NCT00351663

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2006

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

7.2 years

First QC Date

July 12, 2006

Last Update Submit

April 19, 2016

Conditions

Venous ThrombosisCritical Illness

Keywords

Venous ThrombosisCritical IllnessBlood CoagulationFactor Xa

Outcome Measures

Primary Outcomes (1)

  • To determine the effect of the dosing protocols of enoxaparin for critically ill patients on aFXa activity

    5 days

Secondary Outcomes (1)

  • bleeding/thrombotic complications

    7 days

Study Arms (3)

IV by weight

ACTIVE COMPARATOR

intravenous dose of 0.5 mg/kg enoxaparin once daily

Drug: Enoxaparine

SC fixed dose

ACTIVE COMPARATOR

subcutaneous fixed dose of 40 mg enoxaparin once daily

Drug: Enoxaparine

SC by weight

ACTIVE COMPARATOR

subcutaneous dose of 0.5 mg/kg enoxaparin once daily

Drug: Enoxaparine

Interventions

EnoxaparineDRUG

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

IV by weightSC by weightSC fixed dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Related Publications (1)

  • Helviz Y, Dzigivker I, Raveh-Brawer D, Hersch M, Zevin S, Einav S. Anti-Factor Xa Activity of Prophylactic Enoxaparin Regimens in Critically Ill Patients. Isr Med Assoc J. 2016 Feb;18(2):108-13.

    PMID: 26979004RESULT

MeSH Terms

Conditions

Venous ThrombosisCritical IllnessThrombosis

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Sharon Einav-Bromiker, MD

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 12, 2006

First Posted

July 13, 2006

Study Start

February 1, 2007

Primary Completion

April 1, 2014

Study Completion

September 1, 2015

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

IL(1)