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

Venous Thromboembolism Clinical Trial

Official title:

Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery Patients Randomized to Different Postoperative Anticoagulant Regimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212365
• Other study ID #: 100416
• Status: Completed
• Phase: Phase 2
• Start date: July 3, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: August 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: October 1, 2019
• Est. primary completion date: June 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Drug-Related Side Effects and Adverse Reactions
• Pulmonary Embolism
• Pulmonary Embolus
• Reconstructive Surgery
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Drug:
• Fixed dose
Participants will receive 40 mg enoxaparin twice daily
• Variable dose
Participants will receive 0.5mg/kg enoxaparin twice daily

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percentage of Participants With Venous Thromboembolism Events	Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery	90 days
Secondary	Percentage of Patients With Bleeding Events	Bleeding events requiring alteration in the course of care within 90 days of surgery	90 days