The effect of prostacyclin on haemostasis as evaluated by thrombelastography and endothelial markers in patients undergoing major abdominal surgery. A pilot study.

Conditions: Capillary leakage secondary to major surgical stress
Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

Registration Number: EUCTR2011-005234-19-DK

Lead Sponsor: Blodbanken, Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Men and women above 18 years old
2.Undergpoing Whipple surgery or liver resection
3.Able and willing to give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

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 replacememt therapy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of continues prostacyclin infusion in patient undergoing major abdominal surgery. Main endpoint is change in concentration of endothelial activation markers from baseline to discharger from postoperative ward or 24 hours postoperatively, whichever comes first.;Secondary Objective: Degree of coagulopathy as evaluated by TEG at the end of surgery<br>Number of blood transfusions from start of surgery to discharge from the postoperative ward;Primary end point(s): Levels of endothelial activation markers in the circulating blood at discharge from the postoperative ward or 24 hours postoperatively, whichever comes first compared to baseline<br>Endothelial activation markers are:<br>soluble thrombomoduline<br>soluble E-selectin<br>Syndecan-1;Timepoint(s) of evaluation of this end point: Baseline (immediately prior to start of surgery)<br>End of surgery<br>Discharge from postoperative ward or 24 hours postoperatively, which ever comes first

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Degree of coagulopathy at the end of surgery, as evaluated by TEG<br>Number of blood transfusions at discharge from postoperative ward or 24 hours postoperatively, whichever comes first;Timepoint(s) of evaluation of this end point: End of surgery<br>Discharge from postoperative ward or 24 hours postoperatively, whichever comes first