Optimal blood management in elective orthopaedic surgery: the Transfusion "Op Maat" (TOMaat) study
| ISRCTN | ISRCTN96327523 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96327523 |
| EudraCT/CTIS number | NCT00998088 |
| Secondary identifying numbers | NTR303; ZonMW: 945-06-601 |
- 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
Scientific
Sanquin Bloodbank ZW
Plesmanlaan 1a
Leiden
2333 BZ
Netherlands
| Phone | +31 (0)71 568 5136 |
|---|---|
| C.So@sanquin.nl |
Study information
| Study design | Multicentre randomised active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/05/2004 |
| Completion date | 01/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
2333 BZ
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (Netherlands)
University/education
University/education
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/ |
|---|---|
"ROR" |
https://ror.org/027bh9e22 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
No information available
Roche Nederland BV (Netherlands)
No information available
Haemonetics BV (Netherlands)
No information available
Sanquin Bloodbank Amsterdam (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
