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
Protocol serial number	UMCU 04-298; NTR175
Sponsor	Hospital Gelderse Vallei (The Netherlands)
Funder	Hospital Gelderse Vallei (The Netherlands)

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

Dr S.C. Marczinski
Scientific

Willy Brandtlaan 10
Ede
6716 RP
Netherlands

Phone	+31 (0)318 435546
Email	Marczinskis@zgv.nl

Primary study design	Interventional
Study design	Randomised, double-blinded, placebo controlled, parallel group 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	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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Desmopressin
Primary outcome measure(s)	Pre- and post-operative blood loss.
Key secondary outcome measure(s)	1. Peri- and post-operative haemoglobin 2. Number of peri-operative blood transfusion 3. Peri-operative fluid infusion 4. Post-operative drainage
Completion date	01/06/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	300
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

Willy Brandtlaan 10

Ede
6716 RP
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan