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 has now been completed.

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 VTE
2. Malignancy that, in the opinion of the treating oncologist, is not in remission, or for which chronic anticoagulation is being administered/anticipated to be initiated within 6 months (note: remission may exist on or off anti-neoplastic therapy)
3. Systemic lupus erythematosus
4. Pulmonary embolism that is not accompanied by DVT or is more proximal than segmental branches of the pulmonary artery
5. Use of, or intent to use, thrombolytic therapy
6. History of congenital cardiac disease for which chronic anticoagulation is being administered/ anticipated to be initiated within 6 months (e.g., for select patients or centers, in the setting of a single or hypoplastic ventricle or surgically-established cardiac shunt)
7. Moderate/severe anticoagulant deficiency as defined by any one of the following:
a. protein C 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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