[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100458852":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":47,"locations":54,"responsibleParty":103,"collaborators":60,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":60,"eligibilityCriteria":112,"healthyVolunteers":109,"sex":113,"minAge":114,"maxAge":60,"enrollmentInfo":115,"targetDuration":60,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":60,"overallStatus":71,"whyStopped":60,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Ottawa Hospital Research Institute","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Modified dose LMWH without platelet transfusion support","EXPERIMENTAL","Patients will be given modified dose LMWH as below based on the first platelet count of the day (daily in admitted patients or at least 2 times a week in outpatients), without empiric platelet transfusion:\n\nI. Platelet count 25-50,000\u002FµL: 50% dose LMWH\n\nII. Platelet count \\\u003C 25,000\u002FµL: hold anticoagulation",[13,14,15],"Biological: Enoxaparin","Biological: Dalteparin","Biological: Tinzaparin",{"label":17,"type":18,"description":19,"interventionNames":20},"Higher dose LMWH with platelet transfusion support","ACTIVE_COMPARATOR","Patients assigned to higher dose LMWH (see below) will be given transfusion for 14 days when the first platelet count of the day falls below 50,000\u002FuL (daily inpatient or at least 2 times a week in outpatients). Post-transfusion counts will not be routinely obtained unless clinically indicated\n\nI. Platelet count 25-50,000\u002FµL: platelet transfusion + 100% dose LMWH\n\nII. Platelet count \\\u003C 25,000\u002FµL: platelet transfusion + 50% dose LMWH\n\nAfter Day 14, patients will be transitioned to modified dose LMWH as the other arm without platelet transfusion.\n\nLMWH can include enoxaparin, dalteparin, or tinzaparin, with 100% as:\n\n* Enoxaparin - 1mg\u002Fkg subcutaneously twice daily\n* Dalteparin - 200 IU\u002Fkg subcutaneously daily for 1 month then 150 U\u002Fkg daily\n* Tinzaparin - 175 units\u002Fkg subcutaneously daily",[13,14,15],[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BIOLOGICAL","Enoxaparin","I. Platelet count 25-50,000\u002FµL: 0.5mg\u002Fkg subcutaneously twice daily\n\nII. Platelet count \\\u003C 25,000\u002FµL: hold anticoagulation",[17,9],[28],"Lovenox",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Dalteparin","I. Platelet count 25-50,000\u002FµL: 100 IU\u002Fkg subcutaneously daily for the first month of an acute VTE then 75 U\u002Fkg\n\nII. Platelet count \\\u003C 25,000\u002FµL: hold anticoagulation",[17,9],[34],"Fragmin",{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Tinzaparin","I. Platelet count 25-50,000\u002FµL: 87.5 units\u002Fkg subcutaneously daily\n\nII. Platelet count \\\u003C 25,000\u002FµL: hold anticoagulation",[17,9],[40],"Innohep",[42,45],{"name":43,"affiliation":5,"role":44},"Tzu-Fei Wang, MD","PRINCIPAL_INVESTIGATOR",{"name":46,"affiliation":5,"role":44},"Marc Carrier, MD",[48],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},"Jennifer Brinkhurst","CONTACT","+16137378899","71068","jbrinkhurst@ohri.ca",[55,69,85,91],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":60},"University of Alberta","WITHDRAWN","Edmonton","Alberta",null,"Canada","CA",{"type":64,"coordinates":65},"Point",[66,67],-113.46871,53.55014,{"lat":67,"lon":66},{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":61,"countryCode":62,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"The Ottawa Hospital","RECRUITING","Ottawa","Ontario","K1H 8L6",{"type":64,"coordinates":76},[77,78],-75.69812,45.41117,{"lat":78,"lon":77},[81,84],{"name":82,"role":50,"phone":83,"phoneExt":52,"email":53},"Jennifer Multicentre Trial Coordinator","6137378899",{"name":43,"role":44,"phone":60,"phoneExt":60,"email":60},{"facility":86,"status":71,"city":87,"state":73,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":60,"geoPoint":60,"contacts":88},"Niagara Health - St. Catharines Site","Saint Catharines",[89],{"name":90,"role":44,"phone":60,"phoneExt":60,"email":60},"Blair Leonard",{"facility":92,"status":71,"city":93,"state":73,"zip":94,"country":61,"countryCode":62,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Windsor Regional Hospital","Windsor","N8W 1L9",{"type":64,"coordinates":96},[97,98],-83.01654,42.30008,{"lat":98,"lon":97},[101],{"name":102,"role":50,"phone":60,"phoneExt":60,"email":60},"Andrea Cervi, MD",{"type":104,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":60,"oldOrganization":60},"SPONSOR_INVESTIGATOR","Tzu-Fei Wang","Qualified Investigator","100458852","phase-4-strategies-for-anticoagulation-in-patients-with-thrombocytopenia-and-cancer-associated-thrombosis-100458852",false,"NCT05255003","STrategies for Anticoagulation in Patients With thRombocytopenia and Cancer-associated Thrombosis","Inclusion Criteria:\n\n1. Adult patients (age ≥ 18) with active malignancy (malignancy diagnosed or treated within the previous 6 months, or progressive\u002Frelapsed);\n2. Objectively confirmed VTE within last 14 days for which therapeutic anticoagulation is planned;\n3. Thrombocytopenia with a platelet count \\\u003C 50,000\u002FuL from cancer therapy or malignancy itself;\n4. Able to provide written informed consent\n\nExclusion Criteria:\n\n1. Receipt of anticoagulant for index VTE with platelet count \\\u003C 50,000\u002FuL for \\> 72 hours;\n2. Superficial vein thrombosis only;\n3. Life expectancy \\\u003C 1 month (as judged by the treating physicians);\n4. Creatinine clearance \\\u003C 30 ml\u002Fmin;\n5. Contraindication to LMWH such as a history of heparin induced thrombocytopenia;\n6. Thrombocytopenia from other causes, such as thrombotic microangiopathy, immune thrombocytopenia, disseminated intravascular coagulation;\n7. Previously documented history of refractoriness to platelet transfusion secondary to HLA antibodies;\n8. Refusal of blood products;\n9. Anticoagulation at any dose is deemed unsafe (i.e. active bleeding or bleeding disorders)","ALL","18 Years",{"count":116,"type":117},50,"ESTIMATED","INTERVENTIONAL",[120],"PHASE4","Patients with cancer are prone to have blood clots, which are usually treated with blood thinners. The main complication of blood thinners is bleeding. This is especially a concern when the number of platelets in the blood is lower than 50,000 per microliter. The role of platelets is to stop bleeding, so when the number of platelets is low, patients are at a higher risk of bleeding. Cancer patients are prone to have lower platelet numbers due to cancer therapies and\u002For cancer itself. It is not clear what the best treatment is for cancer patients who need blood thinners for a blood clot but have low platelet counts.\n\nThe investigators plan to do a small study called a pilot study to help plan for a larger study in such patients. In the pilot study, investigators will include 50 patients with cancer, low platelet counts, and a blood clot diagnosed within 2 weeks. Patients will be randomly assigned to one of the two treatment strategies: the full dose of blood thinners along with platelet transfusion or a reduced dose of blood thinners without platelet transfusion. The investigators will follow all patients for 30 days. If this pilot study is successful, it will help lead to a much larger trial, which will provide important information on the best treatment strategy for these patients.",[123,124],"Cancer-associated Thrombosis","Thrombocytopenia","2025-12-09",{"date":127,"type":128},"2025-12-17","ACTUAL",{"date":130,"type":128},"2022-08-29",{"date":132,"type":117},"2027-01-31",{"name":105,"class":6},4]