Clinical trial NCT01999179: Post-thrombotic Syndrome & Predictors of Recurrence in Catheter-related Thrombosis
Official title: Pilot Study of Post-thrombotic Syndrome & Predictors of Recurrence in Cancer Patients With Catheter-related Thrombosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thrombosis
Neoplasms
Keywords: catheter related thrombosis
upper extremity deep venous thrombosis
central venous catheters
cancer
Catheters
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Versiti
name: Ohio State University
First posted: 2013-12-03
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: Participants may be referred for screening at Medical College of Wisconsin (MCW) in two possible mechanisms: participant contact study staff from information on Clinical Trials Science Institute (CTSI) FACT website or referral from treating Hematologist or Oncologist. At MCW, an EPIC report will be generated to identify people with catheter related thrombosis (CRT). The treating provider would then be contacted to determine if referral to the study was appropriate. Subjects at Ohio State University (OSU) will be referred from the treating Hematologist or Oncologist. A report generated in Epic will be used to identify people with CRT. The treating provider would then be contacted to determine if referral to the study was appropriate. Participants will be given printed information about the study or verbal explanation using the informational flyer. Verbal consent will be obtained to be screened for participation and contacted by study personnel. Screening will be completed by BloodCenter of Wisconsin (BCW) nurse coordinator. We aim to consent and enroll patients after diagnosis of catheter-related thrombosis and prior to catheter removal. Consent and enrollment (Visit 1) must occur prior to discontinuation of anticoagulation. Participants will be treated with either enoxaparin for one month following catheter removal, or direct oral anticoagulant treatment (apixaban, rivaroxaban, dabigatran, or edoxaban). Anticoagulation will be continued for 1 month after catheter removal. The minimum duration of anticoagulation will be one month and maximum duration is 7 months. The cost of enoxaparin will be the responsibility of the participant as use of the medication is part of routine care. Subjects will be contacted by telephone prior to discontinuation of anticoagulation to review study protocol, assess for bleeding, and see if any continuation rules apply and arrange for research visit 2 in the following 1-2 weeks. Visits 3 and 4 will occur 3 and 6 months after catheter removal, respectively. At visits 3 \& 4, Medical history, cancer history, and medications will be updated. At each visit, participants will be assessed for post-thrombotic syndrome using the modified Villalta scale and functional limitation using the DASH questionnaire. At MCW, surveys will be administered by the research coordinator and/or Translational Research Unit (TRU) staff and physical examination will be completed by BCW nurse coordinator. At OSU, surveys will be administered by research coordinators and physical examination will be administered by research nurse coordinator. Laboratory samples will be obtained for MCW participants only.

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

Primary outcomes:
measure: PTS Assessment Completion
timeFrame: 1 year
Secondary outcomes:
measure: Biomarker Sample Collection
timeFrame: 1 year
Other outcomes:
measure: Number of Participants With Post-thrombotic Syndrome
timeFrame: 6 months after catheter removal
measure: Number of Participants With Recurrent Thrombosis
timeFrame: 6 months after catheter removal
measure: Number of Participants With Major Bleeding
timeFrame: 6 months after catheter removal
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Lisa M Baumann Kreuziger, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: