Condition category
Surgery
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
05/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Cynthia So-Osman

ORCID ID

Contact details

Sanquin Bloodbank ZW
Plesmanlaan 1a
Leiden
2333 BZ
Netherlands
+31 (0)71 568 5136
C.So@sanquin.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR303; ZonMW: 945-06-601

Study information

Scientific title

Acronym

TOMaat study

Study hypothesis

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

Received from the local medical ethics committee

Study design

Multicentre randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/05/2004

Overall trial end date

01/10/2009

Reason abandoned

Eligibility

Participant 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).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2250

Participant 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

Recruitment start date

01/05/2004

Recruitment end date

01/10/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Sanquin Bloodbank ZW
Leiden
2333 BZ
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (Netherlands)

Sponsor details

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

University/education

Website

http://www.lumc.nl/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Roche Nederland BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Haemonetics BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Sanquin Bloodbank Amsterdam (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes