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Effect of Prostacyclin on Haemostasis in Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT01528943
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Pär Johansson, Rigshospitalet, Denmark

Brief Summary:
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 or disease Intervention/treatment Phase
Surgery Drug: Prostacycline Drug: Isotonic saline Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : March 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prostacyclin Drug: Prostacycline
Continuous infusion peri -and 6 hours postoperatively of prostacycline 1 ng/kg/min

Placebo Comparator: Isotonic saline Drug: Isotonic saline
same volume as the group that are allocated to prostacycline




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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


Locations
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Denmark
Rigshospitalet
Copenhagen, Zealand, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Pär Johansson I Johansson, MD DMSc MPA Professor

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Responsible Party: Pär Johansson, Medical Director, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01528943     History of Changes
Other Study ID Numbers: ET Abdominal
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Keywords provided by Pär Johansson, Rigshospitalet, Denmark:
prostacycline, endothel integrity and abdominal surgery
Additional relevant MeSH terms:
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Epoprostenol
Tezosentan
Hemostatics
Coagulants
Antihypertensive Agents
Platelet Aggregation Inhibitors
Vasodilator Agents