Status:
COMPLETED
Vasculopathic Injury and Plasma as Endothelial Rescue - OCTAplas Trial (EudraCT no. 2014-000452-28)
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Octapharma
Conditions:
Aortic Aneurysm, Thoracic
Endothelial Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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
Detailed Description
Trial Name: VIPER-OCTA trial - Vasculopathic Injury and Plasma as Endothelial Rescue - OCTAplas trial Background * Patients operated for thoracic aortic dissections in deep hypothermic circulatory a...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT02253082
Start Date
November 1 2014
End Date
December 1 2016
Last Update
December 20 2016
Active Locations (1)
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1
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark, DK-2100