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Effect of Prostacyclin on Haemostasis in Abdominal Surgery

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01528943
Enrollment
40
Registered
2012-02-08
Start date
2012-03-31
Completion date
2014-01-31
Last updated
2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Keywords

prostacycline, endothel integrity and abdominal surgery

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.

Interventions

DRUGProstacycline

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

DRUGIsotonic saline

same volume as the group that are allocated to prostacycline

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in endothelial biomarkersBaseline to 6 hours postoperatively

Secondary

MeasureTime frame
Functional haemostasis evaluated by thrombelastographyBaseline to 6 hours postoperatively

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026