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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (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
Overall Participants Analyzed; [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 ]

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2. Primary:

Pulmonary Embolus [ Time Frame: Within 30 days from admission to hospital ]

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3. Secondary:

Bleeding Event [ Time Frame: Within 30 days of admission to hospital ]

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4. Secondary:

Heparin Induced Thrombocytopenia [ Time Frame: Within 30 of admission to hospital ]

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  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.

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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
First Submitted:	November 14, 2012
First Posted:	November 20, 2012
Results First Submitted:	July 29, 2015
Results First Posted:	July 18, 2016
Last Update Posted:	July 18, 2016