Neoplasms, Venous Thrombosis
Conditions
Keywords
catheter related thrombosis, upper extremity deep venous thrombosis, central venous catheters, cancer, Catheters
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.
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.
Interventions
DRUGHeparin, 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
Sponsors
Versiti Blood Health
Ohio State University
Medical College of Wisconsin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTS Assessment Completion | 1 year | Percentage of participants who completed post-thrombotic syndrome assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarker Sample Collection | 1 year | Number of participants that completed sample collection for biomarker analysis to predict recurrent venous thrombosis |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Change in Therapy | 3 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | New catheter | 2 |
Baseline characteristics
| Characteristic | Low-molecular-weight Heparin or Direct Oral Anticoagulant |
|---|---|
| Age, Continuous | 59 years |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 27 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 2 / 27 |
| serious Total, serious adverse events | 1 / 27 |
Outcome results
Primary
PTS Assessment Completion
Percentage of participants who completed post-thrombotic syndrome assessments
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-molecular-weight Heparin or Direct Oral Anticoagulant | PTS Assessment Completion | 17 Participants |
Secondary
Biomarker Sample Collection
Number of participants that completed sample collection for biomarker analysis to predict recurrent venous thrombosis
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low-molecular-weight Heparin or Direct Oral Anticoagulant | Biomarker Sample Collection | 7 participants |
Other Pre-specified
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
Time frame: 6 months after catheter removal
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-molecular-weight Heparin or Direct Oral Anticoagulant | Number of Participants With Major Bleeding | 1 Participants |
Other Pre-specified
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
Time frame: 6 months after catheter removal
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-molecular-weight Heparin or Direct Oral Anticoagulant | Number of Participants With Post-thrombotic Syndrome | 0 Participants |
Other Pre-specified
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
Time frame: 6 months after catheter removal
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-molecular-weight Heparin or Direct Oral Anticoagulant | Number of Participants With Recurrent Thrombosis | 0 Participants |