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PREVENTion of Clot in Orthopaedic Trauma (PREVENT CLOT)

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ClinicalTrials.gov Identifier: NCT02984384
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Blood Clot Trauma Drug: Acetylsalicylic acid Drug: Low Molecular Weight Heparin (LMWH) Phase 3

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12980 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Low Molecular Weight Heparin (LMWH)-Enoxaparin
Injection of 30 mg enoxaparin, twice a day via injection
Drug: Low Molecular Weight Heparin (LMWH)
The LMWH intervention will be 30 mg enoxaparin subcutaneous (under the skin) twice a day with variations in dosing allowed, per the standard of care at sites, as needed for patients who are very obese or exhibit renal dysfunction.
Other Name: Enoxaparin
Active Comparator: Acetylsalicylic acid (ASA)-Aspirin
Enteral ingestion or administration of 81 mg ASA, twice a day
Drug: Acetylsalicylic acid
The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.
Other Name: Aspirin


Outcome Measures

Primary Outcome Measures :
  1. Death [ Time Frame: 3 months ]
    Number of death and relatedness of death to a pulmonary embolism.

  2. Clinically important pulmonary embolism [ Time Frame: 3 months ]
    Detected pulmonary embolism that are life threatening or symptom causing.

  3. Complications [ Time Frame: 3 months ]

    Complications associated with trauma and trauma treatment:

    • Wound drainage, hematoma or seroma of an orthopaedic injury requiring reoperation
    • Diagnosis of deep surgical site infection of an orthopaedic injury requiring operation.
    • Diagnosis of a deep surgical site infection of an orthopaedic injury, not requiring operation
    • Clinically overt bleed with a > 2g/dL drop in Hb or requiring > 2 unit transfusion
    • GI bleed
    • Other bleeding complications following study enrollment and receipt of first dose of study medication requiring procedure
    • Lower extremity deep venous thrombosis (DVT) distal to knee
    • Lower extremity or pelvic DVT proximal to knee
    • Other DVT
    • Studies ordered related to concerns for bleeding or venous thromboembolism event


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984384


Contacts
Contact: Tara Taylor, MPH 410-614-6081 ttaylo56@jhu.edu
Contact: Nathan O'Hara, MHA nohara@umoa.umm.edu

Locations
United States, Arizona
University of Arizona Not yet recruiting
Tucson, Arizona, United States, 85724
Contact: Andrea Seach       aseach@email.arizona.edu   
Principal Investigator: Christina Boulton, MD         
Principal Investigator: Bellal Joseph, MD         
United States, Florida
University of Miami Ryder Trauma Center Not yet recruiting
Miami, Florida, United States, 33136
Contact: Dinorah Rodriquez       dinorah@med.miami.edu   
Principal Investigator: Gregory Zych, MD         
Principal Investigator: Tanya Zakrison, MD         
United States, Indiana
Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lakye Deeter       lakedwar@iu.edu   
Principal Investigator: Gregory Gaski, MD         
Principal Investigator: Benjamin Zarzaur, MD         
United States, Maryland
University of Maryland R Adams Cowley Shock Trauma Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Yasmin Degani       ydegani@umoa.umm.edu   
Principal Investigator: Robert O'Toole, MD         
Principal Investigator: Deborah Stein, MD         
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Michael McTague       MMCTAGUE@PARTNERS.ORG   
Principal Investigator: Michael Weaver, MD         
Principal Investigator: George Velmahos, MD         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Josie Hydrick       jhydrick@umc.edu   
Principal Investigator: Partrick Bergin, MD         
Principal Investigator: Matthew Kutcher, MD         
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Daniel Ressler       Daniel.R.Ressler@hitchcock.org   
Principal Investigator: Leah Gitajn, MD         
Principal Investigator: Kurt Rhynhart, MD         
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Rachel Seymour, PhD       Rachel.Seymour@carolinashealthcare.org   
Principal Investigator: Michael Bosse, MD         
Principal Investigator: Ashley Christmas, MD         
Wake Forest University Baptist Medical Center Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Martha Holden       mholden@wakehealth.edu   
Principal Investigator: Eben Carroll, MD         
Principal Investigator: Preston Miller, MD         
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Mary Breslin       mbreslin@metrohealth.org   
Contact: Joanne Fraifogl       jfraifogl@metrohealth.org   
Principal Investigator: Heather Vallier, MD         
Principal Investigator: Jeffery Claridge, MD         
United States, Rhode Island
Rhode Island Hospital, Brown University Recruiting
Providence, Rhode Island, United States, 02903
Contact: Mary Jean Crisco       mjcrisco@universityorthopedics.com   
Principal Investigator: Roman Hayda, MD         
Principal Investigator: Stephanie Lueckal, MD         
United States, Tennessee
University of Tennessee, RegionOne Medical Center Not yet recruiting
Memphis, Tennessee, United States, 38103
Contact: Lynda Waddle-Smith       lwaddle@uthsc.edu   
Principal Investigator: John Weinlein, MD         
Principal Investigator: Martin Croce, MD         
Vanderbilt Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Karen Trochez       karen.m.trochez@Vanderbilt.Edu   
Principal Investigator: William Obremskey, MD         
Principal Investigator: Oscar Guillamondegui, MD         
United States, Texas
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Matthew Galpin       Matthew.Galpin@uth.tmc.edu   
Principal Investigator: Joshua Gary, MD         
Principal Investigator: Bryan Cotton, MD         
San Antonio Military Medical Center Recruiting
San Antonio, Texas, United States, 78219
Contact: Stephanie DeLeon       stephanie.deleon.ctr@mail.mil   
Principal Investigator: Patrick Osborn, MD         
Principal Investigator: Kurt Edwards, MD         
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Julie Agel       bagel@uw.edu   
Principal Investigator: Reza Firoozabadi, MD         
Principal Investigator: Joseph Cuschieri         
Canada, Alberta
University of Calgary, Foothills Medical Centre Not yet recruiting
Calgary, Alberta, Canada
Contact: Tanja Harrison       tharriso@ucalgary.ca   
Principal Investigator: Prism Schneider, MD         
Principal Investigator: Paul McBeth, MD         
Canada, Ontario
McMaster University, Hamilton General Hospital Not yet recruiting
Hamilton, Ontario, Canada
Contact: Johal Herman, MD       hermanjohal@gmail.com   
Principal Investigator: Johal Herman, MD         
Sponsors and Collaborators
Major Extremity Trauma Research Consortium
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Robert O'Toole, MD University of Maryland
Principal Investigator: Renan Castillo, PhD Johns Hopkins Bloomberg School of Public Health
Study Director: Tara Taylor, MPH Johns Hopkins Bloomberg School of Public Health
Study Director: Katherine Frey, PhD, MPH, RN Johns Hopkins Bloomberg School of Public Health
More Information

Responsible Party: Major Extremity Trauma Research Consortium
ClinicalTrials.gov Identifier: NCT02984384     History of Changes
Other Study ID Numbers: PCS-1511-32745
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Major Extremity Trauma Research Consortium:
Trauma
Blood clot
Venous Thromboembolism
Pulmonary Embolism
Deep Vein Thrombosis
Thromboprophylaxis
Blood clot prevention
trauma patients

Additional relevant MeSH terms:
Wounds and Injuries
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Aspirin
Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticoagulants