Endothelial Dysfunction Clinical Trial
— VIPER-OCTAOfficial 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
Effects of OctaplasLG® on endothelial integrity in patients undergoing emergency surgery for thoracic aortic dissections - a randomized, controlled, single-blinded investigator-initiated pilot trial
Status | Completed |
Enrollment | 44 |
Est. completion date | December 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet, Copenhagen University Hospital | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Octapharma |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Transfusion associated acute lung injury (TRALI) | In the first 30 postoperative days | Yes | |
Other | Transfusion associated circulatory overload (TACO) | In the first 30 postoperative days | Yes | |
Primary | 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 | No | |
Secondary | Plasma levels of endothelial markers (Syndecan-1, soluble thrombomodulin (sTM), sE-selectin, sVE-cadherin) | At 48 hours postoperatively, as compared to baseline | No | |
Secondary | Acute Kidney Injury (AKI) according to RIFLE Criteria | In the first 7 postoperative days | No | |
Secondary | Renal replacement therapy | In the first 7 postoperative days | No | |
Secondary | Sepsis-Related Organ Failure Assessment (SOFA) | Worst score In the first 7 postoperative days | No | |
Secondary | Mortality | 30-day and 90-day | No | |
Secondary | P-Creactive protein (CRP), Interleukin-6 (IL-6), P-Catecholamines | At 24 hours and 48 hours | No | |
Secondary | Length of stay in ICU and hospital | Days, assessed at 30-days and 90-days | No | |
Secondary | Severe adverse reactions | In the first 30 postoperative days | Yes |
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