Effect of Prostacyclin on Haemostasis in Abdominal Surgery

Phase 1

Completed

• Conditions: Surgery
• Interventions: Drug: Prostacycline; Drug: Isotonic saline

• Registration Number: NCT01528943
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-05
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-08
• Study Start: 2012-03
• Primary Completion: 2013-03
• Study Completion: 2014-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prostacyclin	Prostacycline	Treatment with prostacyclin
Isotonic saline	Isotonic saline	Treatment with isotonic saline

Primary Outcome Measures

Name	Time	Method
Change in endothelial biomarkers	Baseline to 6 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Functional haemostasis evaluated by thrombelastography	Baseline to 6 hours postoperatively

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Zealand, Denmark