AzTrials
AzTrials

Blood ClotPhase 3PREVENT CLOTNCT02984384

PREVENTion of Clot in Orthopaedic Trauma

A Phase 3 study testing Acetylsalicylic acid and Low Molecular Weight Heparin (LMWH) in people with Blood Clot and Trauma, run by Major Extremity Trauma Research Consortium at 21 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Blood Clot, Trauma
What is being tested?
Acetylsalicylic acid and Low Molecular Weight Heparin (LMWH)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12,424 participants
Where
21 sitesin 2 countries
Study dates
24 Apr 2017to 18 Feb 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

United States19 sites

  • University of Maryland R Adams Cowley Shock Trauma Center

    Baltimore, Maryland, 21201

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Carolinas Medical Center

    Charlotte, North Carolina, 28204

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Methodist Hospital

    Indianapolis, Indiana, 46202

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • University of Tennessee, RegionOne Medical Center

    Memphis, Tennessee, 38103

  • University of Miami Ryder Trauma Center

    Miami, Florida, 33136

  • Vanderbilt Medical Center

    Nashville, Tennessee, 37232

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Rhode Island Hospital, Brown University

    Providence, Rhode Island, 02903

  • San Antonio Military Medical Center

    San Antonio, Texas, 78219

  • Harborview Medical Center

    Seattle, Washington, 98104

  • University of Arizona

    Tucson, Arizona, 85724

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada2 sites

  • University of Calgary, Foothills Medical Centre

    Calgary, Alberta

  • McMaster University, Hamilton General Hospital

    Hamilton, Ontario

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Blood Clot, Trauma
Being tested
Acetylsalicylic acid, Low Molecular Weight Heparin (LMWH)
Keywords
Trauma, Blood clot, Venous Thromboembolism, Pulmonary Embolism, Deep Vein Thrombosis, Thromboprophylaxis, Blood clot prevention, trauma patients
Medical subject headings
Thrombosis, Wounds and Injuries, Venous Thromboembolism, Pulmonary Embolism, Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acetylsalicylic acidDrug

    Also called Aspirin

    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)Drug

    Also called Enoxaparin

    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.

Study groups in NCT02984384
Study groupRoleWhat they receive
Low Molecular Weight Heparin (LMWH)-EnoxaparinActive comparatorInjection of 30 mg enoxaparin, twice a day via injection
Receives: Drug: Low Molecular Weight Heparin (LMWH)
Acetylsalicylic acid (ASA)-AspirinActive comparatorEnteral ingestion or administration of 81 mg ASA, twice a day
Receives: Drug: Acetylsalicylic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With All-cause Mortality

    Death from any cause

    Measured: 90 days

Secondary outcomes (6)

  1. Number of Participants With Cause-specific Death

    Cause specific death. Some participants are reported twice if reason for death met more than one category.

    Measured: 90 days

  2. Non-fatal Pulmonary Embolism

    Measured: 90 days

  3. Deep Vein Thrombosis

    Measured: 90 days

  4. Bleeding Complication

    Measured: 90 days

  5. Wound Complication

    Measured: 90 days

  6. Deep Surgical Site Infection

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2016 (estimated)
  2. Study start24 Apr 2017
  3. Primary completion18 Feb 2022
  4. Study completion18 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
12,424 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02984384
Sponsor's protocol ID
PCS-1511-32745
Acronym
PREVENT CLOT
Status last verified
Apr 2024
First submitted
2 Dec 2016
Last updated
14 May 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 33762229

  • Major Extremity Trauma Research Consortium (METRC); O'Toole RV, Stein DM, O'Hara NN, Frey KP, Taylor TJ, Scharfstein DO, Carlini AR, Sudini K, Degani Y, Slobogean GP, Haut ER, Obremskey W, Firoozabadi R, Bosse MJ, Goldhaber SZ, Marvel D, Castillo RC. Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis after a Fracture. N Engl J Med. 2023 Jan 19;388(3):203-213. doi: 10.1056/NEJMoa2205973.

    PubMed 36652352

  • 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.

    PubMed 31604788

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Acetylsalicylic acid and Low Molecular Weight Heparin (LMWH) in people with Blood Clot and Trauma, run by Major Extremity Trauma Research Consortium at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With All-cause Mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02984384, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in