Efficacy and safety of octaplasLG® administration vs. crystalloids (standard) in patients
with septic shock - a randomized, controlled, open-label investigator-initiated pilot trial.
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Full eligibility criteria for NCT02875236
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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)
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
All locations for NCT02875236
Intensive Care Unit Bispebjerg Hospital
Copenhagen, Denmark, 2400
View full eligibility
Tris trial is registered with FDA with number: NCT02875236. The sponsor of the trial is Rigshospitalet, Denmark and it is looking for 5 volunteers for the current phase.
Official trial title: Efficacy and Safety of OctaplasLG Administration vs. Crystalloids (Standard) in Patients With Septic Shock - a Randomized, Controlled, Open-label Investigator-initiated Pilot Trial
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