PREVENTion of Clot in Orthopaedic Trauma

Description

The purpose of this study is to investigate the effectiveness of Low Molecular Weight Heparin (LMWH) compared to Aspirin in preventing death and clinically important pulmonary blood clots in patients who sustain trauma.

Study Start Date

April, 24 2017

Estimated Completion Date

June 2021

Interventions

  • Drug: Acetylsalicylic acid
  • Drug: Low Molecular Weight Heparin (LMWH)

Study ID

Major Extremity Trauma Research Consortium -- PCS-1511-32745

Status

Recruiting

Trial ID

NCT02984384

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

12980

Sponsor

Major Extremity Trauma Research Consortium

Inclusion Criteria

  • Trauma patients who are at increased risk of blood clots from their orthopaedic traumatic injury (operatively treated extremity injuries and all pelvis or acetabulum fractures that are treated either operatively or non operatively) and for whom a prophylactic blood thinner regimen would be standard of care at their institution.
  • 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 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.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (85)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Michael McTague None MMCTAGUE@PARTNERS.ORG
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Michael McTague None MMCTAGUE@PARTNERS.ORG
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Michael McTague None MMCTAGUE@PARTNERS.ORG
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Michael McTague None MMCTAGUE@PARTNERS.ORG
Rhode Island Hospital Brown University - Providence, Rhode Island 41.0 miles Mary Jean Crisco None mjcrisco@universityorthopedics.com
Rhode Island Hospital Brown University - Providence, Rhode Island 41.0 miles Mary Jean Crisco None mjcrisco@universityorthopedics.com
Rhode Island Hospital Brown University - Providence, Rhode Island 41.0 miles Mary Jean Crisco None mjcrisco@universityorthopedics.com
Rhode Island Hospital Brown University - Providence, Rhode Island 41.0 miles Mary Jean Crisco None mjcrisco@universityorthopedics.com
Rhode Island Hospital Brown University - Providence, Rhode Island 41.0 miles Mary Jean Crisco None mjcrisco@universityorthopedics.com
Rhode Island Hospital Brown University - Providence, Rhode Island 41.0 miles Mary Jean Crisco None mjcrisco@universityorthopedics.com
DartmouthHitchcock Medical Center - Lebanon, New Hampshire 105.5 miles Daniel Ressler None Daniel.R.Ressler@hitchcock.org
DartmouthHitchcock Medical Center - Lebanon, New Hampshire 105.5 miles Daniel Ressler None Daniel.R.Ressler@hitchcock.org
DartmouthHitchcock Medical Center - Lebanon, New Hampshire 105.5 miles Daniel Ressler None Daniel.R.Ressler@hitchcock.org
DartmouthHitchcock Medical Center - Lebanon, New Hampshire 105.5 miles Daniel Ressler None Daniel.R.Ressler@hitchcock.org
DartmouthHitchcock Medical Center - Lebanon, New Hampshire 105.5 miles Daniel Ressler None Daniel.R.Ressler@hitchcock.org
DartmouthHitchcock Medical Center - Lebanon, New Hampshire 105.5 miles Daniel Ressler None Daniel.R.Ressler@hitchcock.org
University of Maryland R Adams Cowley Shock Trauma Center - Baltimore, Maryland 358.9 miles Yasmin Degani None ydegani@umoa.umm.edu
University of Maryland R Adams Cowley Shock Trauma Center - Baltimore, Maryland 358.9 miles Yasmin Degani None ydegani@umoa.umm.edu
University of Maryland R Adams Cowley Shock Trauma Center - Baltimore, Maryland 358.9 miles Yasmin Degani None ydegani@umoa.umm.edu
University of Maryland R Adams Cowley Shock Trauma Center - Baltimore, Maryland 358.9 miles Yasmin Degani None ydegani@umoa.umm.edu
University of Maryland R Adams Cowley Shock Trauma Center - Baltimore, Maryland 358.9 miles Yasmin Degani None ydegani@umoa.umm.edu
MetroHealth Medical Center - Cleveland, Ohio 549.6 miles Mary Breslin None mbreslin@metrohealth.org
MetroHealth Medical Center - Cleveland, Ohio 549.6 miles Mary Breslin None mbreslin@metrohealth.org
MetroHealth Medical Center - Cleveland, Ohio 549.6 miles Mary Breslin None mbreslin@metrohealth.org
MetroHealth Medical Center - Cleveland, Ohio 549.6 miles Mary Breslin None mbreslin@metrohealth.org
MetroHealth Medical Center - Cleveland, Ohio 549.6 miles Mary Breslin None mbreslin@metrohealth.org
MetroHealth Medical Center - Cleveland, Ohio 549.6 miles Mary Breslin None mbreslin@metrohealth.org
Wake Forest University Baptist Medical Center - Winston-Salem, North Carolina 659.2 miles Martha Holden None mholden@wakehealth.edu
Wake Forest University Baptist Medical Center - Winston-Salem, North Carolina 659.2 miles Martha Holden None mholden@wakehealth.edu
Wake Forest University Baptist Medical Center - Winston-Salem, North Carolina 659.2 miles Martha Holden None mholden@wakehealth.edu
Wake Forest University Baptist Medical Center - Winston-Salem, North Carolina 659.2 miles Martha Holden None mholden@wakehealth.edu
Wake Forest University Baptist Medical Center - Winston-Salem, North Carolina 659.2 miles Martha Holden None mholden@wakehealth.edu
Wake Forest University Baptist Medical Center - Winston-Salem, North Carolina 659.2 miles Martha Holden None mholden@wakehealth.edu
Carolinas Medical Center - Charlotte, North Carolina 720.9 miles Rachel Seymour PhD None Rachel.Seymour@carolinashealthcare.org
Carolinas Medical Center - Charlotte, North Carolina 720.9 miles Rachel Seymour PhD None Rachel.Seymour@carolinashealthcare.org
Carolinas Medical Center - Charlotte, North Carolina 720.9 miles Rachel Seymour PhD None Rachel.Seymour@carolinashealthcare.org
Carolinas Medical Center - Charlotte, North Carolina 720.9 miles Rachel Seymour PhD None Rachel.Seymour@carolinashealthcare.org
Carolinas Medical Center - Charlotte, North Carolina 720.9 miles Rachel Seymour PhD None Rachel.Seymour@carolinashealthcare.org
Carolinas Medical Center - Charlotte, North Carolina 720.9 miles Rachel Seymour PhD None Rachel.Seymour@carolinashealthcare.org
Methodist Hospital - Indianapolis, Indiana 805.0 miles Lakye Deeter None lakedwar@iu.edu
Methodist Hospital - Indianapolis, Indiana 805.0 miles Lakye Deeter None lakedwar@iu.edu
Methodist Hospital - Indianapolis, Indiana 805.0 miles Lakye Deeter None lakedwar@iu.edu
Methodist Hospital - Indianapolis, Indiana 805.0 miles Lakye Deeter None lakedwar@iu.edu
Vanderbilt Medical Center - Nashville, Tennessee 944.2 miles Karen Trochez None karen.m.trochez@Vanderbilt.Edu
Vanderbilt Medical Center - Nashville, Tennessee 944.2 miles Karen Trochez None karen.m.trochez@Vanderbilt.Edu
Vanderbilt Medical Center - Nashville, Tennessee 944.2 miles Karen Trochez None karen.m.trochez@Vanderbilt.Edu
Vanderbilt Medical Center - Nashville, Tennessee 944.2 miles Karen Trochez None karen.m.trochez@Vanderbilt.Edu
Vanderbilt Medical Center - Nashville, Tennessee 944.2 miles Karen Trochez None karen.m.trochez@Vanderbilt.Edu
University of Tennessee RegionOne Medical Center - Memphis, Tennessee 1,135.7 miles Lynda WaddleSmith None lwaddle@uthsc.edu
University of Tennessee RegionOne Medical Center - Memphis, Tennessee 1,135.7 miles Lynda WaddleSmith None lwaddle@uthsc.edu
University of Tennessee RegionOne Medical Center - Memphis, Tennessee 1,135.7 miles Lynda WaddleSmith None lwaddle@uthsc.edu
University of Tennessee RegionOne Medical Center - Memphis, Tennessee 1,135.7 miles Lynda WaddleSmith None lwaddle@uthsc.edu
University of Tennessee RegionOne Medical Center - Memphis, Tennessee 1,135.7 miles Lynda WaddleSmith None lwaddle@uthsc.edu
University of Tennessee RegionOne Medical Center - Memphis, Tennessee 1,135.7 miles Lynda WaddleSmith None lwaddle@uthsc.edu
University of Mississippi Medical Center - Jackson, Mississippi 1,254.0 miles Josie Hydrick None jhydrick@umc.edu
University of Mississippi Medical Center - Jackson, Mississippi 1,254.0 miles Josie Hydrick None jhydrick@umc.edu
University of Mississippi Medical Center - Jackson, Mississippi 1,254.0 miles Josie Hydrick None jhydrick@umc.edu
University of Mississippi Medical Center - Jackson, Mississippi 1,254.0 miles Josie Hydrick None jhydrick@umc.edu
University of Mississippi Medical Center - Jackson, Mississippi 1,254.0 miles Josie Hydrick None jhydrick@umc.edu
University of Mississippi Medical Center - Jackson, Mississippi 1,254.0 miles Josie Hydrick None jhydrick@umc.edu
University of Miami Ryder Trauma Center - Miami, Florida 1,259.8 miles Dinorah Rodriquez None dinorah@med.miami.edu
University of Miami Ryder Trauma Center - Miami, Florida 1,259.8 miles Dinorah Rodriquez None dinorah@med.miami.edu
University of Miami Ryder Trauma Center - Miami, Florida 1,259.8 miles Dinorah Rodriquez None dinorah@med.miami.edu
University of Miami Ryder Trauma Center - Miami, Florida 1,259.8 miles Dinorah Rodriquez None dinorah@med.miami.edu
University of Texas Health Science Center at Houston - Houston, Texas 1,609.9 miles Matthew Galpin None Matthew.Galpin@uth.tmc.edu
University of Texas Health Science Center at Houston - Houston, Texas 1,609.9 miles Matthew Galpin None Matthew.Galpin@uth.tmc.edu
University of Texas Health Science Center at Houston - Houston, Texas 1,609.9 miles Matthew Galpin None Matthew.Galpin@uth.tmc.edu
University of Texas Health Science Center at Houston - Houston, Texas 1,609.9 miles Matthew Galpin None Matthew.Galpin@uth.tmc.edu
University of Texas Health Science Center at Houston - Houston, Texas 1,609.9 miles Matthew Galpin None Matthew.Galpin@uth.tmc.edu
University of Texas Health Science Center at Houston - Houston, Texas 1,609.9 miles Matthew Galpin None Matthew.Galpin@uth.tmc.edu
San Antonio Military Medical Center - San Antonio, Texas 1,761.3 miles Stephanie DeLeon None stephanie.deleon.ctr@mail.mil
San Antonio Military Medical Center - San Antonio, Texas 1,761.3 miles Stephanie DeLeon None stephanie.deleon.ctr@mail.mil
San Antonio Military Medical Center - San Antonio, Texas 1,761.3 miles Stephanie DeLeon None stephanie.deleon.ctr@mail.mil
San Antonio Military Medical Center - San Antonio, Texas 1,761.3 miles Stephanie DeLeon None stephanie.deleon.ctr@mail.mil
San Antonio Military Medical Center - San Antonio, Texas 1,761.3 miles Stephanie DeLeon None stephanie.deleon.ctr@mail.mil
San Antonio Military Medical Center - San Antonio, Texas 1,761.3 miles Stephanie DeLeon None stephanie.deleon.ctr@mail.mil
University of Arizona - Tucson, Arizona 2,281.0 miles Andrea Seach None aseach@email.arizona.edu
University of Arizona - Tucson, Arizona 2,281.0 miles Andrea Seach None aseach@email.arizona.edu
University of Arizona - Tucson, Arizona 2,281.0 miles Andrea Seach None aseach@email.arizona.edu
Harborview Medical Center - Seattle, Washington 2,489.6 miles Julie Agel None bagel@uw.edu
Harborview Medical Center - Seattle, Washington 2,489.6 miles Julie Agel None bagel@uw.edu
Harborview Medical Center - Seattle, Washington 2,489.6 miles Julie Agel None bagel@uw.edu
Harborview Medical Center - Seattle, Washington 2,489.6 miles Julie Agel None bagel@uw.edu
Harborview Medical Center - Seattle, Washington 2,489.6 miles Julie Agel None bagel@uw.edu
Harborview Medical Center - Seattle, Washington 2,489.6 miles Julie Agel None bagel@uw.edu

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.