Reduction of allogenic blood transfusion and increased activation of coagulation by re-infusion of post-operative autologous wound blood in patients undergoing total knee and total hip replacement

ISRCTN ISRCTN55488814
DOI https://doi.org/10.1186/ISRCTN55488814
Secondary identifying numbers 0419
Submission date
10/10/2011
Registration date
12/03/2012
Last edited
19/05/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
During an operation to replace your hip or knee there is often considerable blood loss. It is possible to collect your own blood from the wound area and return it to you by re-infusion within 6 hours after the operation. This might reduce the number of blood transfusions that you may need after this kind of operation. However, this has never been proven. In addition, it is also not known if re-infusion of wound blood is completely safe. Theoretically, re-infusion of wound blood might lead to activation of your coagulation (clotting) system and therefore to an increased risk of thrombosis (blood clots). Therefore this study will investigate whether re-infusion of wound blood leads to an reduction of blood transfusion, and whether re-infusion of wound blood leads to activation of the coagulation system and to an increased risk of thrombosis.

Who can participate?
Patients aged 18 or older who need a hip or knee replacement.

What does the study involve?
Participants will be divided into two groups: one group will receive their own wound blood within 6 hours after the operation, whereas the other group will not. After the study has finished the number of blood transfusions will be compared between the two groups of patients. A number of laboratory coagulation tests will be carried out and the number of patients who have developed thrombosis will be compared between the two groups.

What are the possible benefits and risks of participating?
Several hospitals in the Netherlands that perform knee and hip replacement operations already use the practice of re-infusion of the patients own wound blood. The Medical Ethical Committee therefore concluded that there is no increased risk for participants.

Where is the study run from?
Maxima Medical Centre, Eindhoven, the Netherlands.

When is the study starting and how long is it expected to run for?
The study took place from May 2004 to February 2006.

Who is funding the study?
Maxima Medical Centre, Eindhoven, the Netherlands.

Who is the main contact?
Dr Arnold T. Besselaar

Contact information

Dr Arnold T. Besselaar
Scientific

Michelangelolaan 2
Eindhoven
5653EJ
Netherlands

Study information

Study designRandomised double-blind controlled observational single-centre study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomized controlled double-blind observational trial of re-infusion of post-operative, autologous wound blood in patients undergoing total knee or hip arthroplasty: efficacy (reduction of allogenic blood transfusion) and activation of coagulation (increased coagulation activation in comparison to control group)
Study objectivesThe principle questions of the study are:
1. Can the number of allogenic blood transfusions in orthopaedic patients, be reduced by post operatively re-infused autologous wound blood
2. Does reinfusion of post-operative autologous wound blood lead to increased activation of coagulation in orthopaedic patients undergoing total hip or knee replacement
Ethics approval(s)The Medical Ethical Board of the Maxima Medical Centre Eindhoven, 15/04/2004, ref: 0419
Health condition(s) or problem(s) studiedDegenerative arthritis in hip or knee
InterventionPre and at various post operative timepoints blood samples are taken for analysis of several haematological and coagulation parameters [e.g. haemoglobin (Hb), leucocytes, prothrombin time (PT), activated partial thromboplastin time (APTT) and coagulation activation parameters such as thrombin-antithrombin III complexes (TAT), prothrombin fragment (PF) 1+2 and d-dimers]. The numbers of allogenic blood transfusions is registred according to a strict transfusion protocol. In addition 2 weeks post operatively a colour duplex sonography is performed.
Intervention typeProcedure/Surgery
Primary outcome measure1. Hb, APTT, PT, Fibrinogen, TAT, PF 1 + 2 and d-dimer are measured in blood samples taken 12 hours pre operatively and at 3 hours postoperatively and 1 and 4 hours after re-infusion of autologous wound blood and at 24 hours, 14 days, 6 weeks and 3 months post operatively.
2. The number of allogenic blood tranfusions is registred. Allogenic bloodtransfusion is given according to a strictly handled tranfusion protocol
3. Two weeks post operatively a colour duplex sonography is performed
Secondary outcome measures1. Number of post-operative transfusion reactions
2. Number of secondary wound infections
Overall study start date12/05/2004
Completion date01/02/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants130
Key inclusion criteria1. Patients aged 18 years or older
2. An indication exists for total knee or hip replacement
Key exclusion criteria1. Who were using coumarin derivates or heparin
2. Suffering from malignancies or with a history of malignancy within the previous 5 years
3. With a history of venous thromboembolic disease
4. Indicated for revision surgery
5. With less than 100ml collected autologous wound blood
Date of first enrolment12/05/2004
Date of final enrolment01/02/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Michelangelolaan 2
Eindhoven
5653EJ
Netherlands

Sponsor information

Maxima Medical Centre (Netherlands)
Hospital/treatment centre

Postbus 7777
Veldhoven
5500MB
Netherlands

Website http://www.mmc.nl/
ROR logo "ROR" https://ror.org/02x6rcb77

Funders

Funder type

Hospital/treatment centre

Maxima Medical Centre Eindhoven - Local Scientific Foundation (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan