Clinical trial · Interventional
Post-thrombotic Syndrome & Predictors of Recurrence in Catheter-related Thrombosis
Pilot Study of Post-thrombotic Syndrome & Predictors of Recurrence in Cancer Patients With Catheter-related Thrombosis
NCT01999179CI-TRIAL-00058571completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Venous Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Heparin, Low-Molecular-Weight, or direct oral anticoagulants | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- low-molecular-weight heparin or direct oral anticoagulant
- description
- 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 that was obtained by clinical team. Apixaban, rivaroxaban, dabigatran, or edoxaban at standard dosing per FDA package insert for direct oral anticoagulants.
- interventionNames
- Drug: Heparin, Low-Molecular-Weight, or direct oral anticoagulants
Primary outcomes (1)
- measure
- PTS Assessment Completion
- timeFrame
- 1 year
- description
- Percentage of participants who completed post-thrombotic syndrome assessments
Secondary outcomes (1)
- measure
- Biomarker Sample Collection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Upper extremity venous thrombosis associated with an indwelling catheter documented by ultrasound, CT or venography * Current hematologic or solid tumor malignancy undergoing chemotherapy, surgery, radiation or hormonal therapy for malignancy. * \>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. * Inability to remove venous catheter * Anticipated replacement of central venous catheter within 3 months * Major bleeding or clinically relevant non-major bleeding in the preceding 60 days * Participation in another clinical trial that requires anticoagulation * Use of anticoagulant other than low-molecular weight heparin * Treatment with thrombolysis * Catheter removal \>1 month prior to enrollment
References
Publications (0)
Data not yet available
No reference posted for this study.