Effect of Prostacyclin on Haemostasis in Abdominal Surgery
This study is not yet open for participant recruitment.
Verified February 2012 by Rigshospitalet, Denmark
Sponsor:
Rigshospitalet, Denmark
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
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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:
- Allergy towards the study medication
- In treatment with platelet ADP receptor inhibitors or heparin (not including thrombosis prophylaxis), Factor Xa inhibitors, trombininhibitors, Vitamin K antagonists
- Autoimmune disease
- Intracranial bleeding within the last 6 months
- Acute coronary syndrome or myocardial infarction within the last 6 months
- Congestive heart disease
- Pregnant or breastfeeding
- Participating in another clinical study within the last 30 days
- Liver cirrhosis
- Need for renal replacement therapy
Contacts and Locations
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:
|
Hemostatics Epoprostenol Tezosentan Coagulants Hematologic Agents Therapeutic Uses |
Pharmacologic Actions Platelet Aggregation Inhibitors Antihypertensive Agents Cardiovascular Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on May 16, 2013