Are autotransfusion drains effective for total knee arthroplasty? A randomised controlled trial
| ISRCTN | ISRCTN65166542 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65166542 |
| Protocol serial number | N0114126741 |
| Sponsor | Department of Health |
| Funder | Colchester Hospital University NHS Foundation Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 16/05/2012
- 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
Mr M Loeffler
Scientific
Scientific
Colchester General Hospital
Department of Orthopaedics
Turner Road
Colchester
CO4 5JL
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Do autotransfusion drains obviate the need for formal blood transfusion with cross-matched blood after total knee arthroplasty? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Knee arthroplasty |
| Intervention | At the pre-admission clinic the patients will be randomly allocated into one of two groups (50 patients in each group) after discussing the project with them, providing them with a patients information leaflet and consenting them. One group will receive all their post operatively drained wound blood back as an autotransfusion using the "Bellovac" autotransfusion drain system. The other group will have their wound blood discarded and be transfused according to preset criteria. The autotransfused patients may need additional transfusion with cross-matched blood if they fail to meet the preset criteria. Transfusion criteria: 1. A loss of >1000 ml of blood in the collection drain; 2. A clinical need for transfusion (Tachycardia, hypotensive, ischaemic electrocardiogram [ECG] changes) 3. A haemoglobin blood level of <8.5 g/dl. The data will be collated to determine by simple non-parametric statistical analysis whether autotransfusion drains are useful in obviating the need for conventional transfusion with cross-matched donated blood. A publication in the Journal of Bone and Joint Surgery is anticipated. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Post operative Haemoglobin levels (checked at 12, 24 and 72 hours) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | 100 patients will be selected for this study. All patients will need total knee replacements. |
| Key exclusion criteria | Patients with bleeding disorders, Jehovah's witnesses and those not wishing to enter the study will be excluded. |
| Date of first enrolment | 01/07/2003 |
| Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Colchester General Hospital
Colchester
CO4 5JL
United Kingdom
CO4 5JL
United Kingdom
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 | 01/04/2008 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
