Effect of Prostacyclin on Haemostasis in Abdominal Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Rigshospitalet, Denmark.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Per Johansson, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01528943
First received: February 5, 2012
Last updated: February 7, 2012
Last verified: February 2012
  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: 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 Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Change in endothelial biomarkers [ Time Frame: Baseline to 6 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional haemostasis evaluated by thrombelastography [ Time Frame: Baseline to 6 hours postoperatively ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Per Johansson, Medical Director, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01528943     History of Changes
Other Study ID Numbers: ET Abdominal
Study First Received: February 5, 2012
Last Updated: February 7, 2012
Health Authority: Denmark: Danish Medicines Agency

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

Additional relevant MeSH terms:
Tezosentan
Epoprostenol
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on October 02, 2014