- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03212365
Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery
August 31, 2020 updated by: Christopher Pannucci, University of Utah
Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery Patients Randomized to Different Postoperative Anticoagulant Regimens
Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures.
Thus, plastic & reconstructive surgery patients are among those at highest risk for anticoagulant-associated bleeding adverse drug events (ADEs).
This study seeks to optimize both the safety and effectiveness of post-operative enoxaparin by comparing aFXa levels, bleeding events, and VTE events among plastic & reconstructive surgery patients randomized to receive two different enoxaparin dose regimens.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures.
Thus, plastic & reconstructive surgery patients are among those at highest risk for anticoagulant-associated bleeding adverse drug events (ADEs).
Our preliminary data has shown that a fixed, or "one size fits all" dose of enoxaparin, an anticoagulant, can allow a high proportion of patients to have appropriately thinned blood, measured by anti-Factor Xa (aFXa) levels.
Patients with adequate aFXa levels are known to have significantly decreased venous thromboembolism risk (VTE), which is desirable.
However, 30% of patients who receive fixed dose enoxaparin have blood that is too thin.
Patients who are over-anticoagulated are significantly more likely to have ADEs including bleeding requiring return to the operating room, need for blood transfusion, or death.
The optimal way to dose enoxaparin to minimize ADEs remains unknown.
This study seeks to optimize both the safety and effectiveness of post-operative enoxaparin by comparing aFXa levels, bleeding events, and VTE events among plastic & reconstructive surgery patients randomized to receive two different enoxaparin dose regimens.
Study Type
Interventional
Enrollment (Actual)
295
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University
-
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Utah
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Salt Lake City, Utah, United States, 84132
- University of Utah
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- receiving plastic and reconstructive surgery under general anesthesis
- Expected post-operative stay of 2 days or more
Exclusion Criteria:
- Contraindication to use of enoxaparin
- intracranial bleeding/stroke
- Hematoma or bleeding disorder
- Heparin-induced thrmbocytopenia positive
- Creatinine clearance less than or equal to 30 mL/min
- Serum creatinine greater than 1.6 mg/dL
- epidural anesthesia
- patients placed on non-enoxaparin chemoprophylaxis regimens
- gross weight exceeding 150kg
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Fixed Dose
Participants will receive 40 mg enoxaparin twice daily
|
Participants will receive 40 mg enoxaparin twice daily
|
Experimental: Variable Dose
Participants will receive 0.5mg/kg enoxaparin twice daily
|
Participants will receive 0.5mg/kg enoxaparin twice daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Avoidance of Under-anticoagulation (Peak aFXa <0.2 IU/mL)
Time Frame: Four hours following third enoxaparin dose
|
Avoidance of under-anticoagulation (peak aFXa <0.2 IU/mL)
|
Four hours following third enoxaparin dose
|
Avoidance of Over-anticoagulation (Peak aFXa >0.4 IU/mL)
Time Frame: Four hours following third enoxaparin dose
|
Avoidance of over-anticoagulation (peak aFXa >0.4 IU/mL)
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Four hours following third enoxaparin dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Venous Thromboembolism Events
Time Frame: 90 days
|
Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery
|
90 days
|
Percentage of Patients With Bleeding Events
Time Frame: 90 days
|
Bleeding events requiring alteration in the course of care within 90 days of surgery
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher Puccini, MD, University of Utah
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 3, 2017
Primary Completion (Actual)
June 2, 2019
Study Completion (Actual)
October 1, 2019
Study Registration Dates
First Submitted
July 6, 2017
First Submitted That Met QC Criteria
July 7, 2017
First Posted (Actual)
July 11, 2017
Study Record Updates
Last Update Posted (Actual)
September 16, 2020
Last Update Submitted That Met QC Criteria
August 31, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100416
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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