Vasculopathic Injury and Plasma as Endothelial Rescue - OCTAplas Trial (EudraCT no. 2014-000452-28)

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Effects of OctaplasLG® on endothelial integrity in patients undergoing emergency surgery for thoracic aortic dissections - a randomized, controlled, single-blinded investigator-initiated pilot trial

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Collaborator: Octapharma

Criteria

Inclusion Criteria:

• Patient eligible for emergency surgery on cardiopulmonary bypass pump for a thoracic aortic dissections AND

• Age > 18 years AND

• Consent obtainable from patient or by proxy (independent physicians and/or next of kin)

Exclusion Criteria:

• Documented refusal of blood transfusion OR

• FFP transfusion before randomization OR

• Aortic dissection due to trauma OR

• Treatment with GPIIb/IIIa inhibitors < 24h from screening OR

• Withdrawal from active therapy OR

• Expected to die < 24h OR

• Previously within 30 days included in a randomized trial, if known at the time of enrolment

• Known IgA deficiency with documented antibodies against IgA

• Known hypersensitivity to OctaplasLG®: the active substance, any of the excipients (Sodium citrate dihydrate, Sodium dihydrogenphosphate dihydrate or Glycine) or residues from the manufacturing process (Tri (N-Butyl) Phosphate (TNBP) and Octoxynol (Triton X-100))

• Known severe deficiencies of protein S

• Pregnancy (non-pregnancy confirmed by patient being postmenopausal or having a negative serum-hCG)