Trial Outcomes & Findings for Enoxaparin Metabolism in Reconstructive Surgery Patients (NCT NCT02411292)

NCT ID: NCT02411292

Last Updated: 2018-11-16

Results Overview

Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 110 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2018-11-16

Participant Flow

Participant milestones

Measure	Enoxaparin Metabolism Eligible patients will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose. Enoxaparin: Enrolled patients will receive real-time monitoring of peak and trough steady state anti-Xa levels. Out-of-range patients will receive real time dose adjustment using a clinical protocol developed with our inpatient pharmacists.
Overall Study STARTED	110
Overall Study COMPLETED	89
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Measure	Enoxaparin Metabolism Eligible patients will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose. Enoxaparin: Enrolled patients will receive real-time monitoring of peak and trough steady state anti-Xa levels. Out-of-range patients will receive real time dose adjustment using a clinical protocol developed with our inpatient pharmacists.
Overall Study Discharged before 3rd enoxaparin dose	16
Overall Study Death	2
Overall Study Lost to Follow-up	3

Baseline Characteristics

Enoxaparin Metabolism in Reconstructive Surgery Patients

Baseline characteristics by cohort

Measure	Enoxaparin Metabolism n=94 Participants Eligible patients will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose. Enoxaparin: Enrolled patients will receive real-time monitoring of peak and trough steady state anti-Xa levels. Out-of-range patients will receive real time dose adjustment using a clinical protocol developed with our inpatient pharmacists.
Age, Continuous	52.6 years n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · White	79 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Native American or Alaskan Native	4 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	9 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Pacific Islander	1 Participants n=5 Participants
Region of Enrollment United States	94 participants n=5 Participants
Body Mass Index	28.6 kg/m^2 n=5 Participants
Gross weight	184 lbs n=5 Participants
Number of patients receiving treatment for Diabetes	8 Participants n=5 Participants
Creatinine	0.82 mg/dL n=5 Participants
Current smoker	14 Participants n=5 Participants
Caprini Score	7 scores on a scale n=5 Participants
Location of primary operation Head and neck	2 Participants n=5 Participants
Location of primary operation Breast	29 Participants n=5 Participants
Location of primary operation Chest, nonbreast	5 Participants n=5 Participants
Location of primary operation Back including pressure ulcers	26 Participants n=5 Participants
Location of primary operation Upper extremity	2 Participants n=5 Participants
Location of primary operation Lower extremity	30 Participants n=5 Participants
Length of operation	281 minutes n=5 Participants
Total body surface area surgically injured	6.1 percentage of total body surface area n=5 Participants
Length of hospital stay	7.6 days n=5 Participants
Length of chemoprophylaxis	10.3 days n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Population: Patients with out-of-range levels or missing levels were dropped from relevant analyses. Of the 89 participants who completed the study, 88 had peak steady-state anti-factor Xa levels to be analyzed.

Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery

Outcome measures

Measure	Low aFXa Level n=49 Participants Patients with a low Anti-Factor Xa Level as identified after the third administration of enoxaparin	In-Range or High aFXa Level n=39 Participants Patients with an in-range or high Anti-Factor Xa Level as identified after the third administration of enoxaparin
Number of Participants With Venous Thromboembolism Events	5 Participants	0 Participants

PRIMARY outcome

Timeframe: 90 days

Population: Bleeding events are reported for the 94 who were not discharged prior to the third Enoxaparin dose. Because two bleeding events occurred prior to the drawing of labs, they cannot be classified into low vs. in-range/high enoxaparin levels. Because of this, reporting on bleeding events is reported across the whole study population and not by arm.

Bleeding events requiring alteration in the course of care within 90 days of surgery

Outcome measures

Measure	Low aFXa Level n=94 Participants Patients with a low Anti-Factor Xa Level as identified after the third administration of enoxaparin	In-Range or High aFXa Level Patients with an in-range or high Anti-Factor Xa Level as identified after the third administration of enoxaparin
Number of Participants With Bleeding Events	3 Participants	—

Adverse Events

Enoxaparin Metabolism

Serious events: 2 serious events

Other events: 8 other events

Deaths: 2 deaths

Serious adverse events

Measure

Enoxaparin Metabolism n=110 participants at risk Eligible patients will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose. Enoxaparin: Enrolled patients will receive real-time monitoring of peak and trough steady state anti-Xa levels. Out-of-range patients will receive real time dose adjustment using a clinical protocol developed with our inpatient pharmacists.

General disorders Death

1.8% 2/110 • Number of events 2 • 90 days

Other adverse events

Measure	Enoxaparin Metabolism n=110 participants at risk Eligible patients will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose. Enoxaparin: Enrolled patients will receive real-time monitoring of peak and trough steady state anti-Xa levels. Out-of-range patients will receive real time dose adjustment using a clinical protocol developed with our inpatient pharmacists.
Vascular disorders Deep venous thrombosis	3.6% 4/110 • Number of events 4 • 90 days
Vascular disorders Pulmonary Embolism	0.91% 1/110 • Number of events 1 • 90 days
Vascular disorders Bleeding	2.7% 3/110 • Number of events 3 • 90 days

Additional Information

Dr. Christopher J. Pannucci, M.D., M.S.

Division of Plastic Surgery, University of Utah

Phone: 801-581-7719

Email: christopher.pannucci@hsc.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place