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Regional Citrate Anticoagulation (RCA)Phase 3NCT02860130

Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)

A Phase 3 study testing Prismocitrate 18 and No Anticoagulation in people with Regional Citrate Anticoagulation (RCA) and Continuous Renal Replacement Therapy (CRRT), run by Vantive Health LLC at 12 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Prismocitrate 18 and No Anticoagulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
12 sitesin 2 countries
Study dates
27 Sep 2016to 12 May 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

United States11 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Beth Israel Deaconess (Harvard)

    Boston, Massachusetts, 02215

  • Northwestern University

    Chicago, Illinois, 60611

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of Kentucky

    Lexington, Kentucky, 40526

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • University of Arizona

    Tucson, Arizona, 85724

Other trials in United States

Canada1 site

  • University of Alberta Hospital

    Edmonton, Alberta, T6G2B7

Other trials in Canada

About this study

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.

Being tested
Prismocitrate 18, No Anticoagulation
Keywords
Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT), Acute Kidney Injury
Medical subject headings
Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prismocitrate 18Drug

    Also called Regional Citrate Anticoagulation (RCA)

    Modality of CVVHDF

  • No AnticoagulationOther

    Modality of CVVHDF

Study groups in NCT02860130
Study groupRoleWhat they receive
Prismocitrate 18ExperimentalNot described
Receives: Drug: Prismocitrate 18
No Regional Anticoagulation of CRRT CircuitActive comparatorNot described
Receives: Other: No Anticoagulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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."

    Measured: Up to 120 hours post CRRT treatment initiation

Secondary outcomes (24)

  1. Change From Baseline in Patient Ionized Calcium (iCa) by Hour

    Systemic blood iCa concentrations

    Measured: Baseline and up to 120 hours post CRRT treatment initiation

  2. Extracorporeal Circuit Ionized Calcium by Hour

    Post-filter blood iCa concentrations will only be measured in the Prismocitrate 18 arm. The extracorporeal circuit (post-filter).

    Measured: Up to 120 hours post CRRT treatment initiation

  3. Delivery of Prescribed CRRT Dose by Day

    Evaluates the efficacy of using Prismocitrate 18 in delivering the prescribed CRRT dose, with delivered dose based on (daily) average effluent rate divided by (daily) average weight and expressed as mL/kg/hour.

    Measured: Up to 120 hours post CRRT treatment initiation

  4. Number of Investigator Site Facilities That Passed Prismocitrate 18 Training Assessment

    Training conducted on administration of Prismocitrate 18 to demonstrate the understanding of the user groups on how to use the solution by passing an assessment at the end of training. The user groups who needed to be assessed prior to use of Prismocitrate 18 in the clinical trial setting were to be comprised of physicians, nurses, and other clinicians who were part of prescribing, initiating or modifying treatment during the 120 hour Treatment Period. The training assessment was housed on a restricted access study website. Study personnel who completed the training assessment have a completion date listed which indicates that the individual received a passing score of 80% or better on the training assessment.

    Measured: Prior to study use of Prismocitrate 18

  5. Change From Baseline in Serum Bicarbonate by Hour

    Measured: Baseline and up to 120 hours post CRRT treatment initiation

  6. Change From Baseline in pH by Hour

    Measured: Baseline and up to 120 hours post CRRT treatment initiation

  7. Change From Baseline in Base Excess by Hour

    Measured: Baseline and up to 120 hours post CRRT treatment initiation

  8. Change From Baseline in Blood Total Calcium Concentration by Hour

    Measured: Baseline and up to 120 hours post CRRT treatment initiation

  9. Change From Baseline in Serum Sodium by Hour

    Measured: Baseline and up to 120 hours post CRRT treatment initiation

  10. Change From Baseline in Serum Anion Gap by Hour

    Measured: Baseline and up to 120 hours post CRRT treatment initiation

  11. Change From Baseline in Serum Magnesium by Hour

    Measured: Baseline and up to 120 hours post CRRT treatment initiation

  12. Change From Baseline in Serum Phosphate by Hour

    Measured: Baseline and up to 120 hours post CRRT treatment initiation

  13. Change From Baseline in Serum Potassium by Hour

    Measured: Baseline and up to 120 hours post CRRT treatment initiation

  14. Change From Baseline in Serum Chloride by Hour

    Measured: Baseline and up to 120 hours post CRRT treatment initiation

  15. Number of Participants With Bleeding Events

    Measured: Up to 120 hours post CRRT treatment initiation

  16. Number of Participants by Number of Blood Transfusions

    Measured: Up to 120 hours post CRRT treatment initiation

  17. Number of Participants Reporting Any Baxter Device/Product Related Adverse Events (Serious and Non-Serious)

    Measured: Up to 30 days post study CRRT treatment completion

  18. Change From Baseline in Blood Pressure at Last Visit

    Measured: Baseline and up to 120 hours post CRRT treatment initiation

  19. Change From Baseline in Respiratory Rate at Last Visit

    Measured: Baseline and up to 120 hours post CRRT treatment initiation

  20. Change From Baseline in Temperature at Last Visit

    Measured: Baseline and up to 120 hours post CRRT treatment initiation

  21. Change From Baseline in Pulse at Last Visit

    Measured: Baseline and up to 120 hours post CRRT treatment initiation

  22. Change From Baseline in Total Calcium/iCa Ratio by Hour

    Measured: Baseline and up to 120 hours post CRRT treatment initiation

  23. Number of Bleeding Events by Location

    Measured: Up to 120 hours post CRRT treatment initiation

  24. Duration of Bleeding Events

    Measured: Up to 120 hours post CRRT treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2016 (estimated)
  2. Study start27 Sep 2016
  3. Primary completion12 May 2018
  4. Study completion12 May 2018

Why it stopped: Study halted due to low recruitment, unrelated to safety or efficacy reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02860130
Sponsor's protocol ID
1407-004
Status last verified
Jul 2025
First submitted
29 Jul 2016
Last updated
22 Jul 2025
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 33314078

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prismocitrate 18 and No Anticoagulation in people with Regional Citrate Anticoagulation (RCA) and Continuous Renal Replacement Therapy (CRRT), run by Vantive Health LLC at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Occurrence of Selected Prismaflex® System Alarms/Conditions (time frame: Up to 120 hours post CRRT treatment initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02860130, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.

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