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Effect of Prostacyclin on Haemostasis in Abdominal Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Per Johansson, Rigshospitalet, Denmark.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01528943
First Posted: February 8, 2012
Last Update Posted: February 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Per Johansson, Rigshospitalet, Denmark
  Purpose
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.

Condition Intervention Phase
Abdominal Surgery Drug: Prostacycline Drug: Isotonic saline Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Prostacyclin on Haemostasis as Evaluated by Thrombelastography and Endothelial Markers in Patients Undergoing Major Abdominal Surgery. A Pilot Study

Resource links provided by NLM:


Further study details as provided by Per Johansson, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Change in endothelial biomarkers [ Time Frame: Baseline to 6 hours postoperatively ]

Secondary Outcome Measures:
  • Functional haemostasis evaluated by thrombelastography [ Time Frame: Baseline to 6 hours postoperatively ]

Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prostacyclin Drug: Prostacycline
Continuous infusion peri -and 6 hours postoperatively of prostacycline 1 ng/kg/min
No Intervention: Isotonic saline Drug: Isotonic saline
same volume as the group that are allocated to prostacycline

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528943


Contacts
Contact: Pär I Johansson, MD, DMSc; MPA 4535452030 rh08061@rh.dk

Locations
Denmark
Rigshospitalet Not yet recruiting
Copenhagen, Zealand, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
  More Information

Responsible Party: Per Johansson, Medical Director, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01528943     History of Changes
Other Study ID Numbers: ET Abdominal
First Submitted: February 5, 2012
First Posted: February 8, 2012
Last Update Posted: February 8, 2012
Last Verified: February 2012

Keywords provided by Per Johansson, Rigshospitalet, Denmark:
To evaluate the effect of prostacycline on endothelial integrity during major abdominal surgery

Additional relevant MeSH terms:
Hemostatics
Epoprostenol
Tezosentan
Coagulants
Antihypertensive Agents
Platelet Aggregation Inhibitors
Vasodilator Agents