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A Different Approach to Preventing Thrombosis (ADAPT)

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ClinicalTrials.gov Identifier: NCT02774265
Recruitment Status : Completed
First Posted : May 17, 2016
Results First Posted : July 24, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Deborah Stein, University of Maryland

Brief Summary:
The purpose of this study is to perform a pragmatic randomized controlled trial to compare the use of low molecular weight heparin (LMWH, lovenox, enoxaparin) versus acetylsalicylic acid (ASA) for venous thromboembolism (VTE) prophylaxis in patients with high-risk lower extremity fractures.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Pulmonary Embolism Drug: VTE prophylaxis with Enoxaparin 30mg BID Drug: VTE prophylaxis with Aspirin 81mg BID Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 329 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Different Approach to Preventing Thrombosis (ADAPT): A Randomized Controlled Trial Comparing Low Molecular Weight Heparin to Acetylsalicylic Acid in Orthopedic Trauma Patients
Actual Study Start Date : January 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: VTE prophylaxis with Enoxaparin 30mg BID
The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID.
Drug: VTE prophylaxis with Enoxaparin 30mg BID
Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.
Other Names:
  • Lovenox
  • Low Molecular Weight Heparin (LMWH)

Active Comparator: VTE prophylaxis with Aspirin 81mg BID
The group receiving VTE prophylaxis with ASA 81mg PO BID
Drug: VTE prophylaxis with Aspirin 81mg BID
Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.
Other Name: ASA (Acetylsalicylic Acid)




Primary Outcome Measures :
  1. Number of Participants With Treatment-related Bleeding Events as Assessed by the Need for Blood Transfusions and Procedures for Bleeding Complications After Initiation of the Study Medication. [ Time Frame: 90 days ]
    Includes a greater than 2g/dL drop in hemoglobin, blood transfusion, hematoma evacuation, re-operation for a deep surgical site infection or minor procedure for bleeding and GI bleed


Secondary Outcome Measures :
  1. Number of Participants With Deep Venous Thromboembolism [ Time Frame: 90 days ]
    DVT and how the diagnosis was made will be recorded. The number of events in participants in each arm will be compared to evaluate efficacy.

  2. Number of Participants With Pulmonary Embolism Events [ Time Frame: 90 days ]
    Bases on imaging obtained for symptoms.



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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:

  • All patients treated at a level-1 trauma center with any one or more of the following injuries: Pelvis fracture (operative or non-operative), Acetabulum fracture (operative or non-operative), or any operative extremity fracture (proximal to metatarsals/carpals)
  • Age greater than or equal to 18 years old

Exclusion Criteria:

  • Patients receiving pre-existing confounding prophylaxis or therapeutic anticoagulation (not to include anti-platelet agents) prior to admission or those receiving greater than one dose of LMWH since injury
  • Patients with pre-existing coagulopathy
  • Patients with a previous history of VTE within the last 6 months
  • Patients who are pregnant
  • Patients with CNS or spinal cord injury with potential need for further neurosurgical intervention precluding anticoagulation with aspirin
  • Patients with active bleeding precluding the use of anticoagulation
  • Impaired creatinine clearance <30ml/min at the time of randomization
  • History of Heparin Induced Thrombocytopenia or ASA or NSAID allergy
  • Prisoners
  • Non-english speaking patients
  • Patients who have an indication for therapeutic anticoagulation
  • Patients deemed inappropriate for inclusion in the study by their treating physician. Reason must be documented
  • Patients who would not normally receive VTE prophylaxis for their injury

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): NCT02774265


Locations
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Deborah Stein, MD, MPH R. Adams Cowley Shock Trauma Center
  Study Documents (Full-Text)

Documents provided by Deborah Stein, University of Maryland:

Publications:

Responsible Party: Deborah Stein, Professor of Surgery, Chief of Trauma, University of Maryland
ClinicalTrials.gov Identifier: NCT02774265     History of Changes
Other Study ID Numbers: HP-00065750
First Posted: May 17, 2016    Key Record Dates
Results First Posted: July 24, 2018
Last Update Posted: August 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be shared as aggregate data only to protect the identity of individual participants.

Keywords provided by Deborah Stein, University of Maryland:
Fracture
Prophylaxis

Additional relevant MeSH terms:
Aspirin
Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
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