Post-thrombotic Syndrome & Predictors of Recurrence in Catheter-related Thrombosis

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.

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