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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06025162
Other study ID # 028.PHA.2022.D
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date July 21, 2023
Est. completion date August 31, 2024

Study information

Verified date September 2023
Source Methodist Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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Study Design


Intervention

Drug:
enoxaparin
dose of enoxaparin at 48 hours post-VTE prophylaxis initiation

Locations

Country Name City State
United States Methodist Dallas Medical Center Pharmacy Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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"
Primary 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"
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