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Venous Thromboembolic Prophylaxis After Trauma: Three Times a Day Unfractionated Heparin Versus Twice a Day Enoxaparin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Scripps Health
ClinicalTrials.gov Identifier:
NCT01729559
First received: November 14, 2012
Last updated: June 7, 2016
Last verified: June 2016
History of Changes
Results First Received: July 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Venous Thromboembolic Disease
Deep Vein Thrombosis
Pulmonary Embolism
Interventions: Drug: 5000 Units unfractionated Heparin Q 8 hr
Drug: 30mg enoxaparin Q12 hr

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From November 15, 2012 through September 15, 2014, consecutively admitted adult trauma patients were evaluated for eligibility for the study. Patients aged 18 years and older and at risk for Venous thromboembolic event (VTE) based on the American College of Chest Physicians guidelines were included.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Those with an estimated Injury Severity Score (ISS) equal to or less than 9, those expected to have a hospital length of stay less than seven days by reason of discharge or death, and prisoners were excluded.

Reporting Groups
  Description
5000 Units Unfractionated Heparin Q 8 Hours

Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.

5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned.
30mg Enoxaparin Q12 Hours

Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.

30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis

Participant Flow:   Overall Study
    5000 Units Unfractionated Heparin Q 8 Hours     30mg Enoxaparin Q12 Hours  
STARTED     251     244  
COMPLETED     220     216  
NOT COMPLETED     31     28  
Protocol Violation                 31                 28  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Basic demographic and clinical characteristics of trauma patients who met all inclusion criteria.

Reporting Groups
  Description
5000 Units Unfractionated Heparin Q 8 Hours

Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.

5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned.
30mg Enoxaparin Q12 Hours

Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.

30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis
Total Total of all reporting groups

Baseline Measures
    5000 Units Unfractionated Heparin Q 8 Hours     30mg Enoxaparin Q12 Hours     Total  
Number of Participants  
[units: participants]
 		  220     216     436  
Age  
[units: years]
Mean (Standard Deviation) 		  46.5  (21.2)     46.4  (20.8)     46.4  (21.0)  
Gender  
[units: participants]
 		     
Female     60     64     124  
Male     160     152     312  
Region of Enrollment  
[units: participants]
 		     
United States     220     216     436  
Body Mass Index  
[units: kg/m^2]
Mean (Standard Deviation) 		  26.1  (4.5)     26.9  (5.2)     26.5  (4.9)  
Injury Severity Score [1]
[units: units on a scale]
Median (Full Range) 		  10  
  (1 to 50)   		  9  
  (1 to 38)   		  9  
  (1 to 50)  
[1] The Injury Severity Score (ISS) is an anatomical scoring system that provides an overall score for patients with multiple injuries. Each injury is assigned an Abbreviated Injury Scale (AIS) score allocated to one of six body regions (Head, Face, Chest, Abdomen, Extremities, External). The highest AIS scores among the three most severely injured body regions are squared and added together to produce the total ISS score. The ISS score ranges from 0 to 75. Each AIS score ranges from 1 to 6 (6 denotes an unsurvivable injury).



  Outcome Measures
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1.  Primary:   Lower Extremity Deep Vein Thrombosis   [ Time Frame: Within 30 days of hospital admission ]
  Show Outcome Measure 1

2.  Primary:   Pulmonary Embolus   [ Time Frame: Within 30 days from admission to hospital ]
  Show Outcome Measure 2

3.  Secondary:   Bleeding Event   [ Time Frame: Within 30 days of admission to hospital ]
  Show Outcome Measure 3

4.  Secondary:   Heparin Induced Thrombocytopenia   [ Time Frame: Within 30 of admission to hospital ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The lack of long-term follow-up to identify VTE events among patients who were either transferred or readmitted to other facilities with VTE-related events was not performed. Published risk estimates were inaccurate for our sample size calculation.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Steven R. Shackford, MD
Organization: Scripps Mercy Hospital
phone: 619-299-2600
e-mail: shackford.steven@scrippshealth.org



Responsible Party: Scripps Health
ClinicalTrials.gov Identifier: NCT01729559     History of Changes
Other Study ID Numbers: IRB-12-5973
Study First Received: November 14, 2012
Results First Received: July 29, 2015
Last Updated: June 7, 2016
Health Authority: United States: Institutional Review Board