Study Stopped
Study halted due to low recruitment, unrelated to safety or efficacy reasons
Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)
1 other identifier
interventional
34
2 countries
12
Brief Summary
The purpose of this research is to determine if an investigational new drug solution called Prismocitrate 18 lengthens extracorporeal circuit life in patients treated with continuous renal replacement therapy (CRRT). Patients who receive CRRT treatment with Prismocitrate 18 as the anticoagulant will be compared to patients who receive CRRT treatment with no anticoagulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2016
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2016
CompletedFirst Posted
Study publicly available on registry
August 9, 2016
CompletedStudy Start
First participant enrolled
September 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2018
CompletedResults Posted
Study results publicly available
January 5, 2021
CompletedJuly 22, 2025
July 1, 2025
1.6 years
July 29, 2016
November 9, 2020
July 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Occurrence of Selected Prismaflex® System Alarms/Conditions
The point estimate is time point (number of hours of the extracorporeal circuit life of a filter) at which (100-percentile)% filters are still surviving (i.e. number surviving divided by number at risk), based on the Kaplan-Meier method. For example, for the 25th percentile: after 33.18 hours, 75% of filters are still surviving. Given the early termination, this study was not powered to show statistically significant changes in efficacy endpoints. The Prismaflex M150 Set extracorporeal circuit life of filters were intended to be assessed over a maximum of 120 hours (Treatment Period) by duration of time for which each Prismaflex M150 Set could be used continuously over a maximum 72 hour time-period in each patient. The end of the extracorporeal circuit life was defined by the occurrence of one or both of the following Prismaflex® System alarms/conditions if the alarms could not be mitigated: (1) "Warning: Filter Clotted", and/or (2) "Advisory transmembrane pressure (TMP) Too High."
Up to 120 hours post CRRT treatment initiation
Secondary Outcomes (24)
Change From Baseline in Patient Ionized Calcium (iCa) by Hour
Baseline and up to 120 hours post CRRT treatment initiation
Extracorporeal Circuit Ionized Calcium by Hour
Up to 120 hours post CRRT treatment initiation
Delivery of Prescribed CRRT Dose by Day
Up to 120 hours post CRRT treatment initiation
Number of Investigator Site Facilities That Passed Prismocitrate 18 Training Assessment
Prior to study use of Prismocitrate 18
Change From Baseline in Serum Bicarbonate by Hour
Baseline and up to 120 hours post CRRT treatment initiation
- +19 more secondary outcomes
Study Arms (2)
Prismocitrate 18
EXPERIMENTALNo Regional Anticoagulation of CRRT Circuit
ACTIVE COMPARATORInterventions
Modality of CVVHDF
Eligibility Criteria
You may qualify if:
- Patient must be receiving medical care in an intensive care unit (ICU) (e.g., medical ICU, surgical ICU, cardiothoracic ICU, Trauma ICU, Mixed ICU, other).
- Adult patients with AKI or other serious conditions who require treatment with CRRT.
- Patients are expected to remain in the ICU and on CRRT for at least 72 hours after randomization.
- Patients already receiving standard-of-care CRRT must be randomized within 24 hours of initiation of their standard-of-care CRRT.
You may not qualify if:
- Patients requiring systemic anticoagulation with antithrombotic agents for reasons other than CRRT. The exception is patients receiving subcutaneous heparin for deep vein thrombosis prophylaxis according to institutional practice or patients on aspirin may be enrolled.
- Patients in whom citrate anticoagulation is contraindicated such as patients with a known allergy to citrate or who have experienced adverse events associated with citrate products including patients with a prior history of citrate toxicity or patients with uncorrected severe hypocalcemia (whether in the context of current citrate administration or due to the underlying disease state).
- Patients who are not candidates for CRRT.
- Patients who are receiving extracorporeal membrane oxygenation (ECMO) therapy.
- Patients with severe coagulopathy \[i.e., platelets \< 30,000/mm3, international normalized ratio (INR) \> 2, partial thromboplastin time (PTT) \> 50 seconds\] including severe thrombocytopenia (platelets \< 30,000/mm3), HIT (heparin induced thrombocytopenia), ITP (idiopathic thrombocytopenia purpura), and TTP (thrombotic thrombocytopenia purpura) should not be enrolled in the trial.
- Patients with fulminant acute liver failure or acute on chronic liver failure as documented by a Child-Pugh Liver Failure Score \> 10.
- Patients with refractory shock associated persistent, worsening with lactic acidosis (lactate \> 4 mmol/L). However, patients with improving subsequent serum lactate levels may be enrolled.
- Patients unlikely to survive at least 72 hours.
- Female patients who are pregnant, lactating, or planning to become pregnant during the study period.
- Patients who are currently participating in another interventional clinical study.
- Patients with a medical condition that may interfere with the study objectives.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vantive Health LLClead
- Baxter Healthcare Corporationcollaborator
Study Sites (12)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Arizona
Tucson, Arizona, 85724, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Kentucky
Lexington, Kentucky, 40526, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Beth Israel Deaconess (Harvard)
Boston, Massachusetts, 02215, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Alberta Hospital
Edmonton, Alberta, T6G2B7, Canada
Related Publications (1)
Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.
PMID: 33314078DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated as it was proven to be extremely difficult to enroll patients. The study termination decision was unrelated to safety or efficacy. Given the early termination, this study was not powered to show statistically significant changes in efficacy endpoints.
Results Point of Contact
- Title
- Global CORP Clinical Trials Disclosure
- Organization
- Vantive
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2016
First Posted
August 9, 2016
Study Start
September 27, 2016
Primary Completion
May 12, 2018
Study Completion
May 12, 2018
Last Updated
July 22, 2025
Results First Posted
January 5, 2021
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share