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Enoxaparin for Regional Anesthesia Morbidity

Phase 4
Waitlist Available
Led By Daryl S Henshaw, MD
Research Sponsored by Wake Forest University Health Sciences
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 anti-xa levels were measured at the time of presentation for surgery. gender was collected at the time of enrollment.
Awards & highlights

Study Summary

This trial is testing how long it takes for a blood-thinning drug to leave the system.

Eligible Conditions
  • Regional Anesthesia Morbidity
  • Anticoagulant and Bleeding Disorders
  • Surgery

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~anti-xa levels were measured at the time of presentation for surgery. age was collected at the time of enrollment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and anti-xa levels were measured at the time of presentation for surgery. age was collected at the time of enrollment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Residual Anti-Xa Activity Levels Following Last Treatment Dose of Enoxaparin
Time Point at Which Anti-Xa Activity is Lower Than 0.2 International Unit Per Milliliter (IU/mL) Using Modeling
Secondary outcome measures
Relationship Between Anti-Xa Levels and Patient Age
Relationship Between Anti-Xa Levels and Patients Gender (Sex)
Other outcome measures
Relationship Between Anti-Xa Levels and Patient Renal Function

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 36 Hours GroupExperimental Treatment1 Intervention
Group 2 will be instructed to administer their last dose of enoxaparin at 19:00 in the evening two days prior to their scheduled surgery date. Patients presenting for surgery at 07:00 two days later will be 36-hours removed from their last dose. Patients presenting for surgery later in the day would be slightly farther removed from their last dose, but again this mimics normal clinical practice in which the timing of the last dose of self-administered enoxaparin is not routinely adjusted based on the scheduled surgical start time.
Group II: 24 Hours groupActive Control1 Intervention
Group one will be instructed to administer their last dose of enoxaparin at 07:00 in the morning on the day prior to their scheduled surgery date. This will mean that patients who have their surgery scheduled for 07:00 the following day will be 24-hours removed from their last dose. Patients presenting for surgery later in the day would be slightly farther removed from their last dose, however this is currently considered normal clinical practice.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enoxaparin
2017
Completed Phase 4
~32400

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,145 Total Patients Enrolled
Daryl S Henshaw, MDPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
350 Total Patients Enrolled

Frequently Asked Questions

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

What potential hazards might Enoxaparin present to those who are being treated with it?

"There is ample clinical evidence confirming Enoxaparin's safety, resulting in a rating of 3."

Answered by AI

What is the current enrollment size of this medical experiment?

"Affirmative, the information hosted on clinicaltrials.gov reveals that this investigation is presently recruiting volunteers. The trial was initially published on October 24th 2017 and most recently updated December 16th 2021. 150 participants need to be enlisted over 1 medical centre."

Answered by AI

Is it permissible for individuals below the age of twenty to enroll in this investigation?

"This clinical trial welcomes those aged 18 and over, but no older than 100 years of age."

Answered by AI

Are there any available vacancies for participants in this experiment?

"Clinicaltrials.gov confirms that this medical research project is actively accepting participants; the trial was first promoted on October 24th 2017 and underwent its most recent update December 16th 2021."

Answered by AI

What outcome does this research endeavor seek to realize?

"This trial aims to assess the anti-Xa activity levels over a 24 or 36 hour period after the patient's last dose of enoxaparin. Additionally, this study plans to examine how patients' weights and ages may contribute to an increase in anti-Xa level results that exceeds one standard deviation from their mean values. Finally, investigators will attempt to discern the relationship between these measures and anti-Xa level outcomes across time."

Answered by AI

Who would be best suited to participate in this medical study?

"This clinical trial is seeking 150 individuals suffering from hemostatic disorders aged between 18 and 100. To be eligible, they must have been prescribed a treatment dose (1mg/kg twice daily or 1.5mg/kg daily) of enoxaparin at the time of presentation for elective surgery, able to accurately report the timing of their last dose and dosage taken, as well provide written consent to participate in this study."

Answered by AI

What is the common application of Enoxaparin in therapeutic treatments?

"Enoxaparin is medically recommended for treating acute chest syndrome, outpatient care and managing unstable angina."

Answered by AI

Has Enoxaparin been studied in any other research initiatives?

"Currently, 20 different clinical studies are actively evaluating the efficacy of Enoxaparin with 6 trials in Phase 3. Although Saint Louis Missouri is conducting several experiments on this drug, another 363 sites throughout the world have chosen to also participate."

Answered by AI
~16 spots leftby Apr 2025