PREVENT CLOT: PREVENTion of Clot in Orthopaedic Trauma

Sponsor

Major Extremity Trauma Research Consortium (Other)

Overall Status

Completed

CT.gov ID

NCT02984384

Collaborator

Patient-Centered Outcomes Research Institute (Other)

12,211

Enrollment

Locations

Arms

57.9

Actual Duration (Months)

581.5

Patients Per Site

10.1

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

12211 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 :

Apr 24, 2017

Actual Primary Completion Date :

Feb 18, 2022

Actual Study Completion Date :

Feb 18, 2022

Arms and Interventions

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 Names: 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 Names: 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 Names:

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 Names:

Aspirin

Outcome Measures

Primary Outcome Measures

All-cause mortality [90 days]

Secondary Outcome Measures

Cause-specific death [90 days]
Non-fatal pulmonary embolism [90 days]
Deep vein thrombosis [90 days]
Bleeding complication [90 days]
Wound complication [90 days]
Deep surgical site infection [90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona	Tucson	Arizona	United States	85724
2	University of Miami Ryder Trauma Center	Miami	Florida	United States	33136
3	Methodist Hospital	Indianapolis	Indiana	United States	46202
4	University of Maryland R Adams Cowley Shock Trauma Center	Baltimore	Maryland	United States	21201
5	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
6	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
7	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
8	Carolinas Medical Center	Charlotte	North Carolina	United States	28204
9	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	United States	27157
10	MetroHealth Medical Center	Cleveland	Ohio	United States	44109
11	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
12	Rhode Island Hospital, Brown University	Providence	Rhode Island	United States	02903
13	University of Tennessee, RegionOne Medical Center	Memphis	Tennessee	United States	38103
14	Vanderbilt Medical Center	Nashville	Tennessee	United States	37232
15	University of Texas Health Science Center at Houston	Houston	Texas	United States	77030
16	San Antonio Military Medical Center	San Antonio	Texas	United States	78219
17	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042
18	Harborview Medical Center	Seattle	Washington	United States	98104
19	University of Wisconsin	Madison	Wisconsin	United States	53705
20	University of Calgary, Foothills Medical Centre	Calgary	Alberta	Canada
21	McMaster University, Hamilton General Hospital	Hamilton	Ontario	Canada

Sponsors and Collaborators

Major Extremity Trauma Research Consortium
Patient-Centered Outcomes Research Institute

Investigators

Principal Investigator: Robert O'Toole, MD, University of Maryland
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