Status:
COMPLETED
The Effect of Vasopressors on the Anti Xa Response to Enoxaparin in Critically Ill Patients
Lead Sponsor:
Shaare Zedek Medical Center
Conditions:
Venous Thrombosis
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 betwee...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
- \-
Exclusion
- Patients requiring full anticoagulation
- Administration of unfractionated heparin in the 8hrs preceding study entry
- Existing contraindication to prophylactic dose of enoxaparin.
- Platelets \< 75,000
- Significant renal failure (creatinine clearance \<30 ml/min/m2) \[39\]
- BMI \> 30
- INR \> 1.7
- Any conditions precluding treatment in the opinion of the primary physician
- Patient /surrogate refusal
- \-
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00351663
Start Date
February 1 2007
End Date
September 1 2015
Last Update
April 20 2016
Active Locations (1)
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1
Shaare Zedek Medical Center
Jerusalem, Israel, 91031