Clinical Investigation of Safety and Performance of a Medical Device (ClearPlasma) for the Treatm… (NCT04174989) | Clinical Trial Compass
CompletedNot Applicable
Clinical Investigation of Safety and Performance of a Medical Device (ClearPlasma) for the Treatment of Patients With Acute Upper Gastrointestinal Hemorrhage.
Czechia, Israel53 participantsStarted 2020-10-24
Plain-language summary
Pre-market, multi-center, international, double-blind, randomized, controlled, prospective, first-in-human clinical investigation of a Class IIb Investigational Medical Device, in which Patients presenting with acute upper gastrointestinal hemorrhage (AUGIH) and due to undergo a plasma transfusion, will be randomized to receive a one-time infusion (up to 8 hours) of up to two 250 mL units of plasminogen-depleted plasma (PDP) or fresh-frozen plasma (FFP).
In case of transfusions needing more than two units, the third unit and above will consist in regular plasma for both treatment groups. Patients will be continuously monitored for 8 hours following the transfusion, and will be assessed between 8-12 hours after plasma transfusion or the following morning (the earlier of the two options), between 24-48 hours after plasma transfusion or at discharge (the earlier of the two options) and after 30+/-3 days after transfusion.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female Patients.
✓. Patients aged ≥ 18 and ≤ 80 years old.
✓. Patients presenting with acute upper gastrointestinal hemorrhage (\> 0.5 L), diagnosed by presence of blood in gastric lavage, hematemesis or melena within no longer than 24 h before enrolment.
✓. Patients presenting with acute upper gastrointestinal hemorrhage (\< 24 h) for which fresh frozen plasma (FFP) has been ordered.
✓. Patients understanding the nature of the study and providing their informed consent to participation.
✓. Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol.
Exclusion criteria
✕. Patients who underwent a plasma infusion in the 30 days before enrolment.
✕. Patients in a life-threatening condition at the time of enrolment.
✕. Patient on anticoagulant therapy at the time of enrolment.
What they're measuring
1
Safety Profile in Patients treated with PDP versus FFP.
Timeframe: Entire Study Period (up to 1 month per patient).