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Report for Clinical Trial NCT01999179

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Pilot Study of Post-thrombotic Syndrome & Predictors of Recurrence in Cancer Patients With Catheter-related Thrombosis

The goal of the pilot study is to determine if a multicenter prospective cohort study of cancer patients with blood clots associated with catheters is feasible. Cancer patients with catheter-related thrombosis treated with one month of anticoagulation will be evaluated for for post-thrombotic syndrome. Laboratory biomarkers will be evaluated as predictors of recurrent thrombosis.

NCT01999179 Venous Thrombosis Neoplasms
MeSH:Thrombosis Venous Thrombosis Postthrombotic Syndrome Postphlebitic Syndrome Recurrence
HPO:Deep venous thrombosis Venous thrombosis

1 Interventions

Name: Heparin, Low-Molecular-Weight, or direct oral anticoagulants

Description: Cancer patients will be treated with enoxaparin 1 mg/kg subcutaneously every 12 hours for one month following catheter removal or alternate enoxaparin dose or interval based on anti-factor Xa testing obtained by the clinical team or either apixaban, rivaroxaban, dabigatran, edoxaban following a catheter related blood clot
Type: Drug
Group Labels: 1

low-molecular-weight heparin or direct oral anticoagulant


Primary Outcomes

Description: Recruitment of 56 patients in 1 year and 80% completion of post-thrombotic syndrome assessments by enrolled patients

Measure: Number of cancer patients enrolled with catheter-related thrombosis treated with 1 month of anticoagulation

Time: 1 year

Secondary Outcomes

Description: Obtaining 80% of samples from enrolled patients

Measure: Number of plasma samples obtained for biomarker analysis to predict recurrent venous thrombosis

Time: 1 year

Other Outcomes

Description: <20% will have incidence of post-thrombotic syndrome 6 months after catheter removal

Measure: Incidence of post-thrombotic syndrome in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation

Time: 6 months after catheter removal

Description: <20% will have incidence of post-thrombotic syndrome 6 months after catheter removal

Measure: Incidence of recurrent thrombosis in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation

Time: 6 months after catheter removal

Description: <20% will have incidence of post-thrombotic syndrome 6 months after catheter removal

Measure: Incidence of major and clinically relevant non-major bleeding in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation

Time: 6 months after catheter removal

Purpose: Health Services Research

Allocation: N/A

Single Group Assignment


There are 2 SNPs

SNPs


1 G20210A

- >18 years of age - Platelet count >50,000 - Creatinine clearance >30 ml/min - Ability to provide informed consent Exclusion Criteria: - Underlying medical condition or chemotherapy requiring long-term anticoagulation - Known underlying higher risk thrombophilias including antiphospholipid antibody syndrome, antithrombin, protein C or protein S deficiencies, or homozygosity or compound heterozygosity for prothrombin G20210A or Factor V R506Q mutations. --- G20210A ---


2 R506Q

- >18 years of age - Platelet count >50,000 - Creatinine clearance >30 ml/min - Ability to provide informed consent Exclusion Criteria: - Underlying medical condition or chemotherapy requiring long-term anticoagulation - Known underlying higher risk thrombophilias including antiphospholipid antibody syndrome, antithrombin, protein C or protein S deficiencies, or homozygosity or compound heterozygosity for prothrombin G20210A or Factor V R506Q mutations. --- G20210A --- --- R506Q ---



HPO Nodes


HPO: