Thrombocytopenia Clinical Trial
Official title:
STrategies for Anticoagulation in Patients With thRombocytopenia and Cancer-associated Thrombosis
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/or 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. The 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 4 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 90 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 in these patients.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | March 31, 2025 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adult patients (age = 18) with active malignancy (malignancy diagnosed or treated within the previous 6 months, or progressive/relapsed); 2. Objectively confirmed VTE within last 14 days for which therapeutic anticoagulation is planned; 3. Thrombocytopenia with a platelet count < 50,000/uL from cancer therapy or malignancy itself; 4. Able to provide written informed consent Exclusion Criteria: 1. Receipt of anticoagulant for index VTE with platelet count < 50,000/uL for > 72 hours; 2. Superficial vein thrombosis only; 3. Life expectancy < 1 month (as judged by the treating physicians); 4. Creatinine clearance < 30 ml/min; 5. Contraindication to LMWH such as a history of heparin induced thrombocytopenia; 6. Thrombocytopenia from other causes, such as thrombotic microangiopathy, immune thrombocytopenia, disseminated intravascular coagulation; 7. Previously documented history of refractoriness to platelet transfusion secondary to HLA antibodies; 8. Refusal of blood products; 9. Anticoagulation at any dose is deemed unsafe (i.e. active bleeding or bleeding disorders) |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
Canada | The Ottawa Hospital | Ottawa | Ontario |
Canada | Windsor Regional Hospital | Windsor | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility - The average number of patients recruited per month | The average number of patients recruited per month | 18 months | |
Secondary | Feasibility - Proportion of eligible patients who provide consent | Number of consenting participants from the number of eligible patients | 18 months | |
Secondary | Feasibility - Reasons for non-participation in eligible patients | Reasons for non-participation in eligible patients | 18 months | |
Secondary | Feasibility - Number of patients who complete study procedures by adhering to protocol | Number of participants adhering to the protocol (such as anticoagulation, transfusion, platelet count monitoring according to the protocol) | 18 months | |
Secondary | Feasibility - Rates of withdrawal | Number of participants withdrawing from study | 18 months | |
Secondary | Feasibility - Loss to follow-up | Number of participants lost to follow-up | 18 months | |
Secondary | Feasibility - Crossover between treatment arms | Number of participants crossing over between treatment arms | 18 months | |
Secondary | Clinical Outcome - Rate of clinically relevant bleeding (composite of major bleeding and clinically relevant non-major bleeding events) | Rate of clinically relevant bleeding (composite of major bleeding and clinically relevant non-major bleeding events) | 18 months | |
Secondary | Clinical Outcome - Rate of symptomatic or incidentally detected recurrent or new major VTE | Rate of symptomatic or incidentally detected recurrent or new major VTE | 18 months | |
Secondary | Clinical Outcome - PE-related death | PE-related death | 18 months | |
Secondary | Clinical Outcome - Composite of recurrent VTE and major bleeding events | Composite of recurrent VTE and major bleeding events | 18 months | |
Secondary | Clinical Outcome - Non-major VTE (distal upper or lower extremity DVT, superficial upper or lower extremity vein thrombosis) | Number of non-major VTE (distal upper or lower extremity DVT, superficial upper or lower extremity vein thrombosis) | 18 months | |
Secondary | Clinical Outcome - Duration of thrombocytopenia (days of platelet count < 50,000/uL) per patient | Duration of thrombocytopenia (days of platelet count < 50,000/uL) per patient | 18 months | |
Secondary | Clinical Outcome - Number of transfused units and adverse platelet transfusion reactions | Number of transfused units and adverse platelet transfusion reactions | 18 months | |
Secondary | Clinical Outcome - Overall mortality | Overall mortality | 18 months | |
Secondary | Clinical Outcome - Health-related quality of life using EuroQoL-EQ-5D-5L questionnaire | Health-related quality of life using EuroQoL-EQ-5D-5L questionnaire | 18 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04003220 -
Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker
|
||
Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Recruiting |
NCT03633019 -
High-dose Use of rhTPO in CIT Patients
|
Phase 4 | |
Recruiting |
NCT06087198 -
Clinical Performance Evaluation of T-TAS®01 HD Chip
|
||
Recruiting |
NCT03605511 -
TTP and aHUS in Complicated Pregnancies
|
||
Active, not recruiting |
NCT03688191 -
Study of Sirolimus in CTD-TP in China
|
Phase 4 | |
Completed |
NCT02845609 -
Efficacy of Sialic Acid GNE Related Thrombocytopenia
|
Phase 2 | |
Recruiting |
NCT02241031 -
Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia
|
Phase 2/Phase 3 | |
Recruiting |
NCT02244658 -
Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia
|
Phase 3 | |
Unknown status |
NCT01196884 -
Immune Thrombocytopenia (ITP) Immune-Genetic Assessment
|
||
Terminated |
NCT01368211 -
Mirasol-Treated Platelets - (Pathogen Reduction Extended Storage Study)
|
Phase 2/Phase 3 | |
Completed |
NCT01356576 -
Effect of Hemodialysis Membranes on Platelet Count
|
N/A | |
Completed |
NCT00039858 -
Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin
|
Phase 4 | |
Completed |
NCT00787241 -
Platelet Count Trends in Pre-eclamptic Parturients
|
N/A | |
Completed |
NCT00001533 -
Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders With Cyclosporine
|
Phase 1 | |
Not yet recruiting |
NCT06036966 -
The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer Patients
|
Phase 2 | |
Completed |
NCT01791101 -
Eltrombopag in Patients With Delayed Post Transplant Thrombocytopenia.
|
Phase 2 | |
Recruiting |
NCT06053021 -
Antiplatelet Therapy for AIS Patients With Thrombocytopenia
|
N/A | |
Recruiting |
NCT03701217 -
Eltrombopag Used in Thrombocytopenia After Comsolidation Therapy in AML
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT05958511 -
Assessment of Risk Factors and Outcome of Thrombocytopenia in ICU Patients
|