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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Venous Thrombosis Deep (Limbs), Surgical Blood Loss

In brief

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.

Key facts

Study ID

NCT05081375

Run by

Valleywise Health

People needed

6

Starts

2019-12-16

Expected to finish

2023-11-02

Last updated by the study team

2024-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years
• Traumatic injury of long bones or pelvis requiring surgical intervention
• Admission to the ICU

You may not qualify if…

• Age < 18 years
• Intracranial hemorrhage
• Direct admit to OR without prior ICU admission
• Pregnancy
• Prisoner
• Chronic Kidney Disease requiring dialysis or a glomerular filtration rate (GFR) or creatinine clearance requiring a decrease in Enoxaparin dosage
• Presence of DVT prior to study drug dose

Where it is running

• Valleywise Health — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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