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Tests treatment safety and results for Regional Citrate Anticoagulation (RCA)
Official title Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
ClinicalTrials.gov ID: NCT05399537
What this study is testing
What is Prismocitrate 18?
Prismocitrate 18 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for regional citrate anticoagulation (rca).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 written informed consent form (ICF) per 21 CFR Part 50.55(e)
You likely can't join if
- Patients with a known allergy to citrate or who have ever experienced an adverse reaction associated with citrate products, including patients with a...
- Patients with acute liver failure, defined by the occurrence of encephalopathy and hepatic synthetic dysfunction within 26 weeks of the first...
- Patients with acute-on-chronic liver failure characterized by acute decompensation of cirrhosis and a Child-Pugh Liver Failure Score \>10
- Patients with refractory shock and associated lactic acidosis (lactate \>4 mmol/L)
- Patients with a systemic ionized calcium concentration outside the normal physiologic range (1.0 - 1.3 mmol/L), or outside of the laboratory...
- Female patients of childbearing potential who are pregnant or breastfeeding. (Note: All female patients, who have not undergone a hysterectomy...
See the full eligibility 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 written informed consent form (ICF) per 21 CFR Part 50.55(e)
- Patients with a known allergy to citrate or who have ever experienced an adverse reaction associated with citrate products, including patients with a prior history of citrate toxicity
- Patients with acute liver failure, defined by the occurrence of encephalopathy and hepatic synthetic dysfunction within 26 weeks of the first symptoms of liver disease and without evidence of chronic liver disease
- Patients with acute-on-chronic liver failure characterized by acute decompensation of cirrhosis and a Child-Pugh Liver Failure Score \>10
- Patients with refractory shock and associated lactic acidosis (lactate \>4 mmol/L)
- Patients with a systemic ionized calcium concentration outside the normal physiologic range (1.0 - 1.3 mmol/L), or outside of the laboratory reference range (Note: It is acceptable to provide calcium supplementation or...
- Female patients of childbearing potential who are pregnant or breastfeeding. (Note: All female patients, who have not undergone a hysterectomy, bilateral oophorectomy with or without hysterectomy, or has medically...
- Patients who are currently participating in another treatment clinical study
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Ann Arbor, Michigan, United States
- Springfield, Ohio, United States
- Danville, Pennsylvania, United States
- Hershey, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Charleston, South Carolina, United States
- Memphis, Tennessee, United States
- Dallas, Texas, United States
- McAllen, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; Miami, Florida, United States; Atlanta, Georgia, United States; Ann Arbor, Michigan, United States; Springfield, Ohio, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.