completed on 31/10/2008.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Number of red blood cell (RBC) transfusions in the following blood management strategies: 1. Comparison of Epo versus no Epo 2. Comparison of cell saver versus no cell saver 3. Comparison of drain system versus no drain system, independent of cell saver
Key secondary outcome measure(s)	1. Post-operative complications 2. Length of hospital stay (LOHS) 3. Post-operative Hb/haematocrit (Hct) 4. Rehabilitation time 5. Mobility and functional abilities of knee-or hip 6. Quality of life scores 7. Costs analysis
Completion date	01/10/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	2250
Total final enrolment	3689
Key inclusion criteria	All orthopedic patients of 18 years and older being considered for a primary or revision total knee replacement (TKR) or total hip replacement (THR).
Key exclusion criteria	1. Refusal of allogeneic blood 2. Pregnancy 3. Patients with uncontrolled hypertension 3. Cardiac instability 4. Recent CVA 5. Symptomatic atherosclerosis 6. Sickle cell anaemia 7. Cancer in the wound area 8. Unsuitability for peri-operative anticoagulation prophylaxis 9. Known allergy to erythropoietin 10. Infected prosthesis or wound
Date of first enrolment	01/05/2004
Date of final enrolment	01/10/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Sanquin Bloodbank ZW

Leiden
2333 BZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/09/2020	26/01/2021	Yes	No

Editorial Notes

26/01/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
14/02/2020: ClinicalTrials.gov number added.