A Phase 4 interventional study of Enoxaparine in Venous Thrombosis and Critical Illness, sponsored by Shaare Zedek Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-20.
Sponsored by Shaare Zedek Medical Center · Phase 4, Interventional, and Prevention
The purpose of this study is to evaluate the efficacy of 3 different dosing regimens of enoxaparin in achieving adequate antithrombotic aFXa levels in critically ill patients.
The relationship between appearance of DVT and antithrombotic aFXa levels will also be assessed and risk factors associated with inadequate aFXa levels under standard enoxaparin dosages will be searched for.
Critically ill patients are at increased risk of venous thrombosis and embolism from DVT. Low molecular weigh heparins such as enoxaparin (clexane) have more favorable pharmacokinetic/ pharmacodynamic profiles, equivalent or improved efficacy (e.g. in post trauma and orthopedic surgery patients) and fewer bleeding complications than low-dose unfractionated heparin. These medications are currently recommended for DVT prophylaxis in critically ill patients and are usually administered subcutaneously (SQ). The antithrombotic activity of LMWHs correlates with peak aFXa levels. However, the the appropriate dose and dosing interval of enoxaparin for DVT prophylaxis in critically ill surgical patients has not been established and in particular remains unknown for those patients with severe peripheral edema ans/or decreased peripheral circulation due to therapy with vasopressors. Several studies have recently demonstrated questionable efficacy of standard daily enoxaparin dosing for critically ill patients as DVT prophylaxis.
The current study will be a prospective, randomized, cohort study, conducted at the Shaare Zedek Medical Center over a period of 1 year (100 patients). All critically ill patients aged ≥18 years with a predicted requirement of mechanical ventilation for >3 days will be included. Data collection will be performed anonymously and will include patient demographics and admission details, duplex monitoring for DVT and daily recording of APACHE II scores, renal function, coagulation profile and overall dose of vasopressors.
Patients will be randomized to receive enoxaparin in accordance three DVT prophylaxis protocols- IV by weight, SQ by weight or SQ 40mg x1/day (standard). Blood samples for the evaluation of aFXa will be drawn twice daily for peak and trough activity over a period of 5 days. No further changes will be made in the standard therapy. Patient outcomes and occurrence of adverse events will be recorded. The principle outcome variable will be achievement of target peak and trough levels of aFXa during the 5 day study period.
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's enrollment of 39 is below the median of 106 across 849 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →Shaare Zedek Medical Center is the lead sponsor of 191 studies on the registry; 17 are open to participants now.
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All critically ill patients, aged ≥18 years, with a predicted requirement for mechanical ventilation of more than 3 days and for whom venous thromboembolic prophylaxis is indicated.
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Exclusion Criteria:
Patient /surrogate refusal
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intravenous dose of 0.5 mg/kg enoxaparin once daily
Drug: Enoxaparine
subcutaneous fixed dose of 40 mg enoxaparin once daily
Drug: Enoxaparine
subcutaneous dose of 0.5 mg/kg enoxaparin once daily
Drug: Enoxaparine
Patients considered eligible will be divided into 2 groups- those receiving vasopressor support and those not receiving vasopressor support at the time of inclusion. The patients in each group will be randomized to receive enoxaparin in accordance with one of the following DVT prophylaxis protocols: 1. Intravenous Enoxaparine according to their weight (0.5mg/kg x 1/day) 2. Subcutaneous Enoxaparine according to their weight (0.5mg/kg x 1/day) 3. Subcutaneous Enoxaparine 40mg x1/day
To determine the effect of the dosing protocols of enoxaparin for critically ill patients on aFXa activity
Time frame: 5 days
bleeding/thrombotic complications
Time frame: 7 days
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Shaare Zedek Medical Center