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NCT01318811 · ClinicalTrials.gov registry record · Phase 4
A Comparison of Dilute Versus Concentrated Heparin for CRRT Anticoagulation
A Phase 4 study, sponsored by Vanderbilt University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT01318811: Clinical Trial Phase 4 study, sponsored by Vanderbilt University.
NCT01318811 is a Phase 4 study that was terminated before completion, run by Vanderbilt University. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01318811, a Phase 4 study, was terminated before completion, sponsored by Vanderbilt University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study Summary
Heparin is commonly used for anticoagulation of the extracorporeal circuit during continuous renal replacement therapy (CRRT) but the optimal mode of delivery has not yet been validated. Our study will compare dilute heparin to a standard concentration of heparin. The investigators hypothesize that heparin delivered in a dilute solution will augment coating of the filter fibers with anticoagulants, decreasing clotting events and increasing filter life. By improving delivery of heparin to the filter and circuit, where clotting events can disrupt dialysis, less heparin would be required for the extra-corporeal circuit and thus less heparin would be delivered back to the patient with blood return from the machine. By exposing the patient to less heparin it is hypothesized that fewer bleeding events would occur, making the dialysis treatment safer. If more of the filter's fibers remain patent and the filter is functional for a longer period of time, the CRRT would also be more effective.
Primary Outcome
The primary endpoint for this study will be the difference in filter life in hours between the group receiving dilute heparin and the group receiving standard concentrated heparin.
Interventions
- DRUG Dilute unfractionated heparin
- DRUG Standard concentration unfractionated heparin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2011-03 |
| Est. Completion | 2016-04-03 |
| Phase | Phase 4 |
Why NCT01318811 stopped before completion
NCT01318811 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Dilute unfractionated heparin is the first listed.
NCT01318811 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01318811 about?
NCT01318811 is a clinical study titled "A Comparison of Dilute Versus Concentrated Heparin for CRRT Anticoagulation". Heparin is commonly used for anticoagulation of the extracorporeal circuit during continuous renal replacement therapy (CRRT) but the optimal mode of delivery has not yet been validated. Our study will compare dilute heparin to a standard concentration of heparin. The investigators hypothesize that ...
What is the current status of trial NCT01318811?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2011-03. Estimated completion is 2016-04-03.
What interventions are being tested in trial NCT01318811?
The interventions under investigation include: Dilute unfractionated heparin (DRUG), Standard concentration unfractionated heparin (DRUG).
Who is sponsoring clinical trial NCT01318811?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01318811's enrollment target sits among peer trials
12 1913th of 2000 higher than 70 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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