Condition category
Surgery
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
02/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr S.C. Marczinski

ORCID ID

Contact details

Willy Brandtlaan 10
Ede
6716 RP
Netherlands
+31 (0)318 435546
Marczinskis@zgv.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UMCU 04-298; NTR175

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised, double-blinded, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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 names

Desmopressin

Primary outcome measures

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 trial start date

01/01/2005

Overall trial end date

01/06/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

300. Patients have been recruited since 07/04/05.

Participant 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

Recruitment start date

01/01/2005

Recruitment end date

01/06/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Willy Brandtlaan 10
Ede
6716 RP
Netherlands

Sponsor information

Organisation

Hospital Gelderse Vallei (The Netherlands)

Sponsor details

P.O. Box 9025
Ede
6710 HN
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Hospital Gelderse Vallei (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes