E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Capillary leakage secondary to major surgical stress |
|
E.1.1.1 | Medical condition in easily understood language |
Breakdown of vascular integrity due to surgical stress |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Symptoms and general pathology [C23] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | 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 |
|
E.5.1.1 | 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 |
|
E.5.2 | 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 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of surgery
Discharge from postoperative ward or 24 hours postoperatively, whichever comes first |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last patient included in the trial being discharged from the postoperative ward |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |