PREVENTion of Clot in Orthopaedic Trauma



Status:Recruiting
Conditions:Cardiology, Hospital
Therapuetic Areas:Cardiology / Vascular Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:5/3/2018
Start Date:April 24, 2017
End Date:June 2021
Contact:Tara Taylor, MPH
Email:ttaylo56@jhu.edu
Phone:410-614-6081

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PREVENTion of Clot in Orthopaedic Trauma (PREVENT CLOT): A Randomized Pragmatic Trial Comparing the Complications and Safety of Blood Clot Prevention Medicines Used in Orthopaedic Trauma Patients

The purpose of this study is to investigate the effectiveness of Low Molecular Weight Heparin
(LMWH) compared to Aspirin in preventing death and clinically important pulmonary blood clots
in patients who sustain trauma.

In this study the efficacy of Low Molecular Weight Heparin (LMWH) (Enoxaparin) compared to
Aspirin in the use of preventing death and clinically important blood clots in the lungs in
patients who sustain trauma will be investigated. The following comparisons between aspirin
and the LMWH are described in the specific aims below:

Specific Aim 1: Assess the proportion of patients who sustain death, clinically significant
pulmonary embolism, or complication after orthopaedic trauma treated with injectable LMWH
compared to those treated with aspirin.

Hypothesis 1a: The mortality rate will be non-inferior in the aspirin group Hypothesis 1b:
The rate of clinically significant PE will be non-inferior in the aspirin group Hypothesis
1c: The rate of complications will be superior (i.e., lower) in the aspirin group Specific
Aim 2: Assess satisfaction with care in orthopaedic trauma patients treated with injectable
LMWH compared to those treated with aspirin Hypothesis2a : Satisfaction will be superior in
the aspirin group Specific Aim 3: Document out of pocket patient costs in orthopaedic trauma
patients treated with injectable LMWH compared to those treated with aspirin Hypothesis3a :
Out of pocket costs will be lower in the aspirin group Specific Aim 4: Examine the proportion
of minor clot events that are less important to patients (clots in the proximal legs,
incidental PE) in orthopaedic trauma patients treated with injectable LMWH compared to those
treated with aspirin.

Hypothesis4a : The rate will be non-inferior in the aspirin group Specific Aim 5: Examine the
proportion of minor clot events that are less important to patients (clots in the proximal
legs, incidental PE) in orthopaedic trauma patients treated with injectable LMWH compared to
those treated with aspirin.

Hypothesis 5a: The rate will be non-inferior in the aspirin group.

Inclusion Criteria:

- Trauma patients who are at increased risk of blood clots from their orthopaedic
traumatic injury (operatively treated extremity injuries and all pelvis or acetabulum
fractures that are treated either operatively or non operatively) and for whom a
prophylactic blood thinner regimen would be standard of care at their institution.

- 18 years or older

Exclusion Criteria:

- Patients who present to the hospital more than 48 hours post injury

- Patients who received more than 2 doses of LMWH or Aspirin for initial prophylaxis

- Patients on long term blood thinners (other than low-dose aspirin or platelet
inhibitors such as Plavix or Aggrenox)

- Patients who have had a VTE within the last 6 months

- Patients on therapeutic (as opposed to prophylactic) blood thinners for an acute issue
at the time of admission

- Patients who have a newly diagnosed indication for therapeutic blood thinners (for
example vascular injury) that will require therapeutic anticoagulation for more than
one week

- Patients who cannot receive either of the study medications due to an allergy (history
of heparin induced thrombocytopenia, allergy to aspirin, or NSAIDs) or other medical
contraindication to blood thinners

- Patients who are on higher dose aspirin (>81 mg once a day or higher) for medical
reasons or who will be treated with higher dose aspirin

- Patients with underlying chronic clotting disorders (i.e. Factor V Leiden,
hyperhomocysteinemia, Protein C and S deficiency) that require full dose
anticoagulation or are a contraindication to venous thromboembolism chemoprophylaxis

- Patients with end stage renal disease or impaired creatinine clearance <30 ml/min at
time of randomization(note: creatinine clearance does not need to be documented if
prescribing physician would order medication without test as SOC)

- Pregnant or lactating patients

- Patients contraindicated for any reason for either medicine

- Prisoners

- Patients who do not speak either English or Spanish

- Patients may be excluded for other reasons at the discretion of the treating
physician; the reason for exclusion must be documented on the screening form.
We found this trial at
17
sites
San Antonio, Texas
Principal Investigator: Patrick Osborn, MD
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San Antonio, TX
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Michael Weaver, MD
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Boston, MA
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Michael Bosse, MD
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Charlotte, NC
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Joshua Gary, MD
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Houston, TX
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Partrick Bergin, MD
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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Baltimore, Maryland 21201
Principal Investigator: Robert O'Toole, MD
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Baltimore, MD
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Calgary, Alberta
Principal Investigator: Prism Schneider, MD
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Calgary,
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: Heather Vallier, MD
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Cleveland, OH
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Indianapolis, Indiana 46202
Principal Investigator: Gregory Gaski, MD
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from
Indianapolis, IN
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Leah Gitajn, MD
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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880 Madison Avenue
Memphis, Tennessee 38103
Principal Investigator: John Weinlein, MD
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Memphis, TN
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Miami, Florida 33101
Principal Investigator: Gregory Zych, MD
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Miami, FL
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Nashville, Tennessee 37212
Principal Investigator: William Obremskey, MD
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Nashville, TN
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Providence, Rhode Island 02903
Principal Investigator: Roman Hayda, MD
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Providence, RI
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Principal Investigator: Reza Firoozabadi, MD
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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Seattle, WA
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Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Christina Boulton, MD
University of Arizona The University of Arizona is a premier, public research university. Established in...
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Tucson, AZ
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Principal Investigator: Eben Carroll, MD
Wake Forest University Baptist Medical Center Welcome to Wake Forest Baptist Medical Center, a fully...
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Winston-Salem, NC
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