Trial record 23 of 56 for:
"Lung Disease" | "Dalteparin"
A Different Approach to Preventing Thrombosis (ADAPT)
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| ClinicalTrials.gov Identifier: NCT02774265 |
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Recruitment Status :
Completed
First Posted : May 17, 2016
Results First Posted : July 24, 2018
Last Update Posted : September 27, 2019
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Sponsor:
University of Maryland, Baltimore
Information provided by (Responsible Party):
Deborah Stein, University of Maryland, College Park
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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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: VTE prophylaxis with Enoxaparin 30mg BID
The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID.
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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:
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Active Comparator: VTE prophylaxis with Aspirin 81mg BID
The group receiving VTE prophylaxis with ASA 81mg PO BID
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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 :
- 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 :
- 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.
- 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, Baltimore
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, College Park:
Documents provided by Deborah Stein, University of Maryland, College Park:
Study Protocol and Statistical Analysis Plan [PDF] July 26, 2018
Publications:
| Responsible Party: | Deborah Stein, Professor of Surgery, Chief of Trauma, University of Maryland, College Park |
| 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: | September 27, 2019 |
| Last Verified: | September 2019 |
| 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, College Park:
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Fracture Prophylaxis |
Additional relevant MeSH terms:
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Lung Diseases Dalteparin Pulmonary Embolism Thrombosis Thromboembolism Embolism Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Respiratory Tract Diseases Aspirin Heparin Heparin, Low-Molecular-Weight 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 |