Effect of Prostacyclin on Haemostasis in Abdominal Surgery

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2013

Interventions

  • Drug: Prostacycline
    • Continuous infusion peri -and 6 hours postoperatively of prostacycline 1 ng/kg/min
  • Drug: Isotonic saline
    • same volume as the group that are allocated to prostacycline

Arms, Groups and Cohorts

  • Experimental: Prostacyclin
    • Treatment with prostacyclin
  • Placebo Comparator: Isotonic saline
    • Treatment with isotonic saline

Clinical Trial Outcome Measures

Primary Measures

  • Change in endothelial biomarkers
    • Time Frame: Baseline to 6 hours postoperatively

Secondary Measures

  • Functional haemostasis evaluated by thrombelastography
    • Time Frame: Baseline to 6 hours postoperatively

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pär Johansson, Medical Director – Rigshospitalet, Denmark
  • Overall Official(s)
    • Pär Johansson I Johansson, MD DMSc MPA, Principal Investigator, Professor

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