40
Participants
Start Date
July 12, 2024
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2026
Prismocitrate 18
Prismocitrate 18 solution (investigational drug) will be used in pre-dilution mode only; the rate of administration depends on the targeted citrate dose and the prescribed flow rate. The pre-filter infusion rate of Prismocitrate 18 solution will be indexed to the blood flow rate (BFR) to achieve a target blood citrate concentration of 3 mmol/L of blood. The flow rate for the anticoagulation of the extracorporeal circuit will be titrated to achieve a post-filter concentration of iCa of 0.25 to 0.35 mmol/L.
PrisMax System Version 3.x with calcium line accessory
The RCA software on PrisMax System Version 3.x with calcium line accessory (investigational device) will be enabled to carefully guide the health practitioner for citrate dosing and calcium compensation.
RECRUITING
VA Pittsburgh Healthcare System, Pittsburgh
WITHDRAWN
Penn State Hershey Medical Center, Hershey
NOT_YET_RECRUITING
Geisinger Medical Center, Danville
NOT_YET_RECRUITING
Medical University of South Carolina (MUSC), Charleston
NOT_YET_RECRUITING
Emory University, Atlanta
RECRUITING
Lt. Col. Luke Weathers, Jr. VA Medical Center, Memphis
RECRUITING
Bon Secours Mercy Health-Springfield Regional Medical Center, Springfield
NOT_YET_RECRUITING
University of Michigan, Ann Arbor
NOT_YET_RECRUITING
Methodist Dallas Medical Center, Dallas
RECRUITING
Gamma Medical Research, Inc / McAllen Medical Center, McAllen
RECRUITING
University of Southern California (USC) / Keck Hospital, Los Angeles
NOT_YET_RECRUITING
University of California Los Angeles, Los Angeles
NOT_YET_RECRUITING
University of Alabama at Birmingham/UAB, Birmingham
Baxter Healthcare Corporation
INDUSTRY
Vantive Health LLC
INDUSTRY