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 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Blood Clot Trauma||Drug: Acetylsalicylic acid Drug: Low Molecular Weight Heparin (LMWH)||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12980 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Death [ Time Frame: 3 months ]Number of death and relatedness of death to a pulmonary embolism.
- Clinically important pulmonary embolism [ Time Frame: 3 months ]Detected pulmonary embolism that are life threatening or symptom causing.
- 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
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
|Contact: Tara Taylor, MPHfirstname.lastname@example.org|
|Contact: Nathan O'Hara, MHAemail@example.com|
|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|