Aspirin and Enoxaparin for VTE in Trauma
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Cardiology, Hospital |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/9/2019 |
| Start Date: | February 2016 |
| End Date: | November 2018 |
The Role Of Combined Therapy With Aspirin and Enoxaparin In Prevention Of Venous Thromboembolism In Trauma Patients: A Randomized-Controlled Trial
The purpose of this study is to determine if the addition of antiplatelet therapy (i.e.
aspirin) to low-molecular-weight-heparin (i.e. enoxaparin) will decrease the incidence of
venous thromboembolism (VTE) in high-risk critically injured patients. The investigators
further aim to determine the safety and efficacy of dual thromboprophylaxis with aspirin and
enoxaparin for decreasing the incidence of VTE after trauma.
aspirin) to low-molecular-weight-heparin (i.e. enoxaparin) will decrease the incidence of
venous thromboembolism (VTE) in high-risk critically injured patients. The investigators
further aim to determine the safety and efficacy of dual thromboprophylaxis with aspirin and
enoxaparin for decreasing the incidence of VTE after trauma.
This is a prospective, randomized, controlled, open-label clinical trial evaluating the
effect of dual thromboprophylaxis with enoxaparin and aspirin versus enoxaparin alone on the
incidence of VTE in trauma patients. Once a trauma patient is admitted to the Intensive Care
Unit (ICU), study personnel will screen for entry criteria and, if eligible, will obtain
informed consent from the patient or healthcare proxy. After informed consent, subjects will
be randomized into one of 2 groups to receive either standard of care with enoxaparin alone
(control group) or dual thromboprophylaxis with enoxaparin plus aspirin (intervention group).
Alternative thromboprophylaxis will be permitted prior to consent or randomization or at
anytime at the discretion of the attending physician for any reason. Standard drug dosages
will be used (enoxaparin 30 mg subcutaneous twice daily; aspirin 81 mg oral daily).
All consented subjects will be followed from admission until discharge from the hospital.
Data collection will include demographic information, injury pattern, mechanism of injury,
need for surgical intervention, admission and daily laboratory values (e.g. basic metabolic
profile, complete blood count, coagulation studies, ROTEM), weekly venous duplex
ultrasonography (VDU), admission and subsequent radiologic examinations, medication
administration records (including missed doses of thromboprophylaxis), and outcomes measures
(complications, VTE, mortality). Blood samples for complete blood count and coagulation
studies will be ordered as medically necessary per the primary team; ROTEM samples will be
taken pre-prophylaxis and post-prophylaxis and will be run in the Trauma Research Office. The
amount drawn will not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and
collection will not occur more frequently than 2 times per week.
All clinical care will be at the discretion of the attending physician. Should the attending
physician choose to change thromboprophylaxis medication, this will be permitted for the
study and included in the data collection. Discontinuation of thromboprophylaxis generally
occurs in a standardized fashion once the patient is fully ambulatory; however, should the
attending physician stray from this regimen, it is permitted for the study and will be part
of the data collection.
For each patient admitted to the ICU and eligible for study participation, routine measures
already obtained by clinical staff will be collected/calculated.
effect of dual thromboprophylaxis with enoxaparin and aspirin versus enoxaparin alone on the
incidence of VTE in trauma patients. Once a trauma patient is admitted to the Intensive Care
Unit (ICU), study personnel will screen for entry criteria and, if eligible, will obtain
informed consent from the patient or healthcare proxy. After informed consent, subjects will
be randomized into one of 2 groups to receive either standard of care with enoxaparin alone
(control group) or dual thromboprophylaxis with enoxaparin plus aspirin (intervention group).
Alternative thromboprophylaxis will be permitted prior to consent or randomization or at
anytime at the discretion of the attending physician for any reason. Standard drug dosages
will be used (enoxaparin 30 mg subcutaneous twice daily; aspirin 81 mg oral daily).
All consented subjects will be followed from admission until discharge from the hospital.
Data collection will include demographic information, injury pattern, mechanism of injury,
need for surgical intervention, admission and daily laboratory values (e.g. basic metabolic
profile, complete blood count, coagulation studies, ROTEM), weekly venous duplex
ultrasonography (VDU), admission and subsequent radiologic examinations, medication
administration records (including missed doses of thromboprophylaxis), and outcomes measures
(complications, VTE, mortality). Blood samples for complete blood count and coagulation
studies will be ordered as medically necessary per the primary team; ROTEM samples will be
taken pre-prophylaxis and post-prophylaxis and will be run in the Trauma Research Office. The
amount drawn will not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and
collection will not occur more frequently than 2 times per week.
All clinical care will be at the discretion of the attending physician. Should the attending
physician choose to change thromboprophylaxis medication, this will be permitted for the
study and included in the data collection. Discontinuation of thromboprophylaxis generally
occurs in a standardized fashion once the patient is fully ambulatory; however, should the
attending physician stray from this regimen, it is permitted for the study and will be part
of the data collection.
For each patient admitted to the ICU and eligible for study participation, routine measures
already obtained by clinical staff will be collected/calculated.
Inclusion Criteria:
- Age 18 years or older
- Blunt or penetrating trauma
- Requires VTE thromboprophylaxis
- High-risk for VTE
Exclusion Criteria:
- Presence of VTE upon admission
- Pregnant or nursing
- Inability to give informed consent by patient or healthcare proxy
- Contraindication to enoxaparin
- Contraindication to aspirin
- Epidural or subdural hematoma
- Presence, or removal within the last 12 hours, of an epidural or spinal catheter, or
recent (within the last 12 hours) epidural or spinal anesthesia/procedures
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