Thromboembolic Complications Clinical Trial
Official title:
Thrombelastography Based Dosing of Enoxaparin for Thromboprophylaxis: a Prospective Randomized Trial
The risk of developing a blood clot occurs in up to 60% of all critical care patients. Many
times enoxaparin (or Lovenox®) is given to patients who are at a higher risk of developing
clots in their legs or lungs. Recent data suggest that a standard dose of Lovenox may not
fully prevent the development of these clots especially in critically ill or obese patients.
Routine enoxaparin dosing can also result in bleeding complications. Thrombelastography
(TEG®) can be used to measure how blood clots. The purposes of this study are:
- to learn if the TEG® can better guide physicians in prescribing an effective dose of
Lovenox compared to standard doses recommended by the drug company in preventing blood
clots from developing in the legs and lungs, and
- to compare the development of blood clots in patients receiving the standard dose of
enoxaparin compared to patients receiving a TEG® guided dose of enoxaparin.
- to determine if TEG guided dosing results in decreased bleeding complications compared
to standard dosing.
Hypothesis:
Enoxaparin dosed to maintain a TEG® ΔR greater than 1.0 minute will decrease the incidence of
DVT compared to standard dosing.
Initiation of enoxaparin thromboprophylaxis will be done by the treatment team. Once
enrolled, the subject will be randomized to continue receiving standard dose enoxaparin (30
mg twice daily) or variable TEG® guided enoxaparin dosing. The treatment team and the subject
will be blinded regarding the arm in which the patient is enrolled. Patient characteristics:
age, gender, body mass index (BMI), comorbidities, Acute Physiology and Chronic Health
Evaluation II score (APACHE II), injuries, and operations will be collected. As part of
standard protocol in the ICU, all patients will undergo weekly ultrasound duplex examination
of the lower extremities for presence of deep venous thrombosis.
A baseline TEG® will be completed on each patient when they are enrolled in the study. The
blood will be drawn between four and six hours after the morning dose is administered,
corresponding to maximum tissue levels of enoxaparin. TEG® assays will be run in duplicate
for each patient, with and without heparinase, which negates the effects of enoxaparin in the
assay.
Those patients randomized to the control arm of the study will have TEG® performed at
baseline and daily for one week, then twice weekly. The twice weekly TEG® assays will be done
until the patient is discharged from inpatient care or enoxaparin is discontinued by the
treatment team. No adjustments will be made to their enoxaparin dosing.
Patients in the TEG® guided enoxaparin dosing arm will start treatment as ordered by the
primary treatment team. After the second TEG®, the dose of enoxaparin will be adjusted in 10
mg increments per dose in order to reach a target ΔR between 1.0 and 1.4 minutes. If the
initial ΔR is greater than 1.4 minutes, the dose of enoxaparin will be decreased by 10 mg
increments until the target ΔR is achieved. Patients will have TEGs® performed daily and
adjustment of dosing until the target ΔR is reached. Once the target ΔR is achieved, TEG®
will be done twice weekly until the patient is discharged from inpatient care or enoxaparin
is discontinued by the treatment team. All patients will be assessed daily by study personnel
for bleeding complications. If bleeding complications occur, subjects will be withdrawn from
the study. If interim analysis identifies a significant difference in bleeding complications
between groups the study will be terminated.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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