Effect of Prostacyclin on Haemostasis in Abdominal Surgery

Rigshospitalet, Denmark40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Surgery

Interventions

ProstacyclineDRUG

Continuous infusion peri -and 6 hours postoperatively of prostacycline 1 ng/kg/min

Isotonic salineDRUG

same volume as the group that are allocated to prostacycline

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rigshospitalet

Copenhagen, Region Sjælland, Denmark

Outcomes

Primary Outcomes

Change in endothelial biomarkers

Time frame: Baseline to 6 hours postoperatively

Secondary Outcomes

Functional haemostasis evaluated by thrombelastography

Time frame: Baseline to 6 hours postoperatively

Data from ClinicalTrials.gov

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