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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 : January 29, 2021
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 compare aspirin versus low-molecular weight heparin (LMWH) (Enoxaparin) as a thromboprophylaxis in patients who sustain a fracture.

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

Detailed Description:
Patients who sustain orthopaedic trauma are at an increased risk of venous thromboembolism (VTE), including fatal pulmonary embolism (PE). Current guidelines recommend low-molecular-weight heparin (LMWH) for VTE prophylaxis in orthopaedic trauma patients. However, emerging literature in total joint arthroplasty patients suggests the potential clinical benefits of VTE prophylaxis with aspirin. This trial aims to determine if aspirin is non-inferior to LMWH for thromboprophylaxis in fracture patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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 : September 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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. All-cause mortality [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Cause-specific death [ Time Frame: 90 days ]
  2. Non-fatal pulmonary embolism [ Time Frame: 90 days ]
  3. Deep vein thrombosis [ Time Frame: 90 days ]
  4. Bleeding complication [ Time Frame: 90 days ]
  5. Wound complication [ Time Frame: 90 days ]
  6. Deep surgical site infection [ Time Frame: 90 days ]


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:

• Patients who have a planned operative or non-operative pelvis or acetabular fracture, or any operative extremity fracture proximal to the metatarsals or carpals.

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 VTE 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
  • Patients who have a known COVID-19 diagnosis prior to fracture treatment or within 3 months of the index fracture.

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: January 29, 2021
Last Verified: January 2021

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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
Enoxaparin
Heparin, Low-Molecular-Weight
Tinzaparin
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