Pro00037528; Prospective Multi-Center Evaluation of the Duration of Therapy for Thrombosis in Children (the ?Kids-DOTT? Trial) Save

Date Added
December 23rd, 2014
PRO Number
Pro00037528
Researcher
Stuart Cramer
Keywords
Blood Disorders, Vascular
Summary

The Kids-DOTT trial is a randomized controlled clinical trial whose primary objective is to evaluate non-inferiority of shortened-duration (6 weeks) versus conventional-duration (3 months) anticoagulation in children with first-episode acute venous thrombosis. The first stage of the trial has consisted of a pilot/feasibility component, which then continues as the definitively-powered trial.

Male and female patients who meet the following criteria may take part in this study:

Inclusion Criteria:
1. Children (birth to less than 21 years of age) with radiologically-confirmed acute venous thrombosis in the past 30 days
2. In the opinion of the investigator, the venous thrombosis was a provoked (i.e., non-spontaneous) event (e.g.: hospitalization; Central venous catheterization; infection; dehydration; surgery; trauma; immobility; use of estrogen-containing oral contraceptive pills; flare of autoimmune/rheumatologic condition).

Exclusion Criteria:
1. Prior episode of venous thromboembolism (VTE)
2. Presence or history of cancer
3. Systemic lupus erythematosus
4. Known pulmonary embolism (PE), except when limited to peripheral cavitary lesions representing septic emboli; (N.B. imaging for PE should only have been based upon clinical signs/symptoms, and is not a study procedure or requirement)
5. Use of, or intent to use, thrombolytic therapy
6. Patients with congenital cardiac disease involving a single or hypoplastic ventricle or otherwise requiring an intracardiac shunt
7. Moderate/severe anticoagulant deficiency as defined by any one of the following:
a. protein C less than 20 IU/dL if patient is greater than or equal to 3 months of age, or protein C below lower limit of detection if patient is less than 3 months of age;
b. antithrombin less than 30 IU/dL if patient is greater than or equal to 3 months of age, or antithrombin below lower limit of detection if patient is less than 3 months of age;
c. protein S (free antigen or activity) less than 20 IU/dL.

Study Site:
Children?s Center for Cancer & Blood Disorders / Palmetto Health Children?s Hospital
7 Richland Medical Park
Columbia, SC 29203

Study Site Principal Investigator Contact Information:
Stuart L. Cramer, DO at 803-434-3533

Institution
Palmetto
Recruitment Contact
James French
803-434-3533
Selena.Lollar@PalmettoHealth.org

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