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

NCT01729559 | Completed Phase 4 Results DMC

• 1 other identifier: IRB-12-5973
• Study Type: interventional
• Target: 495
• Locations: 1 country
• Sites: 1

Brief Summary

The rate of venous thromboembolic events in trauma patients at high risk for deep vein thrombosis and pulmonary embolism receiving low dose unfractionated heparin every 8 hours will be equivalent or less than a similar group of patients given a standard every 12 hour dose of low molecular weight heparin.

Conditions

Venous Thromboembolic Disease; Deep Vein Thrombosis; Pulmonary Embolism

Keywords

venous thromboembolic disease; deep vein thrombosis; pulmonary embolism; trauma; antithrombotic prophylaxis

Outcome Measures

Primary Outcomes (2)

• Lower Extremity Deep Vein Thrombosis

  Patients will have a bilateral lower extremity duplex ultrasound performed by a registered vascular technologist twice per week if the patient is in the ICU, or once per week if the patient is on the trauma ward. All of the deep veins from the external iliac to and including the calf veins will be interrogated. Diagnosis of deep vein thrombosis (DVT) will be defined as absence of complete vein compressibility, presence of an echogenic thrombus within the vein, absence of color flow characteristics including lack of spontaneity, phasicity, pulsatility and augmentability as noted in the clinical practice guidelines of the American Thoracic Society. The vascular technologist and physician reading the ultrasound study will be blinded to the patient's enrollment status and randomization arm/medication group.

  Within 30 days of hospital admission

• Pulmonary Embolus

  Patients with any or all of the following signs and symptoms suggestive of pulmonary embolism will have a CT angiogram (CTA) performed for diagnosis: Sudden onset of dyspnea, deterioration of existing dyspnea, decreased oxygen saturation (\<92%), onset of pleuritic chest pain without another apparent cause, onset of tachycardia (\>100), evidence of hypoxemia, hypocapnia, or respiratory alkalosis on arterial blood gas, or electrocardiographic changes reflecting right ventricular strain.

  Within 30 days from admission to hospital

Secondary Outcomes (2)

• Bleeding Event

  Within 30 days of admission to hospital

• Heparin Induced Thrombocytopenia

  Within 30 of admission to hospital

Study Arms (2)

5000 Units unfractionated Heparin Q 8 hr

EXPERIMENTAL

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

Drug: 5000 Units unfractionated Heparin Q 8 hr

30mg enoxaparin Q12 hr

ACTIVE COMPARATOR

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.

Drug: 30mg enoxaparin Q12 hr

Interventions

5000 Units unfractionated Heparin Q 8 hr DRUG

Venous thromboembolic prophylaxis medication

Also known as: LDUH

5000 Units unfractionated Heparin Q 8 hr

30mg enoxaparin Q12 hr DRUG

Venous thromboembolic prophylaxis

Also known as: Lovenox, LMWH, enoxaparin

30mg enoxaparin Q12 hr

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to Scripps Mercy Trauma Service
• ≥18 Years old
• Stratified to either Significant or Highest risk of VTE by ACCP guidelines

You may not qualify if:

• Estimated Injury Severity Score (ISS) ≤9
• Likely to be discharged before hospital day 7
• Systemic coagulopathy defined with an International Normalized Ratio (INR) of ≥1.2
• Body Mass Index (BMI) \>40
• Likely to Survive for \<7 Days
• Pregnancy
• Evidence of renal insufficiency (Cr ≥1.3)
• Delayed transfer to this facility (\>24 hrs)
• Prisoners

Sponsors & Collaborators

• Scripps Health: lead

Study Sites (1)

Scripps Mercy Hospital

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism; Wounds and Injuries

Interventions

Enoxaparin; Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Limitations and Caveats

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.

Results Point of Contact

• Title: Steven R. Shackford, MD
• Organization: Scripps Mercy Hospital

shackford.steven@scrippshealth.org

619-299-2600

Study Officials

• Steven R Shackford, MD

  Scripps Mercy Hospital, Department of Trauma Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 20, 2012
• Study Start: November 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 18, 2016
• Results First Posted: July 18, 2016

Record last verified: 2016-06

Locations

US (1)