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NCT02970032 · ClinicalTrials.gov registry record · Early Phase 1
Evaluation of Anti-Xa Levels in Surgery Patients Receiving Fixed Dose Heparin
A Early Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT02970032 is a Early Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 20 participants.
The verdict
NCT02970032, 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 fixed dose heparin infusions at a rate of 500 units/hour are sufficient to maintain a target anti-Xa of 0.1-0.35 IU/mL for venous thromboembolism (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 500 units/hour.
Interventions
- DRUG Real time heparin dose adjustment
- DRUG Standard heparin dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-11-10 |
| Est. Completion | 2017-12-08 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02970032
The ClinicalTrials.gov registry entry for NCT02970032 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.
NCT02970032 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02970032 about?
NCT02970032 is a clinical study titled "Evaluation of Anti-Xa Levels in Surgery Patients Receiving Fixed Dose Heparin". The purpose of this study is to determine if fixed dose heparin infusions at a rate of 500 units/hour are sufficient to maintain a target anti-Xa of 0.1-0.35 IU/mL for venous thromboembolism (VTE) prophylaxis in patients undergoing microvascular surgery. Additionally, a pilot protocol has been devel...
What is the current status of trial NCT02970032?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2016-11-10. Estimated completion is 2017-12-08.
What interventions are being tested in trial NCT02970032?
The interventions under investigation include: Real time heparin dose adjustment (DRUG), Standard heparin dose (DRUG).
Who is sponsoring clinical trial NCT02970032?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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