Evaluation of Chemical Venous Thromboembolism Prophylaxis in Trauma
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06025162 |
Recruitment Status :
Enrolling by invitation
First Posted : September 6, 2023
Last Update Posted : September 6, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Thromboembolism, Venous | Drug: enoxaparin |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Evaluation of Chemical Venous Thromboembolism Prophylaxis in Trauma |
Actual Study Start Date : | July 21, 2023 |
Estimated Primary Completion Date : | August 31, 2024 |
Estimated Study Completion Date : | August 31, 2024 |
Group/Cohort | Intervention/treatment |
---|---|
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
dose of enoxaparin at 48 hours post-VTE prophylaxis initiation
Other Name: Accessing for contraindication for chemical VTE prophylaxis |
- Episodes of clinically significant bleeding after VTE prophylaxis initiation [ Time Frame: "48 Hours" ]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.
- Time to clinically significant bleeding after VTE prophylaxis initiation [ Time Frame: "48 Hours" ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- ≥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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06025162
United States, Texas | |
Methodist Dallas Medical Center Pharmacy | |
Dallas, Texas, United States, 75203 |
Principal Investigator: | Tamara Reiter, PharmD | Methodist Health System |
Responsible Party: | Methodist Health System |
ClinicalTrials.gov Identifier: | NCT06025162 |
Other Study ID Numbers: |
028.PHA.2022.D |
First Posted: | September 6, 2023 Key Record Dates |
Last Update Posted: | September 6, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Thromboembolism Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Enoxaparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |