Vasculopathic Injury and Plasma as Endothelial Rescue in Septic Shock Trial. VIPER-Sepsis (EudraCT no. 2016-000707-81)

• Status: Terminated
• Trial end date: 2016-11-08
• Target enrollment: 0
• Participant gender: All

Summary

Efficacy and safety of octaplasLG® administration vs. crystalloids (standard) in patients with septic shock - a randomized, controlled, open-label investigator-initiated pilot trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Collaborator: Octapharma

Criteria

Inclusion Criteria:

• Adult intensive care patients AND

• Septic shock requiring infusion of vasopressor/inotropic agents to maintain blood pressure as defined in international guidelines AND

• Consent obtainable from patient or by proxy (independent physicians and/or next of kin)

Exclusion Criteria:

• Documented refusal of blood transfusion OR

• Treatment with GPIIb/IIIa inhibitors < 24h from screening OR

• Withdrawal from active therapy OR

• Previously within 30 days included in a randomised trial, if known at the time of enrolment OR

• Known Immunoglobulin A deficiency with documented antibodies against Immunoglobulin A OR

• 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)) OR

• Known severe deficiencies of protein S OR

• Pregnancy (non-pregnancy confirmed by patient being postmenopausal or having a negative urine-hCG) OR

• Severe cirrhotic hepatic failure with expected need for treatment with terlipressin