1704113280 1704113280 1704113280 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

RN

Roman Natoli, MD

Principal Investigator

Status: Enrolling By Invitation Ages: 100 Years Gender: All Genders Phase: N/A 2 Locations

Brief Description

The purpose of this research study is to help determine the best treatment for preventing blood clots that are formed following trauma that could potentially lead to death. At the moment researchers do not know if using medications called low molecular weight heparin or aspirin is better in preventing life threatening blot clots in trauma patients. In this study, we are trying to answer this question. Usually either low molecular weight heparin is given by subcutaneous (under the skin) injections (liquid) medicine or aspirin (pill) medicine is given by mouth while in the hospital and after hospital discharge to prevent blood clots. There has not been a study to compare these two types of medicines for preventing blood clots in trauma patients and order to find out which medicine is best this study will compare these two forms of treatment.

Detailed Description

The proposed study is a pragmatic multi-center, prospective, randomized trial of 30 mg of subcutaneous low molecular weight heparin/enoxaparin (LMWH) administered twice daily versus 81 mg of enteral aspirin (ASA) taken twice daily in orthopaedic trauma patients. Treatment will be initiated during the initial hospitalization for injury, and will continue for the duration of time the patient is prescribed prophylactic clot prevention medication, per the standard of care at the treating facility. Patients will be followed for 3 months following date of randomization to the trauma center to assess for death, rehospitalization, or complication which occurred between discharge and follow up. At this time, satisfaction, adherence and out of pocket costs will also be reported.

Eligibility of study

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

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Visit allinforhealth.info to see if you're eligible and join the study.