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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01999179
• Other study ID #: PRO21429
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: April 26, 2022

Study information

• Verified date: April 2022
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 26, 2022
• Est. primary completion date: April 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Recurrence
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Heparin, Low-Molecular-Weight, or direct oral anticoagulants
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

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Ohio State University, Versiti

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Post-thrombotic Syndrome	The number of participants with post-thrombotic syndrome 6 months after catheter removal in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation	6 months after catheter removal
Other	Number of Participants With Recurrent Thrombosis	Number of participants with recurrent thrombosis in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation	6 months after catheter removal
Other	Number of Participants With Major Bleeding	Number of participants with major bleeding in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation	6 months after catheter removal
Primary	PTS Assessment Completion	Percentage of participants who completed post-thrombotic syndrome assessments	1 year
Secondary	Biomarker Sample Collection	Number of participants that completed sample collection for biomarker analysis to predict recurrent venous thrombosis	1 year