Post-thrombotic Syndrome & Predictors of Recurrence in Catheter-related Thrombosis
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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 Design
Arms and Interventions
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:
|
Outcome Measures
Primary Outcome Measures
- PTS Assessment Completion [1 year]
Percentage of participants who completed post-thrombotic syndrome assessments
Secondary Outcome Measures
- Biomarker Sample Collection [1 year]
Number of participants that completed sample collection for biomarker analysis to predict recurrent venous thrombosis
Other Outcome Measures
- Number of Participants With Post-thrombotic Syndrome [6 months after catheter removal]
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
- Number of Participants With Recurrent Thrombosis [6 months after catheter removal]
Number of participants with recurrent thrombosis in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation
- Number of Participants With Major Bleeding [6 months after catheter removal]
Number of participants with major bleeding in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
2 | The Ohio State University | Columbus | Ohio | United States | 43210 |
3 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- Medical College of Wisconsin
- Versiti
- Ohio State University
Investigators
- Principal Investigator: Lisa M Baumann Kreuziger, MD, MS, Medical College of Wisconsin
Study Documents (Full-Text)
More Information
Publications
None provided.- PRO21429
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Low-molecular-weight Heparin or Direct Oral Anticoagulant |
---|---|
Arm/Group Description | 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. 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 |
Period Title: Overall Study | |
STARTED | 27 |
COMPLETED | 20 |
NOT COMPLETED | 7 |
Baseline Characteristics
Arm/Group Title | Low-molecular-weight Heparin or Direct Oral Anticoagulant |
---|---|
Arm/Group Description | 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. 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 |
Overall Participants | 27 |
Age (years) [Median (Inter-Quartile Range) ] | |
Median (Inter-Quartile Range) [years] |
59
|
Sex: Female, Male (Count of Participants) | |
Female |
11
40.7%
|
Male |
16
59.3%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
1
3.7%
|
Asian |
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
5
18.5%
|
White |
21
77.8%
|
More than one race |
0
0%
|
Unknown or Not Reported |
0
0%
|
Region of Enrollment (Count of Participants) | |
United States |
27
100%
|
Outcome Measures
Title | PTS Assessment Completion |
---|---|
Description | Percentage of participants who completed post-thrombotic syndrome assessments |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Low-molecular-weight Heparin or Direct Oral Anticoagulant |
---|---|
Arm/Group Description | 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. 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 |
Measure Participants | 27 |
Count of Participants [Participants] |
17
63%
|
Title | Biomarker Sample Collection |
---|---|
Description | Number of participants that completed sample collection for biomarker analysis to predict recurrent venous thrombosis |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Low-molecular-weight Heparin or Direct Oral Anticoagulant |
---|---|
Arm/Group Description | 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. 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 |
Measure Participants | 12 |
Number [participants] |
7
25.9%
|
Title | Number of Participants With Post-thrombotic Syndrome |
---|---|
Description | 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 |
Time Frame | 6 months after catheter removal |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Low-molecular-weight Heparin or Direct Oral Anticoagulant |
---|---|
Arm/Group Description | 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. 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 |
Measure Participants | 20 |
Count of Participants [Participants] |
0
0%
|
Title | Number of Participants With Recurrent Thrombosis |
---|---|
Description | Number of participants with recurrent thrombosis in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation |
Time Frame | 6 months after catheter removal |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Low-molecular-weight Heparin or Direct Oral Anticoagulant |
---|---|
Arm/Group Description | 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. 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 |
Measure Participants | 20 |
Count of Participants [Participants] |
0
0%
|
Title | Number of Participants With Major Bleeding |
---|---|
Description | Number of participants with major bleeding in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation |
Time Frame | 6 months after catheter removal |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Low-molecular-weight Heparin or Direct Oral Anticoagulant |
---|---|
Arm/Group Description | 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. 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 |
Measure Participants | 20 |
Count of Participants [Participants] |
1
3.7%
|
Adverse Events
Time Frame | 6 months | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Low-molecular-weight Heparin or Direct Oral Anticoagulant | |
Arm/Group Description | 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. 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 | |
All Cause Mortality |
||
Low-molecular-weight Heparin or Direct Oral Anticoagulant | ||
Affected / at Risk (%) | # Events | |
Total | 0/27 (0%) | |
Serious Adverse Events |
||
Low-molecular-weight Heparin or Direct Oral Anticoagulant | ||
Affected / at Risk (%) | # Events | |
Total | 1/27 (3.7%) | |
Musculoskeletal and connective tissue disorders | ||
Hematoma | 1/27 (3.7%) | |
Other (Not Including Serious) Adverse Events |
||
Low-molecular-weight Heparin or Direct Oral Anticoagulant | ||
Affected / at Risk (%) | # Events | |
Total | 2/27 (7.4%) | |
Blood and lymphatic system disorders | ||
Bleeding | 2/27 (7.4%) | |
General disorders | ||
Fall | 2/27 (7.4%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr Lisa Baumann Kreuziger |
---|---|
Organization | Versiti |
Phone | 414-937-6826 |
lisakreuziger@versiti.org |
- PRO21429