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

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Venous Thrombosis
• Intervention / Treatment: Drug: Heparin, Low-Molecular-Weight, or direct oral anticoagulants

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: low-molecular-weight heparin or direct oral anticoagulant; 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.

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; Other Names: enoxaparin; apixaban; rivaroxaban; dabigatran; edoxaban

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTS Assessment Completion	Percentage of participants who completed post-thrombotic syndrome assessments	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker Sample Collection	Number of participants that completed sample collection for biomarker analysis to predict recurrent venous thrombosis	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Ohio State University; Versiti
• Investigators: Principal Investigator: Lisa M Baumann Kreuziger, MD, MS, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): April 2, 2019
• Study Completion (Actual): April 26, 2022

Study Registration Dates

• First Submitted: November 25, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimate): December 3, 2013

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: cancer; catheter related thrombosis; upper extremity deep venous thrombosis; central venous catheters; Catheters
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Embolism and Thrombosis; Peripheral Vascular Diseases; Venous Insufficiency; Phlebitis; Recurrence; Thrombosis; Venous Thrombosis; Postthrombotic Syndrome; Postphlebitic Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Rivaroxaban; Dabigatran; Heparin; Apixaban; Edoxaban; Enoxaparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Anticoagulants
• Other Study ID Numbers: PRO21429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No