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PREVENTion of Clot in Orthopaedic Trauma (PREVENT CLOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02984384
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Major Extremity Trauma Research Consortium

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.

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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


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




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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

Locations
Show Show 21 study locations
Sponsors and Collaborators
Major Extremity Trauma Research Consortium
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Robert O'Toole, MD University of Maryland, College Park
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Major Extremity Trauma Research Consortium
ClinicalTrials.gov Identifier: NCT02984384    
Other Study ID Numbers: PCS-1511-32745
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019

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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:
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Thrombosis
Wounds and Injuries
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