Effect of Prostacyclin on Haemostasis in Abdominal Surgery

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

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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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