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Anticoagulant
Pre-operative Enoxaparin for Blood Clots
Phase 4
Waitlist Available
Led By Thomas Wertin, MD, FACS
Research Sponsored by Valleywise Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of the study up to 2 years
Awards & highlights
Summary
This trial is testing whether it's better to give a blood-thinning drug before or after surgery to people with orthopedic injuries.
Who is the study for?
This trial is for adults over 18 who are in the ICU due to traumatic injuries needing surgery on long bones or pelvis. It's not for those under 18, pregnant, prisoners, directly admitted to OR without ICU stay, with brain hemorrhage, severe kidney issues requiring dialysis or already have a blood clot.
What is being tested?
The study tests if giving Enoxaparin (a blood thinner) before surgery is safe and effective compared to after surgery in preventing blood clots. Participants will be randomly assigned to receive either Enoxaparin or a placebo before their operation.
What are the potential side effects?
Possible side effects include increased risk of bleeding during and after surgery. Since it's aimed at preventing deep vein clots, there may also be risks associated with thinning the blood too much.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of the study up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of the study up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hemorrhage
Evaluate Other Complications (besides bleeding) Related to DVT chemoprophylaxis
Secondary outcome measures
Assess feasibility of a larger trial with respect to study design
Incidence of DVT and PE
study duration
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: EnoxaparinActive Control1 Intervention
Enoxaparin dose will not be held for surgical procedure.
Group II: Placebo dose given and Enoxaparin dose heldPlacebo Group1 Intervention
Enoxaparin dose will be held and replaced by placebo and not given prior to surgical procedure.
Find a Location
Who is running the clinical trial?
Valleywise HealthLead Sponsor
14 Previous Clinical Trials
3,459 Total Patients Enrolled
Thomas Wertin, MD, FACSPrincipal InvestigatorValleywise Health
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have bleeding inside your brain.You have chronic kidney disease that needs dialysis, or your kidney function is not normal, which means you need a lower dose of Enoxaparin.You have had a blood clot in your legs before starting the study drug.You are older than 18 years.You recently had a serious injury to your long bones or pelvis that needed surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Enoxaparin
- Group 2: Placebo dose given and Enoxaparin dose held
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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