Effect of Prostacyclin on Haemostasis in Abdominal Surgery

March 9, 2021 updated by: Pär Johansson, Rigshospitalet, Denmark

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Zealand
      • Copenhagen, Zealand, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prostacyclin
Treatment with prostacyclin
Drug: Prostacycline
Continuous infusion peri -and 6 hours postoperatively of prostacycline 1 ng/kg/min
Placebo Comparator: Isotonic saline
Treatment with isotonic saline
Drug: Isotonic saline
same volume as the group that are allocated to prostacycline

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Pär Johansson I Johansson, MD DMSc MPA, Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

February 5, 2012

First Submitted That Met QC Criteria

February 7, 2012

First Posted (Estimate)

February 8, 2012

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ET Abdominal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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