Preoperative Acute Normovolaemic Haemodilution (ANH) in combination with Hypotensive Epidural Anaesthesia (HEA)
| ISRCTN | ISRCTN87597684 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87597684 |
| Protocol serial number | N/A |
| Sponsor | Aarhus University Hospital (Denmark) |
| Funder | Not provided at time of registration |
- Submission date
- 12/04/2002
- Registration date
- 12/04/2002
- Last edited
- 06/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Palle Juelsgaard
Scientific
Scientific
Department of Anaesthesia
Aarhus University Hospital
Aarhus Amtssygehus
DK-8000
Denmark
| Phone | +45 89497575 |
|---|---|
| Palle.Juelsgaard@aas.auh.dk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Knee arthroplasty surgery |
| Intervention | Patients were consecutive and blindly randomised to hypotensive epidural anaesthesia with or without acute normovolaemic haemodilution. A mean of 877 ml blood was predonated (19.7% of the total blood volume). Blood loss was, except from the intraoperative loss, significantly higher in the ANH group. The total loss was 1306 mL (ANH) versus 1026 mL (non-ANH), P < 0.05. Except from the first hour postoperatively, haematocrit was identical in between groups postoperatively. The amount of blood transfusion was identical 386 ml (ANH) versus 343 ml (non-ANH) (NS). 50% went through surgery without receiving blood (ANH) versus 58% (non-ANH). No renal, neurological or cardiopulmonary complications were registered. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 28 |
| Key inclusion criteria | Patients scheduled for primary cemented Total Knee Replacement (TKR) surgery |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 01/01/2001 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Department of Anaesthesia
Aarhus Amtssygehus
DK-8000
Denmark
DK-8000
Denmark
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 | 18/04/2002 | Yes | No |
