Effect of Prostacyclin on Haemostasis in Abdominal Surgery

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Rigshospitalet

Status and phase

Completed
Phase 1

Conditions

Surgery

Treatments

Drug: Isotonic saline
Drug: Prostacycline

Study type

Interventional

Funder types

Other

Identifiers

NCT01528943
ET Abdominal

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Men and women above 18 years old
  • Undergoing Whipple surgery or liver resection
  • Able and willing to give informed consent

Exclusion criteria

  • Allergy towards the study medication
  • In treatment with platelet ADP receptor inhibitors or heparin (not including thrombosis prophylaxis), Factor Xa inhibitors, trombininhibitors, Vitamin K antagonists
  • Autoimmune disease
  • Intracranial bleeding within the last 6 months
  • Acute coronary syndrome or myocardial infarction within the last 6 months
  • Congestive heart disease
  • Pregnant or breastfeeding
  • Participating in another clinical study within the last 30 days
  • Liver cirrhosis
  • Need for renal replacement therapy

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups, including a placebo group

Prostacyclin
Experimental group
Description:
Treatment with prostacyclin
Treatment:
Drug: Prostacycline
Isotonic saline
Placebo Comparator group
Description:
Treatment with isotonic saline
Treatment:
Drug: Isotonic saline

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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