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

Vasculopathic Injury and Plasma as Endothelial Rescue – OCTAplas trial - VIPER-OCTA trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000452-28-DK

Enrollment

Unknown

Registered

2014-09-02

Start date

2014-11-05

Completion date

Unknown

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients undergoing emergency surgery for thoracic aortic dissections MedDRA version: 17.0 Level: LLT Classification code 10009789 Term: Coagulation factors decreased System Organ Class: 100000004848

Interventions

Trade Name: octaplasLG Pharmaceutical Form: Infusion Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use Product Name: Fresh frozen plasma Pharmaceuti

Eligibility

Sex/Gender

All

Inclusion 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 21 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 21

Exclusion criteria

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 randomised 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).

Design outcomes

Primary

Measure	Time frame
Primary end point(s): • Plasma levels of endothelial markers (Syndecan-1, sTM, sE-selectin, sVE-cadherin);Timepoint(s) of evaluation of this end point: at 24 hours postoperatively, as compared to baseline;Main Objective: To conduct a pilot trial to assess the effects of OctaplasLG® on endothelial integrity, as compared to standard FFP, in a patient population experiencing severe endothelial dysfunction.;Secondary Objective: To assess the effects of OctaplasLG® on acute kidney injury and renal replacement therpy, as compared to standard FFP.	—

Measure

Time frame

Primary end point(s): • Plasma levels of endothelial markers (Syndecan-1, sTM, sE-selectin, sVE-cadherin);Timepoint(s) of evaluation of this end point: at 24 hours postoperatively, as compared to baseline;Main Objective: To conduct a pilot trial to assess the effects of OctaplasLG® on endothelial integrity, as compared to standard FFP, in a patient population experiencing severe endothelial dysfunction.;Secondary Objective: To assess the effects of OctaplasLG® on acute kidney injury and renal replacement therpy, as compared to standard FFP.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary outcome measures: • Plasma levels of endothelial markers (Syndecan-1, 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, see appendix 1 • Renal replacement therapy • Sepsis-Related Organ Failure Assessment (SOFA), worst score during ICU stay, see appendix 2 • 30-day and 90-day mortality • P-CRP, IL-6, P-Catecholamines at 24 hours and 48 hours • Length of stay in ICU and hospital • Severe adverse reactions (SAR) ;Timepoint(s) of evaluation of this end point: Endothelial markers at 48 postoperatively, AKI in the first 7 days, renal replacement therapy during hospitalization, mortality at 30 and 90 days.	—

Measure

Time frame

Secondary end point(s): Secondary outcome measures: • Plasma levels of endothelial markers (Syndecan-1, 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, see appendix 1 • Renal replacement therapy • Sepsis-Related Organ Failure Assessment (SOFA), worst score during ICU stay, see appendix 2 • 30-day and 90-day mortality • P-CRP, IL-6, P-Catecholamines at 24 hours and 48 hours • Length of stay in ICU and hospital • Severe adverse reactions (SAR) ;Timepoint(s) of evaluation of this end point: Endothelial markers at 48 postoperatively, AKI in the first 7 days, renal replacement therapy during hospitalization, mortality at 30 and 90 days.

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Countries

Denmark

Contacts

Public ContactPär I. Johansson

Section for Transfusion Medicine, Capitol Region Blood Bank

per.johansson@regionh.dk4535452030

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026