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

NCT01999179 | Completed Results DMC

• 1 other identifier: PRO21429
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

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.

Conditions

Venous Thrombosis; Neoplasms

Keywords

catheter related thrombosis; upper extremity deep venous thrombosis; central venous catheters; cancer; Catheters

Outcome Measures

Primary Outcomes (1)

• PTS Assessment Completion

  Percentage of participants who completed post-thrombotic syndrome assessments

  1 year

Secondary Outcomes (1)

• Biomarker Sample Collection

  1 year

Other Outcomes (3)

• Number of Participants With Post-thrombotic Syndrome

  6 months after catheter removal

• Number of Participants With Recurrent Thrombosis

  6 months after catheter removal

• Number of Participants With Major Bleeding

  6 months after catheter removal

Study Arms (1)

low-molecular-weight heparin or direct oral anticoagulant

OTHER

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

Interventions

Heparin, Low-Molecular-Weight, or direct oral anticoagulants DRUG

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

Also known as: enoxaparin, apixaban, rivaroxaban, dabigatran, edoxaban

low-molecular-weight heparin or direct oral anticoagulant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Versiti Blood Health: collaborator
• Ohio State University: collaborator

Study Sites (3)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Venous Thrombosis; Neoplasms

Interventions

Heparin; Enoxaparin; apixaban; Rivaroxaban; Dabigatran; edoxaban

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Heparin, Low-Molecular-Weight; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr Lisa Baumann Kreuziger
• Organization: Versiti

lisakreuziger@versiti.org

414-937-6826

Study Officials

• Lisa M Baumann Kreuziger, MD, MS

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 3, 2013
• Study Start: June 1, 2014
• Primary Completion: April 2, 2019
• Study Completion: April 26, 2022
• Last Updated: May 18, 2022
• Results First Posted: December 22, 2021

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)