Use of preoperative desmopressin in preventing bleeding in patients treated with selective serotonin reuptake inhibitors (SSRIs)
| ISRCTN | ISRCTN10353850 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10353850 |
| Secondary identifying numbers | UMCU 04-298; NTR175 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 02/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S.C. Marczinski
Scientific
Scientific
Willy Brandtlaan 10
Ede
6716 RP
Netherlands
| Phone | +31 (0)318 435546 |
|---|---|
| Marczinskis@zgv.nl |
Study information
| Study design | Randomised, double-blinded, placebo controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | Primary haemostasis disorder |
| Intervention | Pre-operative infusion placebo/desmopressin: 1. Less than 50 kg: 15 µg 2. 50 - 100 kg: 30 µg 3. Greater than 100 kg: 45 µg |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Desmopressin |
| Primary outcome measure | Pre- and post-operative blood loss. |
| Secondary outcome measures | 1. Peri- and post-operative haemoglobin 2. Number of peri-operative blood transfusion 3. Peri-operative fluid infusion 4. Post-operative drainage |
| Overall study start date | 01/01/2005 |
| Completion date | 01/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 300. Patients have been recruited since 07/04/05. |
| Key inclusion criteria | 1. Patients aged over 18 who receive a serotonergic antidepressant (fluvoxamine, fluoxetine, paroxetine, sertraline, venlafaxine, clomipramine, citalopram) at least started two weeks before the surgery 2. Surgery: orthopedic, abdominal, breast |
| Key exclusion criteria | 1. No informed consent 2. Disorder in primary haemostasis 3. Hyponatraemia (sodium [serum] less than 130 mmol/l) 4. Laparoscopic surgery 5. Use of vitamin K antagonists, aspirin, iron supplements, methotrexate, heparin 6. Acute coronary syndrome (unstable angina and myocardial infarction) 7. Spinal anaesthesia during surgery |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/06/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Willy Brandtlaan 10
Ede
6716 RP
Netherlands
6716 RP
Netherlands
Sponsor information
Hospital Gelderse Vallei (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 9025
Ede
6710 HN
Netherlands
"ROR" |
https://ror.org/03862t386 |
|---|
Funders
Funder type
Hospital/treatment centre
Hospital Gelderse Vallei (The 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 |
