Evaluation of Chemical Venous Thromboembolism Prophylaxis in Trauma

NCT06025162 | Unknown

• 1 other identifier: 028.PHA.2022.D
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Venous thromboembolism (VTE) causes up to 100,000 deaths annually. Between 10%-30% of patients die within one month of VTE diagnosis, while survivors remain at increased risk for VTE recurrence or other complications like post-thrombotic syndrome or chronic pulmonary hypertension in the following decade. Trauma patients have many risk factors that predispose them to a VTE. During the first 48 hours after blunt trauma, patients are prothrombotic due to the release of procoagulant factors, have excessive thrombin generation due to extensive tissue and vascular injury, and have reduced circulation of endogenous anticoagulants like protein C.

Conditions

Thromboembolism, Venous

Outcome Measures

Primary Outcomes (2)

• Episodes of clinically significant bleeding after VTE prophylaxis initiation

  High-risk factors for VTE included a history of VTE, repair or ligation of major venous injury, an abbreviated injury scale (AIS) \>2 for the head, a Glasgow coma Scale (GCS) score \<8 for \>4 hours after trauma, and age ≥60 years. Very high-risk factors for VTE consist of complex lower extremity fractures, pelvic fractures, spinal cord injury with associated para- or quadriplegia, and age ≥75 years.

  "48 Hours"

• Time to clinically significant bleeding after VTE prophylaxis initiation

  During the first 48 hours after blunt trauma, patients are prothrombotic due to the release of procoagulant factors, have excessive thrombin generation due to extensive tissue and vascular injury, and have reduced circulation of endogenous anticoagulants like protein C.5,6 Trauma patients are immobile for prolonged periods of time due to frequent surgical intervention and extended sedation.

  "48 Hours"

Study Arms (1)

LMWH dosing strategies

MDMC's trauma VTE prophylaxis guideline will be used to classify patients into two treatment arms ("weight-based" or "standard dose") based on their dose of enoxaparin at 48 hours post-VTE prophylaxis initiation

Drug: enoxaparin

Interventions

enoxaparin DRUG

dose of enoxaparin at 48 hours post-VTE prophylaxis initiation

Also known as: Accessing for contraindication for chemical VTE prophylaxis

LMWH dosing strategies

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective observational cohort study involving patients admitted to the trauma service at Methodist Dallas Medical Center between October 1, 2021 and March 31, 2022.

You may qualify if:

• ≥18 years of age
• Admitted to the trauma service between October 1,2021 and March 31, 2022
• Weight ≥50 kg
• Received chemical VTE prophylaxis with LMWH for at least 48 hours
• At "high risk" or "very high risk" of VTE8

You may not qualify if:

• Death, discharge, or hospice within 48 hours of admission
• Documented heparin allergy (heparin-induced thrombocytopenia)
• Indication for therapeutic anticoagulation, either prior to admission or during hospitalization
• Prisoners
• \<18 years of age
• Pregnancy

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center Pharmacy

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Enoxaparin; Contraindications

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Therapeutics

Study Officials

• Tamara Reiter, PharmD

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: September 6, 2023
• Study Start: July 21, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)