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Anticoagulant

Enoxaparin for Deep Vein Thrombosis (FiXET Trial)

Phase 3

Waitlist Available

Led By Mihir Bhatt, MD

Research Sponsored by Hamilton Health Sciences Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-24 months

Awards & highlights

FiXET Trial Summary

This trial is testing whether a weight-adjusted, fixed dose of enoxaparin is safe and feasible for treating thrombosis in neonates and children, without monitoring anti-Xa levels.

Eligible Conditions

Deep Vein Thrombosis

FiXET Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recruitment Detection, Audiologic

Safety of administering a weight adjusted fixed dose of enoxaparin to neonates and children with thrombosis

Secondary outcome measures

Thrombosis

Safety of anticoagulation

FiXET Trial Design

2Treatment groups

Experimental Treatment

Group I: Experimental ArmExperimental Treatment1 Intervention

Experimental Arm:patients will not have any dose titration regardless of anti-Xa level. Premature neonates will receive enoxaparin 2.0 mg/kg/dose rounded to nearest whole mg twice daily, while term neonates will receive enoxaparin 1.7 mg/kg/dose rounded to nearest whole mg twice daily. Children≥1 month corrected age will receive 1.5 mg/kg/dose twice daily (maybe rounded +/- 10% for convenience of dosing) while children≥2 month corrected age will receive 1.0 mg/kg/dose twice daily (maybe rounded +/- 10% for convenience of dosing).

Group II: Control ArmExperimental Treatment1 Intervention

Control Arm: patients who will have dose titration based on anti-Xa levels to maintain a therapeutic range of 0.5-1.0 u/mL (standard of care).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enoxaparin

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor

368 Previous Clinical Trials

300,973 Total Patients Enrolled

5 Trials studying Deep Vein Thrombosis

2,859 Patients Enrolled for Deep Vein Thrombosis

IWK Health CentreOTHER

125 Previous Clinical Trials

100,453 Total Patients Enrolled

Children's Hospital of PhiladelphiaOTHER

707 Previous Clinical Trials

8,581,271 Total Patients Enrolled

2 Trials studying Deep Vein Thrombosis

276 Patients Enrolled for Deep Vein Thrombosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any risks associated with the use of Enoxaparin?

"Enoxaparin's Phase 3 status on Power's scale indicates that it has some efficacy data and multiple rounds of safety data, making it a safe choice."

Answered by AI

What other research projects have included Enoxaparin in their experimental designs?

"Currently, there are 24 different clinical trials studying the effects of Enoxaparin. 8 of those trials are in Phase 3. Although the majority of theEnoxaparin trials are based in Milwaukee, Wisconsin, there are a total of 381 locations running these sorts of trials."

Answered by AI

Enoxaparin is most commonly used for what treatments?

"Enoxaparin can be used to ameliorate the symptoms of acute chest syndrome, unstable angina, and outpatients."

Answered by AI

At how many different sites is this trial taking place?

"To make the trial more accessible to patients, it is being run out of 4 sites. The locations are based in Halifax, Hamilton and Ottawa, as well as 4 other locations. If you enroll in the trial, try to choose the location nearest to you to reduce travel time and demands."

Answered by AI

Are new volunteers needed for this clinical trial?

"From what is indicated on clinicaltrials.gov, it appears that this trial is still recruiting patients. The earliest posting date for the trial was March 1st, 2016 with the latest update being October 14th, 2021."

Answered by AI

How many people have signed up for this clinical trial thus far?

"Yes. The clinical trial is recruiting patients, as stated on clinicaltrials.gov. This trial was originally posted on 2016-03-01 and was most recently edited on 2021-10-14. The trial is looking for 20 participants at 4 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pilot Feasibility and Safety of Administering Weight Adjusted Fixed LMWH Dose

2016. "Pilot Feasibility and Safety of Administering Weight Adjusted Fixed LMWH Dose". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02486666.