Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery

NCT03212365 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 100416
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Venous Thromboembolism; Deep Venous Thrombosis; Pulmonary Embolus; Reconstructive Surgery

Outcome Measures

Primary Outcomes (2)

• Avoidance of Under-anticoagulation (Peak aFXa <0.2 IU/mL)

  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)

  Avoidance of over-anticoagulation (peak aFXa \>0.4 IU/mL)

  Four hours following third enoxaparin dose

Secondary Outcomes (2)

• Percentage of Participants With Venous Thromboembolism Events

  90 days

• Percentage of Patients With Bleeding Events

  90 days

Study Arms (2)

Fixed Dose

OTHER

Participants will receive 40 mg enoxaparin twice daily

Drug: Fixed dose

Variable Dose

EXPERIMENTAL

Participants will receive 0.5mg/kg enoxaparin twice daily

Drug: Variable dose

Interventions

Fixed dose DRUG

Participants will receive 40 mg enoxaparin twice daily

Fixed Dose

Variable dose DRUG

Participants will receive 0.5mg/kg enoxaparin twice daily

Variable Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• receiving plastic and reconstructive surgery under general anesthesis
• Expected post-operative stay of 2 days or more

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Stanford University: collaborator

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• Pannucci CJ, Fleming KI, Varghese TK Jr, Stringham J, Huang LC, Pickron TB, Prazak AM, Bertolaccini C, Momeni A. Low Anti-Factor Xa Level Predicts 90-Day Symptomatic Venous Thromboembolism in Surgical Patients Receiving Enoxaparin Prophylaxis: A Pooled Analysis of Eight Clinical Trials. Ann Surg. 2022 Dec 1;276(6):e682-e690. doi: 10.1097/SLA.0000000000004589. Epub 2020 Oct 19.

  PMID: 33086312 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism

Results Point of Contact

• Title: Christopher Pannucci, MD
• Organization: University of Utah

christopher.pannucci@hsc.utah.edu

801 581 2121

Study Officials

• Christopher Puccini, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 11, 2017
• Study Start: July 3, 2017
• Primary Completion: June 2, 2019
• Study Completion: October 1, 2019
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-08

Locations

US (2)