Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 40 of 56 for:    "Lung Disease" | "Dalteparin"

Enoxaparin Metabolism in Reconstructive Surgery Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02411292
Recruitment Status : Completed
First Posted : April 8, 2015
Results First Posted : September 13, 2017
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Christopher Pannucci, University of Utah

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Venous Thromboembolism
Deep Venous Thrombosis
Pulmonary Embolus
Reconstructive Surgery
Intervention Drug: Enoxaparin
Enrollment 110
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Enoxaparin Metabolism
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 110
Completed 89
Not Completed 21
Reason Not Completed
Discharged before 3rd enoxaparin dose             16
Death             2
Lost to Follow-up             3
Arm/Group Title Enoxaparin Metabolism
Hide Arm/Group Description

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 Number of Baseline Participants 94
Hide Baseline Analysis Population Description
The sixteen participants that were discharged before the third enoxaparin dose were excluded from the analysis.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 94 participants
52.6
(21 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants
Female
51
  54.3%
Male
43
  45.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 94 participants
White
79
  84.0%
African American
1
   1.1%
Native American or Alaskan Native
4
   4.3%
Hispanic or Latino
9
   9.6%
Pacific Islander
1
   1.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 94 participants
94
Body Mass Index  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 94 participants
28.6
(17 to 49.8)
Gross weight  
Mean (Full Range)
Unit of measure:  Lbs
Number Analyzed 94 participants
184
(94 to 320)
Number of patients receiving treatment for Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants
8
   8.5%
Creatinine  
Mean (Full Range)
Unit of measure:  mg/dL
Number Analyzed 94 participants
0.82
(0.34 to 1.52)
Current smoker  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants
14
  14.9%
Caprini Score   [1] 
Median (Full Range)
Unit of measure:  Scores on a scale
Number Analyzed 94 participants
7
(2 to 15)
[1]
Measure Description:

The Caprini risk score is a risk assessment tool for the occurrence of venous thromboembolism (VTE) among surgical patients. The Caprini risk score includes 40 factors, each ascribed points ranging from 1 to 5. The Caprini score is calculated by adding the scores of all factors present in the patient. The minimum possible score is 0. The maximum score for men is 85. The maximum score for women is 88. The Caprini score is interpreted in the following way:

Score 0-1: Low risk of VTE

Score 2: Moderate of VTE

Score 3-4: High risk of VTE

Score ≥ 5: Highest risk for VTE

Location of primary operation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants
Head and neck
2
   2.1%
Breast
29
  30.9%
Chest, nonbreast
5
   5.3%
Back including pressure ulcers
26
  27.7%
Upper extremity
2
   2.1%
Lower extremity
30
  31.9%
Length of operation  
Mean (Full Range)
Unit of measure:  Minutes
Number Analyzed 94 participants
281
(23 to 996)
Total body surface area surgically injured  
Mean (Full Range)
Unit of measure:  Percentage of total body surface area
Number Analyzed 94 participants
6.1
(1 to 13)
Length of hospital stay  
Mean (Full Range)
Unit of measure:  Days
Number Analyzed 94 participants
7.6
(3 to 39)
Length of chemoprophylaxis  
Mean (Full Range)
Unit of measure:  Days
Number Analyzed 94 participants
10.3
(1 to 40)
1.Primary Outcome
Title Number of Participants With Venous Thromboembolism Events
Hide Description Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Low aFXa Level In-Range or High aFXa Level
Hide Arm/Group Description:
Patients with a low Anti-Factor Xa Level as identified after the third administration of enoxaparin
Patients with an in-range or high Anti-Factor Xa Level as identified after the third administration of enoxaparin
Overall Number of Participants Analyzed 49 39
Measure Type: Count of Participants
Unit of Measure: Participants
5
  10.2%
0
   0.0%
2.Primary Outcome
Title Number of Participants With Bleeding Events
Hide Description Bleeding events requiring alteration in the course of care within 90 days of surgery
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Enoxaparin Metabolism
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 94
Measure Type: Count of Participants
Unit of Measure: Participants
3
   3.2%
Time Frame 90 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enoxaparin Metabolism
Hide Arm/Group Description

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.

All-Cause Mortality
Enoxaparin Metabolism
Affected / at Risk (%)
Total   2/110 (1.82%)    
Show Serious Adverse Events Hide Serious Adverse Events
Enoxaparin Metabolism
Affected / at Risk (%) # Events
Total   2/110 (1.82%)    
General disorders   
Death *  2/110 (1.82%)  2
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enoxaparin Metabolism
Affected / at Risk (%) # Events
Total   8/110 (7.27%)    
Vascular disorders   
Deep venous thrombosis *  4/110 (3.64%)  4
Pulmonary Embolism *  1/110 (0.91%)  1
Bleeding * [1]  3/110 (2.73%)  3
*
Indicates events were collected by non-systematic assessment
[1]
Bleeding events changing the course of care
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Christopher J. Pannucci, M.D., M.S.
Organization: Division of Plastic Surgery, University of Utah
Phone: 801-581-7719
EMail: christopher.pannucci@hsc.utah.edu
Layout table for additonal information
Responsible Party: Christopher Pannucci, University of Utah
ClinicalTrials.gov Identifier: NCT02411292     History of Changes
Other Study ID Numbers: IRB 00079118
First Submitted: March 30, 2015
First Posted: April 8, 2015
Results First Submitted: June 29, 2017
Results First Posted: September 13, 2017
Last Update Posted: November 16, 2018