Last reviewed · How we verify
NCT04174989
Clinical Investigation of Safety and Performance of a Medical Device (ClearPlasma) for the Treatment of Patients With Acute Upper Gastrointestinal Hemorrhage.
NA trial testing Plasma treated with ClearPlasma (Extra-corporeal plasma filtration device) in Acute Upper Gastrointestinal Hemorrhage in 53 participants. Completed in 13 November 2022.
30 June 2022
Quick facts
| Lead sponsor | PlasFree Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 53 |
| Start date | 24 October 2020 |
| Primary completion | 30 June 2022 |
| Estimated completion | 13 November 2022 |
| Sites | 8 locations across Italy, Israel, Czechia |
Drugs / interventions tested
- Plasma treated with ClearPlasma (Extra-corporeal plasma filtration device)
- Regular fresh-frozen plasma (not treated)
Conditions studied
- Acute Upper Gastrointestinal Hemorrhage — all drugs for Acute Upper Gastrointestinal Hemorrhage →
- Acute Upper Gastrointestinal Bleeding — all drugs for Acute Upper Gastrointestinal Bleeding →
Sponsor
PlasFree Ltd.
Who can join
18 and older, any sex, with Acute Upper Gastrointestinal Hemorrhage or Acute Upper Gastrointestinal Bleeding. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04174989
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Upper Gastrointestinal Hemorrhage
Currently open trials in the same condition.
- NCT04786743 — Timing of Endoscopic Intervention for Acute Variceal Hemorrhage: an RCT · NA · recruiting
Other PlasFree Ltd. trials
Trials by the same sponsor.
- NCT05542277 — A Pre-market, Multi-center, International, Double-blind, Randomized, Two-arms, Controlled, Prospective Clinical Investig · NA · terminated
- NCT06761430 — Evaluation of ClearPlasma in Patients With Upper Gastrointestinal Bleeding. · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04174989 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by PlasFree Ltd.
- Last refreshed: 15 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04174989.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing