search
Back to results

PREVENTion of Clot in Orthopaedic Trauma (PREVENT CLOT)

Primary Purpose

Blood Clot, Trauma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Acetylsalicylic acid
Low Molecular Weight Heparin (LMWH)
Sponsored by
Major Extremity Trauma Research Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Clot focused on measuring Trauma, Blood clot, Venous Thromboembolism, Pulmonary Embolism, Deep Vein Thrombosis, Thromboprophylaxis, Blood clot prevention, trauma patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.
  • 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

Sites / Locations

  • University of Arizona
  • University of Miami Ryder Trauma Center
  • Methodist Hospital
  • University of Maryland R Adams Cowley Shock Trauma Center
  • Massachusetts General Hospital
  • University of Mississippi Medical Center
  • Dartmouth-Hitchcock Medical Center
  • Carolinas Medical Center
  • Wake Forest University Baptist Medical Center
  • MetroHealth Medical Center
  • Allegheny General Hospital
  • Rhode Island Hospital, Brown University
  • University of Tennessee, RegionOne Medical Center
  • Vanderbilt Medical Center
  • University of Texas Health Science Center at Houston
  • San Antonio Military Medical Center
  • Inova Fairfax Hospital
  • Harborview Medical Center
  • University of Wisconsin
  • University of Calgary, Foothills Medical Centre
  • McMaster University, Hamilton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low Molecular Weight Heparin (LMWH)-Enoxaparin

Acetylsalicylic acid (ASA)-Aspirin

Arm Description

Injection of 30 mg enoxaparin, twice a day via injection

Enteral ingestion or administration of 81 mg ASA, twice a day

Outcomes

Primary Outcome Measures

All-cause mortality

Secondary Outcome Measures

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

Full Information

First Posted
December 2, 2016
Last Updated
October 7, 2022
Sponsor
Major Extremity Trauma Research Consortium
Collaborators
Patient-Centered Outcomes Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT02984384
Brief Title
PREVENTion of Clot in Orthopaedic Trauma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
February 18, 2022 (Actual)
Study Completion Date
February 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Major Extremity Trauma Research Consortium
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Clot, Trauma
Keywords
Trauma, Blood clot, Venous Thromboembolism, Pulmonary Embolism, Deep Vein Thrombosis, Thromboprophylaxis, Blood clot prevention, trauma patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Molecular Weight Heparin (LMWH)-Enoxaparin
Arm Type
Active Comparator
Arm Description
Injection of 30 mg enoxaparin, twice a day via injection
Arm Title
Acetylsalicylic acid (ASA)-Aspirin
Arm Type
Active Comparator
Arm Description
Enteral ingestion or administration of 81 mg ASA, twice a day
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic acid
Other Intervention Name(s)
Aspirin
Intervention Description
The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.
Intervention Type
Drug
Intervention Name(s)
Low Molecular Weight Heparin (LMWH)
Other Intervention Name(s)
Enoxaparin
Intervention Description
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.
Primary Outcome Measure Information:
Title
All-cause mortality
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Cause-specific death
Time Frame
90 days
Title
Non-fatal pulmonary embolism
Time Frame
90 days
Title
Deep vein thrombosis
Time Frame
90 days
Title
Bleeding complication
Time Frame
90 days
Title
Wound complication
Time Frame
90 days
Title
Deep surgical site infection
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert O'Toole, MD
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Renan Castillo, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tara Taylor, MPH
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Katherine Frey, PhD, MPH, RN
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Miami Ryder Trauma Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Maryland R Adams Cowley Shock Trauma Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Rhode Island Hospital, Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
University of Tennessee, RegionOne Medical Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
San Antonio Military Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78219
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
University of Calgary, Foothills Medical Centre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
McMaster University, Hamilton General Hospital
City
Hamilton
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33762229
Citation
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.
Results Reference
background
PubMed Identifier
31604788
Citation
O'Hara NN, Degani Y, Marvel D, Wells D, Mullins CD, Wegener S, Frey K, Joseph T, Hurst J, Castillo R, O'Toole RV; PREVENT CLOT Stakeholder Committee. Which orthopaedic trauma patients are likely to refuse to participate in a clinical trial? A latent class analysis. BMJ Open. 2019 Oct 11;9(10):e032631. doi: 10.1136/bmjopen-2019-032631.
Results Reference
derived

Learn more about this trial

PREVENTion of Clot in Orthopaedic Trauma

We'll reach out to this number within 24 hrs