Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery
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ClinicalTrials.gov Identifier: NCT03212365 |
Recruitment Status :
Completed
First Posted : July 11, 2017
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Venous Thromboembolism Deep Venous Thrombosis Pulmonary Embolus Reconstructive Surgery | Drug: Fixed dose Drug: Variable dose | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 295 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Patients will be randomized into one of two groups (enoxaparin 40mg twice daily or enoxaparin 0.5mg/kg twice daily, rounded to the nearest milligram). |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Other |
Official Title: | Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery Patients Randomized to Different Postoperative Anticoagulant Regimens |
Actual Study Start Date : | July 3, 2017 |
Actual Primary Completion Date : | June 2, 2019 |
Actual Study Completion Date : | October 1, 2019 |

Arm | Intervention/treatment |
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Fixed Dose
Participants will receive 40 mg enoxaparin twice daily
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Drug: Fixed dose
Participants will receive 40 mg enoxaparin twice daily |
Experimental: Variable Dose
Participants will receive 0.5mg/kg enoxaparin twice daily
|
Drug: Variable dose
Participants will receive 0.5mg/kg enoxaparin twice daily |
- 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)
- 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)
- 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
- Percentage of Patients With Bleeding Events [ Time Frame: 90 days ]Bleeding events requiring alteration in the course of care within 90 days of surgery

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212365
United States, California | |
Stanford University | |
Stanford, California, United States, 94305 | |
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84132 |
Principal Investigator: | Christopher Puccini, MD | University of Utah |
Documents provided by Christopher Pannucci, University of Utah:
Responsible Party: | Christopher Pannucci, Assistant Professor, University of Utah |
ClinicalTrials.gov Identifier: | NCT03212365 |
Other Study ID Numbers: |
100416 |
First Posted: | July 11, 2017 Key Record Dates |
Results First Posted: | September 16, 2020 |
Last Update Posted: | September 16, 2020 |
Last Verified: | August 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Pulmonary Embolism Thrombosis Thromboembolism Venous Thromboembolism Venous Thrombosis Drug-Related Side Effects and Adverse Reactions Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Chemically-Induced Disorders Embolism Lung Diseases Respiratory Tract Diseases |