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Anti-factor Xa Based Venous Thromboembolism Prophylaxis

Primary Purpose

Dose Adjustment of Enoxaparin in ICU Patients

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Dose adjustment of Enoxaparin in patients with sub-therapuetic (prophylactic) levels of factor 10a
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dose Adjustment of Enoxaparin in ICU Patients

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Inclusion criteria were age over 18 years and a predicted ICU stay of more than 72 h.

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Exclusion Criteria: Exclusion criteria were any contraindication for heparin-based thromboembolic prophylaxis, patients with an indication for therapeutic anticoagulation , administration of unfractioned-heparin or low-molecular-weight-heparin prior to study entry, active hemorrhage, or creatinine clearance < 30 mL/min.

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Sites / Locations

  • Meir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Patients with target factor 10a levels

Patients with sub-therapuetic factor 10a levels

Arm Description

Patients with target factor 10a levels continued to recieve the standard Enoxaparin dose of 40 mg SC daily.

In patients with sub-therapuetic factor 10a levels we increased the Enoxaparin dose to 60 mg SC daily.

Outcomes

Primary Outcome Measures

Peak aFXa levels following 2 consecutive doses of sc 40 mg enoxaparin
We measured peak aFXa levels following 2 consecutive doses of sc 40 mg enoxaparin among ICU patients who recieved enoxaparin for VTE prophylaxis..

Secondary Outcome Measures

Full Information

First Posted
January 9, 2022
Last Updated
January 23, 2022
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05221879
Brief Title
Anti-factor Xa Based Venous Thromboembolism Prophylaxis
Official Title
Anti-factor Xa Based Venous Thromboembolism Prophylaxis: Dose Adjustment in ICU Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 23, 2019 (Actual)
Primary Completion Date
February 15, 2021 (Actual)
Study Completion Date
February 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Introduction: Venous thromboembolism (VTE) in the intensive care unit (ICU) is associated with significant morbidity and mortality therefore prevention is imperative to reduce its burden. VTE prophylaxis in ICU patients is primarily pharmacological using low molecular weight heparin. This study aims to determine the proportion of ICU patients receiving VTE prophylaxis that achieves appropriate anti-factor Xa activity (aFXa) prophylactic levels and to characterize this patient population Methods: Seventy-five patients admitted to the General ICU were included. Peak and trough aFXa levels were measured at 4 and 23 hours respectively after receiving the second consecutive daily enoxaparin 40 mg sc injection. Patients in whom peak aFXa levels were found to be sub-prophylactic, peak and trough levels were repeated as above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dose Adjustment of Enoxaparin in ICU Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with target factor 10a levels
Arm Type
No Intervention
Arm Description
Patients with target factor 10a levels continued to recieve the standard Enoxaparin dose of 40 mg SC daily.
Arm Title
Patients with sub-therapuetic factor 10a levels
Arm Type
Other
Arm Description
In patients with sub-therapuetic factor 10a levels we increased the Enoxaparin dose to 60 mg SC daily.
Intervention Type
Other
Intervention Name(s)
Dose adjustment of Enoxaparin in patients with sub-therapuetic (prophylactic) levels of factor 10a
Intervention Description
We screened ICU patients who recieved DVT prophylaxis with fixed dose of Enoxaparin (40 mg SC daily) for peak blood levels of factor 10A. For patients who did not achieve therapuetic 10a levels (0.2-0.4) we increased the Enoxaparin dose to 60 mg SC daily.
Primary Outcome Measure Information:
Title
Peak aFXa levels following 2 consecutive doses of sc 40 mg enoxaparin
Description
We measured peak aFXa levels following 2 consecutive doses of sc 40 mg enoxaparin among ICU patients who recieved enoxaparin for VTE prophylaxis..
Time Frame
Up to 72 hours from ICU admission.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria were age over 18 years and a predicted ICU stay of more than 72 h. - Exclusion Criteria: Exclusion criteria were any contraindication for heparin-based thromboembolic prophylaxis, patients with an indication for therapeutic anticoagulation , administration of unfractioned-heparin or low-molecular-weight-heparin prior to study entry, active hemorrhage, or creatinine clearance < 30 mL/min. -
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Anti-factor Xa Based Venous Thromboembolism Prophylaxis

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