NCT04174989 - Clinical Investigation of Safety and Performance of a Medical Device (ClearPlasma) for the Treatment of Patients With Acute Upper Gastrointestinal Hemorrhage. | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 24, 2020

Primary Completion Date

June 30, 2022

Study Completion Date

November 13, 2022

Conditions

Acute Upper Gastrointestinal HemorrhageAcute Upper Gastrointestinal Bleeding

Interventions

OTHER

Plasma treated with ClearPlasma (Extra-corporeal plasma filtration device)

ClearPlasma is designed to specifically extract plasminogen, a protein that drives fibrinolysis, from up to 250 mL of plasma. ClearPlasma is a non-pyrogenic, sterile, single-use medical device that is indicated for use in conditions where massive bleeding situations exist.

OTHER

Regular fresh-frozen plasma (not treated)

Trial Locations (8)

41124

S.C. di Anestesia e Rianimazione 1, Azienda Ospedaliera Universitaria Policlinico di Modena, Modena

49100

Department of Surgery, Rabin Medical Center, Petah Tikva

50005

Charles University Teaching Hospital, Hradec Králové

70852

University Hospital Ostrava, Ostrava

77900

University Hospital in Olomouc, Olomouc

4428164

Department of Surgery B, Meir Medical Center Kfar Saba, Kfar Saba

5822012

Wolfson Medical center, Holon

00168

Area Medicina D'Urgenza e Pronto Soccorso, Fondazione Policlinico Universitario A. Gemelli, Roma