EudraCT: 2014‐000452‐28.

Study name	'Vasculopathic Injury and Plasma as Endothelial Rescue ‐ OCTAplas Trial (VIPER‐OCTA)'
Methods	Type of study: single‐centre randomised controlled trial Follow‐up until: 90 days postoperatively
Participants	Inclusion: 1. Patient undergoing emergency surgery with cardiopulmonary bypass pump for a thoracic aortic dissection 2. Over 18 years age 3. Consent obtainable from patient or by proxy (independent physician and/or next of kin) Exclusion: 1. Documented refusal of blood transfusion 2. FFP transfusion before randomisation 3. Aortic dissection due to trauma 4. Treatment with GPIIb/IIIa inhibitors less than 24 hours from screening 5. Withdrawal from active therapy 6. Expected to die less than 24 hours from screening 7. Previously within 30 days included in a randomised trial, if known at the time of enrolment 8. Known IgA deficiency with documented antibodies against IgA 9. Known hypersensitivity to OctaplasLG®: the active substance, any of the excipients (sodium citrate dihydrate, sodium dihydrogen phosphate dihydrate or glycine) or residues from the manufacturing process (Tri (N‐Butyl) Phosphate (TNBP) and Octoxynol (Triton X‐100)) 10. Known severe deficiencies of protein S 11. Pregnancy (non‐pregnancy confirmed by patient being postmenopausal or having a negative serum‐hCG)
Interventions	Intervention arm: OctaplasLG Comparator arm: Fresh frozen plasma
Outcomes	Primary outcome: Plasma levels of endothelial markers (Syndecan‐1, soluble thrombomodulin, sE‐selectin, sVE‐cadherin) at 24 hours postoperatively Other outcomes: 1. Plasma levels of endothelial markers (Syndecan‐1, soluble thrombomodulin, sE‐selectin, sVE‐cadherin) at 48 hours postoperatively 2. Acute kidney injury according to RIFLE criteria in the first 7 postoperative days 3. Renal replacement therapy in the first 7 postoperative days 4. Sepsis‐related organ failure assessment: worst score in the first 7 postoperative days 5. Mortality at 30 days and 90 days postoperatively 6. C‐reactive protein, interleukin‐6, catecholamines at 24 hours and 48 hours postoperatively 7. Length of stay in ICU and hospital assessed at 30 days and 90 days 8. Severe adverse reactions in the first 30 postoperative days 9. Transfusion‐associated acute lung injury in the first 30 postoperative days 10. Transfusion‐associated circulatory overload in the first 30 postoperative days
Starting date	November 2014
Contact information	Principal investigators: Jakob Stensballe (stensballe@rh.dk) and Pär I Johansson (per.johansson@regionh.dk)
Notes	—

CPB: cardiopulmonary bypass
FFP: fresh frozen plasma
ICU: intensive care unit