Evaluation of Thrombin Generation in Children with Venous Thromboembolism

Study ID
STU 102013-036

Cancer Related

Healthy Volunteers

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Kendra Malone

Principal Investigator
Ayesha Zia, M.D.


This pilot study will collect 1.8 to 10 mls (depending on the age/weight of the child) of blood for thrombin generation testing from 50 subjects diagnosed wiht a first venous embolism prior to or just after completion of anticoagulation treatment. This blood will be collected at the same time as the standard of care labs.

The control group will be comprised of healthy volunteers who are scheduled to have minor surgery at Children's Health. The blood sample for the study will be collected in the surgery clinic at a regularly scheduled visit (if the patient is having blood collected already) or at the same time as the iV is started for the surgery.

The secondary aim of this study is to evaluate the ability of two new non-criteria aPLs assays (aPhL and aPT/PS) to serve as biomarkers to identify pediatric patients with high risk for recurrent thromboembolic events.

Participant Eligibility

1. Children birth to less than/equal to 18 years with a radiologically proven VTE at the time of diagnosis;
2. Children birth to less than/equal years with a radiologically proven VTE at the time of completion of therapeutic anticoagulation with at least a 1-2 week wash out period (1 week for parenteral an 2 weeks for oral anticoagulants;
3. Medically stable subjects;
4. Normal, healthy volunteers (for the control group)