NCT02253082

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 20, 2016

Status Verified

December 1, 2016

Enrollment Period

1.8 years

First QC Date

September 25, 2014

Last Update Submit

December 19, 2016

Conditions

Aortic Aneurysm, ThoracicEndothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Plasma levels of endothelial markers (Syndecan-1, sTM, sE-selectin, sVE-cadherin)

    At 24 hours after arrival in ICU for postoperative care, as compared to baseline

Secondary Outcomes (8)

  • Plasma levels of endothelial markers (Syndecan-1, soluble thrombomodulin (sTM), sE-selectin, sVE-cadherin)

    At 48 hours postoperatively, as compared to baseline

  • Acute Kidney Injury (AKI) according to RIFLE Criteria

    In the first 7 postoperative days

  • Renal replacement therapy

    In the first 7 postoperative days

  • Sepsis-Related Organ Failure Assessment (SOFA)

    Worst score In the first 7 postoperative days

  • Mortality

    30-day and 90-day

  • +3 more secondary outcomes

Other Outcomes (2)

  • Transfusion associated acute lung injury (TRALI)

    In the first 30 postoperative days

  • Transfusion associated circulatory overload (TACO)

    In the first 30 postoperative days

Study Arms (2)

OctaplasLG®

ACTIVE COMPARATOR

replacement to bleeding

Drug: OctaplasLG®

Standard fresh frozen plasma

PLACEBO COMPARATOR

replacement to bleeding

Biological: Fresh frozen plasma

Interventions

OctaplasLG®DRUG

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.

Also known as: Octaplas
OctaplasLG®
Fresh frozen plasmaBIOLOGICAL

Standard FFP from the Blood Bank

Also known as: FFP
Standard fresh frozen plasma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, Copenhagen University Hospital

Copenhagen, DK-2100, Denmark

Location

Related Publications (1)

  • Stensballe J, Ulrich AG, Nilsson JC, Henriksen HH, Olsen PS, Ostrowski SR, Johansson PI. Resuscitation of Endotheliopathy and Bleeding in Thoracic Aortic Dissections: The VIPER-OCTA Randomized Clinical Pilot Trial. Anesth Analg. 2018 Oct;127(4):920-927. doi: 10.1213/ANE.0000000000003545.

    PMID: 29863610DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Jakob Stensballe, MD, PhD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Consultant

Study Record Dates

First Submitted

September 25, 2014

First Posted

October 1, 2014

Study Start

November 1, 2014

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

December 20, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)