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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2017
• Main ID: NCT02253082
• Date of registration: 25/09/2014
• Prospective Registration: Yes
• Primary sponsor: Rigshospitalet, Denmark
• Public title: Vasculopathic Injury and Plasma as Endothelial Rescue - OCTAplas Trial (EudraCT no. 2014-000452-28) VIPER-OCTA
• Scientific title: Effects of OctaplasLG® on Endothelial Integrity in Patients Undergoing Emergency Surgery for Thoracic Aortic Dissections - a Randomized, Controlled, Single-blinded Investigator-initiated Pilot Trial
• Date of first enrolment: November 2014
• Target sample size: 44
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02253082
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Denmark

Contacts

• Name: Jakob Stensballe, MD, PhD
• Affiliation: Rigshospitalet, Denmark

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Aortic Aneurysm, Thoracic

Endothelial Dysfunction

Intervention(s)

Biological: Fresh frozen plasma

Drug: OctaplasLG®

Primary Outcome(s)

Plasma levels of endothelial markers (Syndecan-1, sTM, sE-selectin, sVE-cadherin) [Time Frame: At 24 hours after arrival in ICU for postoperative care, as compared to baseline]

Secondary Outcome(s)

Sepsis-Related Organ Failure Assessment (SOFA) [Time Frame: Worst score In the first 7 postoperative days]

Severe adverse reactions [Time Frame: In the first 30 postoperative days]

Renal replacement therapy [Time Frame: In the first 7 postoperative days]

P-Creactive protein (CRP), Interleukin-6 (IL-6), P-Catecholamines [Time Frame: At 24 hours and 48 hours]

Mortality [Time Frame: 30-day and 90-day]

Acute Kidney Injury (AKI) according to RIFLE Criteria [Time Frame: In the first 7 postoperative days]

Length of stay in ICU and hospital [Time Frame: Days, assessed at 30-days and 90-days]

Plasma levels of endothelial markers (Syndecan-1, soluble thrombomodulin (sTM), sE-selectin, sVE-cadherin) [Time Frame: At 48 hours postoperatively, as compared to baseline]

Secondary ID(s)

VIPER-OCTA

H-3-2014-018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Octapharma