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Effect of Prostacyclin on Haemostasis in Abdominal Surgery

Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Abdominal Surgery

Intervention: Prostacycline (Drug); Isotonic saline (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Rigshospitalet, Denmark

Overall contact:
Pär I Johansson, MD, DMSc; MPA, Phone: 4535452030, Email: rh08061@rh.dk

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.

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Change in endothelial biomarkers

Secondary outcome: Functional haemostasis evaluated by thrombelastography

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Pär I Johansson, MD, DMSc; MPA, Phone: 4535452030, Email: rh08061@rh.dk

Rigshospitalet, Copenhagen, Zealand 2100, Denmark; Not yet recruiting
Additional Information

Starting date: March 2012
Last updated: February 7, 2012

Page last updated: August 23, 2015

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