A Study to Collect Information about Biomarkers (Lab Test Results) that May Help to Predict Which People with Calf Vein Clots May be at Higher or Lower Risk of Having the Clot Grow or Progress
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-000886
Sponsor Protocol Number: 18-000886
About this study
This is a biomarker correlate study for a study which is randomizing patients with calf deep venous thrombosis (calf vein clots) to treatment with blood thinners or not to see if the blood thinner is necessary.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria (same as those in the main Calf DVT study):
- Age range: 18 years and older.
- Both males and females.
- Confirmed acute calf vein thrombosis confined to either the deep (posterior tibial, anterior tibial, or peroneal) or muscular (gastrocnemius or soleal) veins.
- Ability to provide written informed consent.
- Confirmed acute calf vein thrombosis confined to either the deep (posterior tibial, anterior tibial, or peroneal) or muscular (gastrocnemius or soleal) veins.
- Ability to provide written informed consent.
Exclusion Criteria (same as those from the main Calf DVT study):
- Age < 18 years.
- More than 48 hours pre-randomization treatment with therapeutic dosages of anticoagulant.
- Creatinine clearance < 25 ml/min. (within last two weeks)
- Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALT > 3 x ULN. (within last two weeks)
- Platelet count < 50 x109/L.(within last two weeks)
- Life expectancy < 12 months.
- Active bleeding.
- Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketoconazole) or strong CYP 3A4 inducers like rifampicin.
- Active cancer.
- Anticipated need for surgery/major invasive procedure within the next 3 months.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Ariela Marshall, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available