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Use of preoperative desmopressin in preventing bleeding in patients treated with SSRI's.


- candidate number1300
- NTR NumberNTR175
- ISRCTNISRCTN10353850
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR1-sep-2005
- Secondary IDs04-298 UMCU
- Public TitleUse of preoperative desmopressin in preventing bleeding in patients treated with SSRI's.
- Scientific TitleUse of preoperative desmopressin in preventing bleeding in patients treated with SSRI's.
- ACRONYMN/A
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedPrimary hemostasis disorder
- Inclusion criteria1. 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.
- Exclusion criteria1. No informed consent;
2. Disorder in primary hemostasis;
3. Hyponatremia (sodium (serum) < 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 anesthesia during surgery.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 7-apr-2005
- planned closingdate31-dec-2007
- Target number of participants45
- InterventionsPreoperative infusion placebo / desmopressin (< 50 kg: 15 mcg, 50-100kg: 30 mcg, > 100 kg: 45 mcg).
- Primary outcomePeri- and postoperative blood loss.
- Secondary outcome1. Pre- and postoperative hemoglobin;
2. Number of perioperative blood transfusion;
3. Perioperative fluid infusion;
4. Postoperative drainage.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. S.C. Marczinski
- CONTACT for SCIENTIFIC QUERIESDrs. S.C. Marczinski
- Sponsor/Initiator Hospital Gelderse Vallei
- Funding
(Source(s) of Monetary or Material Support)
Hospital Gelderse Vallei Ede
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD25-aug-2005 - 18-jan-2010


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