Capillary leakage secondary to major surgical stress
Conditions
Interventions
Trade Name: Ilomedin
Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the pla
Sponsors
Blodbanken, Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 Endothelial activation markers are: soluble thrombomoduline soluble E-selectin Syndecan-1;Timepoint(s) of evaluation of this end point: Baseline (immediately prior to start of surgery) End of surgery Discharge from postoperative ward or 24 hours postoperatively, which ever comes first | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Degree of coagulopathy at the end of surgery, as evaluated by TEG 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 Discharge from postoperative ward or 24 hours postoperatively, whichever comes first | — |
Countries
Denmark
Contacts
Public ContactDr. Pär Johansson
Blodbanken, Rigshospitalet
Outcome results
None listed