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NCT02366845 · ClinicalTrials.gov registry record · Phase 4
Prospective Validation of a Plasma Transfusion Dosing Algorithm in Patients With Chronic Liver Disease
A Phase 4 study of Liver Disease, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT02366845: Completed Phase 4 study of Liver Disease, sponsored by University of Colorado, Denver.
NCT02366845 is a Phase 4 study of Liver Disease that has completed, run by University of Colorado, Denver. The registered enrollment target is 50 participants, below the 792-participant average among 14 other Liver Disease trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02366845, a Phase 4 study of Liver Disease, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This study plans to learn more about transfusion of a human blood component called plasma in patients who have liver problems. Patients are asked to be in this study because they have liver disease and therefore may require the transfusion of plasma. The dose of plasma required to reach certain blood clotting laboratory targets is usually determined by clinicians. Due to the complexity of the patient's blood clotting disorder, determining the appropriate dose of plasma is very difficult. The investigators have developed a dosing table based on information from other patients with liver disease and the investigators are testing it to see if it is a more accurate dosing tool then clinician chosen dosing of plasma in patients with liver disease who need one or more plasma transfusions
Primary Outcome
Ability of dosing algorithm to accurately predict necessary plasma dose (ml/kg), required to reach commonly targeted International Normalized Ratio (INR) values, compared to clinician chosen plasma transfusion dose, as determined by dose-response curve. The primary outcome was achievement of the target INR within ±0.1 after the first round of FFP transfusion. This primary outcome was selected because underdosing can result in prolonged bleeding, delayed procedure times, and more rounds of FFP t
Conditions Studied
Interventions
- BIOLOGICAL Fresh Frozen Plasma
- DIAGNOSTIC_TEST Pre-Transfusion International Normalized Ratio (INR)
- DIAGNOSTIC_TEST Post-Transfusion International Normalized Ratio (INR)
Study Locations (1)
Colorado
- University of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-06-27 |
| Est. Completion | 2019-03-27 |
| Phase | Phase 4 |
What the finished NCT02366845 record still lists
NCT02366845 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 792-participant average among 14 other Liver Disease trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Liver Disease appearing as the primary indexed condition, and to 3 interventions - of which Fresh Frozen Plasma is the first listed.
NCT02366845 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT02366845 about?
NCT02366845 is a clinical study titled "Prospective Validation of a Plasma Transfusion Dosing Algorithm in Patients With Chronic Liver Disease". This study plans to learn more about transfusion of a human blood component called plasma in patients who have liver problems. Patients are asked to be in this study because they have liver disease and therefore may require the transfusion of plasma. The dose of plasma required to reach certain blo...
What is the current status of trial NCT02366845?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2012-06-27. Estimated completion is 2019-03-27.
What conditions does trial NCT02366845 study?
This clinical trial studies the following conditions: Liver Disease.
What interventions are being tested in trial NCT02366845?
The interventions under investigation include: Fresh Frozen Plasma (BIOLOGICAL), Pre-Transfusion International Normalized Ratio (INR) (DIAGNOSTIC_TEST), Post-Transfusion International Normalized Ratio (INR) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT02366845?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02366845 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Liver Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02366845's enrollment target sits among peer trials
50 8th of 14 higher than 7 of 14 other Liver Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Liver Disease 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.
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