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NCT03516656 · ClinicalTrials.gov registry record · Early Phase 1
Evaluation of Anti-Xa Levels in Surgery Patients Receiving Weight-based Heparin
A Early Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT03516656 is a Early Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 20 participants.
The verdict
NCT03516656, a Early Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if weight-based heparin infusions at a rate of 10 units/kg/hour are sufficient to maintain a target anti-Xa of 0.1-0.35 IU/mL for VTE prophylaxis in patients undergoing microvascular surgery. Additionally, a pilot protocol has been developed to titrate these heparin infusions to ensure patients have sufficient VTE prophylaxis. All patients will be enrolled in the observational arm of the study and receive anti-Xa level monitoring. Patients with out-of-range anti-Xa levels will cross over to the interventional arm of the study and receive real time heparin infusion dose adjustments per the pilot protocol. The primary outcome measured will be the percentage of patients with anti-Xa levels in the target range of 0.1-0.35 IU/mL while on a heparin infusion at 10 units/kg/hour.
Interventions
- DRUG Real time heparin dose adjustment
- DRUG Standard heparin dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-03-23 |
| Est. Completion | 2021-08-24 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03516656
The ClinicalTrials.gov registry entry for NCT03516656 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Real time heparin dose adjustment is the first listed.
NCT03516656 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03516656 about?
NCT03516656 is a clinical study titled "Evaluation of Anti-Xa Levels in Surgery Patients Receiving Weight-based Heparin". The purpose of this study is to determine if weight-based heparin infusions at a rate of 10 units/kg/hour are sufficient to maintain a target anti-Xa of 0.1-0.35 IU/mL for VTE prophylaxis in patients undergoing microvascular surgery. Additionally, a pilot protocol has been developed to titrate these...
What is the current status of trial NCT03516656?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2018-03-23. Estimated completion is 2021-08-24.
What interventions are being tested in trial NCT03516656?
The interventions under investigation include: Real time heparin dose adjustment (DRUG), Standard heparin dose (DRUG).
Who is sponsoring clinical trial NCT03516656?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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