Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT

Recruiting Phase 3 Interventional Study
Regional Citrate Anticoagulation (RCA) Continuous Renal Replacement Therapy (CRRT) Acute Kidney Injury (AKI)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Vantive Health LLC · Industry
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About This Trial
Prismocitrate 18 is a continuous renal replacement therapy (CRRT) solution to be used as a renal replacement solution and as an anticoagulant to prevent blood clotting in the extracorporeal circuit. The delivery of CRRT therapy is provided by the PrisMax System which includes regional citrate anticoagulation (RCA) software to facilitate citrate and calcium compensation prescription. The objective…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patients must be ≥18 years of age * Patients who are candidates for CRRT * Patients expected to survive for at least 24 hours * Patients with a contraindication to heparin or an increased risk of hemorrhage * Patient and/or legally-authorized representative has signed a writte…
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Global CORP Clinical Trials Disclosure

+1 2249484283

Global.CORP.ClinicalTrialsDisclosure@vantive.com

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