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NCT01528943 Clinical Trial

Effect of Prostacyclin on Haemostasis in Abdominal Surgery

Surgery Clinical Trial

Official title:
The Effect of Prostacyclin on Haemostasis as Evaluated by Thrombelastography and Endothelial Markers in Patients Undergoing Major Abdominal Surgery. A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01528943
Other study ID # ET Abdominal
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 2012
Est. completion date January 2014

Study information
Verified date March 2021
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of continuous perioperative infusion of prostacyclin on haemostasis and endothelial functionality in patients undergoing major abdominal surgery.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date January 2014
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Men and women above 18 years old - Undergoing Whipple surgery or liver resection - Able and willing to give informed consent Exclusion Criteria: 1. Allergy towards the study medication 2. In treatment with platelet ADP receptor inhibitors or heparin (not including thrombosis prophylaxis), Factor Xa inhibitors, trombininhibitors, Vitamin K antagonists 3. Autoimmune disease 4. Intracranial bleeding within the last 6 months 5. Acute coronary syndrome or myocardial infarction within the last 6 months 6. Congestive heart disease 7. Pregnant or breastfeeding 8. Participating in another clinical study within the last 30 days 9. Liver cirrhosis 10. Need for renal replacement therapy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Prostacycline
Continuous infusion peri -and 6 hours postoperatively of prostacycline 1 ng/kg/min
• Isotonic saline
same volume as the group that are allocated to prostacycline

Locations
Country Name City State
Denmark Rigshospitalet Copenhagen Zealand

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in endothelial biomarkers Baseline to 6 hours postoperatively
Secondary Functional haemostasis evaluated by thrombelastography Baseline to 6 hours postoperatively
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