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

NCT05081375 | Terminated Phase 4 FDA Drug

• 1 other identifier: 2019-071
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

prophylaxis of DVT

Outcome Measures

Primary Outcomes (2)

• Evaluate Bleeding Complications Related to DVT chemoprophylaxis

  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.

  From the time of study drug administration to 24 hours post-operation

• Evaluate Other Complications (besides bleeding) Related to DVT chemoprophylaxis

  Evaluate the rate of other complications (besides bleeding) 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.

  From the time of study drug administration to 24 hours post-operation

Secondary Outcomes (3)

• Incidence of DVT and PE

  From the time of study drug administration to hospital discharge up to 3 months

• study duration

  From Institutional Review Board approval to date of last subject completion up to 2 years

• Assess feasibility of a larger trial with respect to study design

  Duration of the study up to 2 years

Study Arms (2)

Enoxaparin

ACTIVE COMPARATOR

Enoxaparin dose will not be held for surgical procedure.

Drug: Enoxaparin Injectable Product

Placebo dose given and Enoxaparin dose held

PLACEBO COMPARATOR

Enoxaparin dose will be held and replaced by placebo and not given prior to surgical procedure.

Drug: Sodium chloride

Interventions

Enoxaparin Injectable Product DRUG

Not holding prophylaxis dose prior to surgical procedure

Also known as: Lovenox

Enoxaparin

Sodium chloride DRUG

Holding prophylaxis dose of Enoxaparin replacing with placebo

Also known as: Placebo

Placebo dose given and Enoxaparin dose held

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Valleywise Health: lead

Study Sites (1)

Valleywise Health

Phoenix, Arizona, 85008, United States

Location

MeSH Terms

Conditions

Venous Thrombosis; Blood Loss, Surgical

Interventions

Enoxaparin; Sodium Chloride

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Thomas Wertin, MD, FACS

  Valleywise Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Blinding will be done by research pharmacist. Nurse Manager will also be un-blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Blinded, Controlled, Randomized, Safety Study

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: October 18, 2021
• Study Start: December 16, 2019
• Primary Completion: November 2, 2023
• Study Completion: November 2, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)