[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566982":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":36,"locations":25,"responsibleParty":45,"collaborators":25,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":25,"enrollmentInfo":58,"targetDuration":25,"studyType":61,"phases":62,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":73,"whyStopped":25,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":25},{"fullName":5,"class":6},"Ottawa Hospital Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care","ACTIVE_COMPARATOR","Participants will receive Enoxaparin dosed at the discretion of the most responsible physician (MRP). In cases of severe renal insufficiency (CrCl \\\u003C 30mL\u002Fmin\\^:), the LMWH may dose reduced or changed to Heparin at the discretion of the MRP.",[13],"Drug: Standard of Care Dosing",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention (Anti-Xa Guided)","EXPERIMENTAL","Participants will receive Enoxaparin 0.5 mg\u002Fkg twice daily (rounded up or down to the nearest 10 mg) the initial starting dose. Dose adjustments will be made based on trough levels drawn between the 3rd and 4th dose. The target anti-Xa level range is between 0.1 and 0.2 IU\u002FmL. If the patient is below the target range, then the next Enoxaparin dose will be increased by 10 mg per dose with a new trough anti-Xa level 24 hours after dose modification. If the patient is above the target range, then the next Enoxaparin dose will be decreased by 10 mg per dose with a new trough anti-Xa level 24 hours after dose modification. This dose will be maintained until hospital discharge.",[19],"Drug: Anti-Xa Guided Dosing of Low Molecular Weight Heparin",[21,26],{"type":22,"name":23,"description":17,"armGroupLabels":24,"otherNames":25},"DRUG","Anti-Xa Guided Dosing of Low Molecular Weight Heparin",[15],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard of Care Dosing","Participants will receive Enoxaparin dosed at the discretion of the most responsible physician (MRP). In cases of severe renal insufficiency (CrCl \\< 30mL\u002Fmin\\^:), the LMWH may dose reduced or changed to Heparin at the discretion of the MRP.",[9],[31,34],{"name":32,"affiliation":5,"role":33},"Alexandre Tran, MD, MSc, FRCSC","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":5,"role":33},"Marc Carrier, MD, MSc, FRCPC",[37,42],{"name":32,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","613-737-8899","17076","aletran@toh.ca",{"name":43,"role":38,"phone":39,"phoneExt":40,"email":44},"Rebecca Porteous, RN, BNSC, CCRP","rporteous@ohri.ca",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Alexandre Tran","Associate Scientist","100566982","phase-2-anti-xa-guided-dosing-of-low-molecular-weight-heparin-for-prevention-of-venous-thromboembolism-following-traumatic-injury-a-multicentre-pilot-randomized-trial-100566982",false,"NCT06662253","Anti-Xa Guided Dosing of Low Molecular Weight Heparin for Prevention of Venous Thromboembolism Following Traumatic Injury: a Multicentre Pilot Randomized Trial","PrOVE iT","Inclusion Criteria:\n\n* Patients 18 years of age or older admitted to a hospital ward or intensive care unit following a traumatic injury involving two or more body systems (head, chest, abdomen, pelvis, extremity) and meeting at least one of the following high-risk criteria previously identified in a recent systematic review (1): age ≥ 65, body mass index ≥ 30 kg\u002Fm2, injury severity score ≥ 16, pelvic injury with activity restrictions, lower extremity injury with activity restrictions, or surgery during the index hospitalization.\n\nTo be eligible, patients must be deemed appropriate for pharmacologic prophylaxis by the most responsible physician and randomized with the intention to receive prophylaxis within 48 hours of admission. Prior to randomization, there is no restriction on whether or not patients have previously received pharmacologic or mechanical prophylaxis.\n\nExclusion Criteria:\n\n1. Greater than 7 days since time of injury.\n2. Requirement for therapeutic anticoagulation or dual-antiplatelet therapy\n3. Unable or unwilling to receive pharmacologic prophylaxis within 48 hours of admission.\n4. History of allergic reaction or sensitivity to LMWH.\n5. Thrombocytopenia with platelets \\< 30.\n6. Expected discharge or transfer from hospital within 72 hours.","ALL","18 Years",{"count":59,"type":60},150,"ESTIMATED","INTERVENTIONAL",[63,64],"PHASE2","PHASE3","This multicentre pilot trial will assess the feasibility of a full-scale, randomized trial to determine whether bloodwork guided dosing of blood thinners reduces the risk of clotting in high-risk trauma patients. Patients will receive either standard of care dosing or dosing with adjustments based on bloodwork to achieve a minimum therapeutic threshold.",[67,68],"Venous Thromboembolism (VTE)","Trauma Related Injuries",[70,71,72],"trauma","venous thromboembolism","prophylaxis","NOT_YET_RECRUITING","2024-10-24",{"date":76,"type":77},"2024-10-28","ACTUAL",{"date":79,"type":60},"2025-01",{"date":81,"type":60},"2026-09",{"name":47,"class":6}]