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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02253082
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : December 20, 2016
Information provided by (Responsible Party):
Jakob Stensballe, MD, PhD, Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Thoracic Endothelial Dysfunction Drug: OctaplasLG® Biological: Fresh frozen plasma Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Octaplas

Arm Intervention/treatment
Active Comparator: OctaplasLG®
replacement to bleeding
Drug: OctaplasLG®
OctaplasLG® is an industrial donor plasma product pooled from approximately 400 single donor units. It possess' unique features when compared to standard FFP, such as having standardized concentrations of natural pro- and anti-coagulation factors, standardized volume and as being pathogen free. Very importantly, the manufacturing method of OctaplasLG® removes immune complexes and cells in several steps of microfiltration in addition to viral, bacterial and prion pathogen inactivation.
Other Name: Octaplas

Placebo Comparator: Standard fresh frozen plasma
replacement to bleeding
Biological: Fresh frozen plasma
Standard FFP from the Blood Bank
Other Name: FFP

Primary Outcome Measures :
  1. 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 Measures :
  1. Plasma levels of endothelial markers (Syndecan-1, soluble thrombomodulin (sTM), sE-selectin, sVE-cadherin) [ Time Frame: At 48 hours postoperatively, as compared to baseline ]
  2. Acute Kidney Injury (AKI) according to RIFLE Criteria [ Time Frame: In the first 7 postoperative days ]
  3. Renal replacement therapy [ Time Frame: In the first 7 postoperative days ]
  4. Sepsis-Related Organ Failure Assessment (SOFA) [ Time Frame: Worst score In the first 7 postoperative days ]
  5. Mortality [ Time Frame: 30-day and 90-day ]
  6. P-Creactive protein (CRP), Interleukin-6 (IL-6), P-Catecholamines [ Time Frame: At 24 hours and 48 hours ]
  7. Length of stay in ICU and hospital [ Time Frame: Days, assessed at 30-days and 90-days ]
  8. Severe adverse reactions [ Time Frame: In the first 30 postoperative days ]

Other Outcome Measures:
  1. Transfusion associated acute lung injury (TRALI) [ Time Frame: In the first 30 postoperative days ]
  2. Transfusion associated circulatory overload (TACO) [ Time Frame: In the first 30 postoperative days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02253082

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Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Rigshospitalet, Denmark
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Principal Investigator: Jakob Stensballe, MD, PhD Rigshospitalet, Denmark

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jakob Stensballe, MD, PhD, MD, PhD, Consultant, Rigshospitalet, Denmark Identifier: NCT02253082     History of Changes
Other Study ID Numbers: VIPER-OCTA
H-3-2014-018 ( Other Identifier: Regional Health Research Ethics Committee )
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases