Evaluation of ClearPlasma in Patients With Upper Gastrointestinal Bleeding. (NCT06761430) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of ClearPlasma in Patients With Upper Gastrointestinal Bleeding.
Italy7 participantsStarted 2019-12-23
Plain-language summary
Upper gastrointestinal hemorrhage (UGIH) is one of the most common gastrointestinal emergencies, and is associated with significant morbidity and mortality. Plas-Free aims to evaluate ClearPlasma safety in patients with UGIH.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* 1\. Patients aged ≥ 18 and ≤ 80 years old. 2. 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.
3\. Patients presenting with acute upper gastrointestinal hemorrhage (\< 24 h) for which fresh frozen plasma (FFP) has been ordered.
4\. Patients understanding the nature of the study and providing their informed consent to participation.
5\. Patients willing and able to attend the follow-up visits and procedures foreseen by the study protocol.
Exclusion Criteria:
Patients who underwent a plasma infusion in the 30 days before enrolment. 2. Patients in a life-threatening condition at the time of enrolment (i.e. heart attack).
3\. Patients who are hemodynamically unstable and required pressor administration at the time of enrolment (i.e. with hypovolemic shock) 4. Patients with known renal failure (creatinine clearance \< 30 mL/min) at the time of enrolment.
5\. Patients suffering from Hemophilia A or B. 6. Patients suffering from venous and arterial thromboembolic events within 3 months before the enrolment.
7\. Patients with increased risk of blood clotting, according to Investigator's judgement.
8\. Patients with fluid accumulation in the brain at the time of enrolment. 9. Patients with retinal thrombosis at the time of enrolment. 10. Patients with measured body weight \< 45 kg at the time of enrolment…