N/A
N=27
Post-thrombotic Syndrome & Predictors of Recurrence in Catheter-related Thrombosis
Venous Thrombosis · Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01999179 ↗Enrolled (actual)
27
Serious AEs
3.7%
Results posted
Dec 2021
Primary outcome: Primary: PTS Assessment Completion — 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Heparin, Low-Molecular-Weight, or direct oral anticoagulants (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PTS Assessment Completion |
17 | — |
| SECONDARY Biomarker Sample Collection |
7 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01999179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.