PREVENTion of Clot in Orthopaedic Trauma

Trauma Clinical Trial

— PREVENT CLOT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02984384
• Other study ID #: PCS-1511-32745
• Status: Completed
• Phase: Phase 3
• Start date: April 24, 2017
• Est. completion date: February 18, 2022

Study information

• Verified date: April 2024
• Source: Major Extremity Trauma Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12424
• Est. completion date: February 18, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

• Patients at increased risk of blood clot(s) from their orthopaedic injury(ies) and will receive prophylactic blood thinner regimen per standard of care.

• Patients 18 years or older.

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

• Prisoners

• Patients who do not speak either English or Spanish

• Patients who are likely to have severe problems maintaining follow-up

• Patients, based upon the clinical judgment of the treating clinician, NOT equally suited for treatment with either aspirin or low-molecular-weight heparin

• 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

Related Conditions & MeSH terms

• Blood Clot
• Thrombosis
• Trauma
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	University of Calgary, Foothills Medical Centre	Calgary	Alberta
Canada	McMaster University, Hamilton General Hospital	Hamilton	Ontario
United States	University of Maryland R Adams Cowley Shock Trauma Center	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Methodist Hospital	Indianapolis	Indiana
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Wisconsin	Madison	Wisconsin
United States	University of Tennessee, RegionOne Medical Center	Memphis	Tennessee
United States	University of Miami Ryder Trauma Center	Miami	Florida
United States	Vanderbilt Medical Center	Nashville	Tennessee
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital, Brown University	Providence	Rhode Island
United States	San Antonio Military Medical Center	San Antonio	Texas
United States	Harborview Medical Center	Seattle	Washington
United States	University of Arizona	Tucson	Arizona
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Major Extremity Trauma Research Consortium	Patient-Centered Outcomes Research Institute

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

O'Toole RV, Stein DM, Frey KP, O'Hara NN, Scharfstein DO, Slobogean GP, Taylor TJ, Haac BE, Carlini AR, Manson TT, Sudini K, Mullins CD, Wegener ST, Firoozabadi R, Haut ER, Bosse MJ, Seymour RB, Holden MB, Gitajn IL, Goldhaber SZ, Eastman AL, Jurkovich GJ, Vallier HA, Gary JL, Kleweno CP, Cuschieri J, Marvel D, Castillo RC; METRC. PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT): a randomised pragmatic trial protocol comparing aspirin versus low-molecular-weight heparin for blood clot prevention in orthopaedic trauma patients. BMJ Open. 2021 Mar 24;11(3):e041845. doi: 10.1136/bmjopen-2020-041845. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With All-cause Mortality	Death from any cause	90 days
Secondary	Number of Participants With Cause-specific Death	Cause specific death. Some participants are reported twice if reason for death met more than one category.	90 days
Secondary	Non-fatal Pulmonary Embolism		90 days
Secondary	Deep Vein Thrombosis		90 days
Secondary	Bleeding Complication		90 days
Secondary	Wound Complication		90 days
Secondary	Deep Surgical Site Infection		90 days