Effect of Prostacyclin on Haemostasis in Abdominal Surgery

Surgery Clinical Trial

Official title:

The Effect of Prostacyclin on Haemostasis as Evaluated by Thrombelastography and Endothelial Markers in Patients Undergoing Major Abdominal Surgery. A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528943
• Other study ID #: ET Abdominal
• Status: Completed
• Phase: Phase 1
• Start date: March 2012
• Est. completion date: January 2014

Study information

• Verified date: March 2021
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

Drug:
• Prostacycline
Continuous infusion peri -and 6 hours postoperatively of prostacycline 1 ng/kg/min
• Isotonic saline
same volume as the group that are allocated to prostacycline

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Zealand

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in endothelial biomarkers		Baseline to 6 hours postoperatively
Secondary	Functional haemostasis evaluated by thrombelastography		Baseline to 6 hours postoperatively