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Pre-operative Enoxaparin in the Surgical Management of Multi-trauma Patients Undergoing Orthopedic Surgical Procedures

NCT05081375 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-04-24

No results posted yet for this 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.

Conditions

  • Venous Thrombosis Deep (Limbs)
  • Surgical Blood Loss

Interventions

DRUG

Enoxaparin Injectable Product

Not holding prophylaxis dose prior to surgical procedure

DRUG

Sodium chloride

Holding prophylaxis dose of Enoxaparin replacing with placebo

Sponsors & Collaborators

  • Valleywise Health

    lead OTHER

Principal Investigators

  • Thomas Wertin, MD, FACS · Valleywise Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2023-11-02
Completion
2023-11-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05081375 on ClinicalTrials.gov