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NCT05081375 · ClinicalTrials.gov registry record · Phase 4
Pre-operative Enoxaparin in the Surgical Management of Multi-trauma Patients Undergoing Orthopedic Surgical Procedures
A Phase 4 study, sponsored by Valleywise Health.
- Terminated
- Registry status
- Phase 4
- Development phase
- 6
- Enrollment target
NCT05081375: Clinical Trial Phase 4 study, sponsored by Valleywise Health.
NCT05081375 is a Phase 4 study that was terminated before completion, run by Valleywise Health. The registered enrollment target is 6 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05081375, a Phase 4 study, was terminated before completion, sponsored by Valleywise Health.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 6 participants
- Enrollment target
Study Summary
All trauma patients receive Lovenox or other prophylactic medication to prevent deep vein clots from forming. For the trauma patients with orthopedic injuries requiring surgery there is controversy over safety and efficacy when prophylaxis is started preoperatively vs postoperatively. This study is to evaluate both approaches for safety in terms of bleeding events during and 24 hours after surgery as well as preventing deep vein clot formation. This will be a randomized double blinded study using Lovenox or placebo as the medications given preoperatively. Postoperative Lovenox will be given to both groups per routine regime.
Primary Outcome
Evaluate the rate of bleeding complications related to DVT chemoprophylaxis after administering DVT chemoprophylaxis vs holding doses within 12 hours of surgery in patients with long bones and/or pelvic fractures requiring surgical intervention.
Interventions
- DRUG Enoxaparin Injectable Product
- DRUG Sodium chloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2019-12-16 |
| Est. Completion | 2023-11-02 |
| Phase | Phase 4 |
Why NCT05081375 stopped before completion
NCT05081375 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Enoxaparin Injectable Product is the first listed.
NCT05081375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05081375 about?
NCT05081375 is a clinical study titled "Pre-operative Enoxaparin in the Surgical Management of Multi-trauma Patients Undergoing Orthopedic Surgical Procedures". All trauma patients receive Lovenox or other prophylactic medication to prevent deep vein clots from forming. For the trauma patients with orthopedic injuries requiring surgery there is controversy over safety and efficacy when prophylaxis is started preoperatively vs postoperatively. This study is ...
What is the current status of trial NCT05081375?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 6 participants. The study started on 2019-12-16. Estimated completion is 2023-11-02.
What interventions are being tested in trial NCT05081375?
The interventions under investigation include: Enoxaparin Injectable Product (DRUG), Sodium chloride (DRUG).
Who is sponsoring clinical trial NCT05081375?
This trial is sponsored by Valleywise Health, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05081375's enrollment target sits among peer trials
6 1983rd of 2000 higher than 12 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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