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Sponsors and Collaborators: |
University of Colorado at Denver and Health Sciences Center Children's Hospital of Michigan Children's Hospital of Philadelphia Children's Hospital of The King's Daughters Children's Hospital Los Angeles Children's Hospital Medical Center, Cincinnati Cook Children's Medical Center Cornell University Emory University Massachusetts General Hospital Medical College of Wisconsin Michigan State University Oregon Health and Science University Phoenix Children's Hospital Rush Memorial Hospital University of Arizona University of New Mexico University of Pittsburgh University of Washington Vanderbilt University |
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Information provided by: | University of Colorado at Denver and Health Sciences Center |
ClinicalTrials.gov Identifier: | NCT00687882 |
The main purpose of the Kids-DOTT trial is to provide key evidence for the optimal duration of anticoagulant therapy for thrombosis in children, given that the conventional duration of such therapy in children is derived solely from evidence in adult thrombosis trials.
Study hypothesis: Among children with first-episode acute venous thrombosis in whom thrombus resolution is evident following the initial 6 week period of anticoagulant therapy, the cumulative incidences of recurrent venous thromboembolism (VTE) and post-thrombotic syndrome (PTS) at 2 years is not significantly different between those receiving 6 weeks and those receiving 3 months total duration of anticoagulant therapy.
Condition | Intervention | Phase |
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Venous Thrombosis |
Other: Shortened duration (6 weeks) of anticoagulant therapy Other: Conventional duration (3 months) of anticoagulant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Prospective Multi-Center Evaluation of the Duration of Therapy for Thrombosis in Children |
Estimated Enrollment: | 1250 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | March 2018 |
Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Patients with thrombus resolution at 6 weeks: Total duration of anticoagulant therapy (unfractionated heparin, dalteparin (Fragmin), enoxaparin (Lovenox), OR warfarin (Coumadin)) of 6 weeks (shortened-duration arm).
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Other: Shortened duration (6 weeks) of anticoagulant therapy
Subjects with evidence of complete thrombus resolution at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy (unfractionated heparin, dalteparin (Fragmin), enoxaparin (Lovenox), OR warfarin (Coumadin)) of 6 weeks.
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B: Active Comparator
Patients with thrombus resolution at 6 weeks: Total duration of anticoagulant therapy (unfractionated heparin, dalteparin (Fragmin), enoxaparin (Lovenox), OR warfarin (Coumadin)) of 3 months (conventional duration arm).
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Other: Conventional duration (3 months) of anticoagulant therapy
Subjects with evidence of complete thrombus resolution at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy (unfractionated heparin, dalteparin (Fragmin), enoxaparin (Lovenox), OR warfarin (Coumadin)) of 3 months.
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C: No Intervention
If patients have persistent thrombosis at 6 weeks they default to conventional anticoagulant therapy (unfractionated heparin, dalteparin (Fragmin), enoxaparin (Lovenox), OR warfarin (Coumadin)) per standard of care (3 month duration).
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The trial specifically addresses the population of children with first-episode venous thrombosis in whom clinical characteristics do not indicate an a priori heightened risk for developing recurrent venous thromboembolism (VTE) or the post-thrombotic syndrome (PTS). As such, this trial adopts a rational, risk-stratified approach to antithrombotic therapy in children. In particular, it excludes patients in whom findings on initial diagnostic evaluation warrant a prolonged duration of anticoagulation, and then takes advantage of an additional clinical factor (early thrombus resolution) to target a group of children who are most likely to realize a net benefit (from the risk/benefit perspective) of shortened-duration anticoagulation. A subanalysis will evaluate outcomes related to specific anticoagulant agent used in subacute therapy for thrombosis, stratified by duration of therapy.
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
1) Any of the following:
protein C, S, or antithrombin ≤ 40 % (IU/dL)
2) At least three of the following:
thrombophilia traits at most recent assessment prior to enrollment as follows (each counted individually as one risk factor):
Contact: Neil A Goldenberg, MD | 303-724-0365 | neil.goldenberg@uchsc.edu |
Contact: Meghan J Calhoon, MS | 303-724-1327 | meghan.calhoon@uchsc.edu |
United States, Colorado | |
University of Colorado Denver Health Sciences Center | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Neil A Goldenberg, MD 303-724-0365 neil.goldenberg@uchsc.edu | |
Contact: Meghan J Calhoon, MS 303-724-1327 meghan.calhoon@uchsc.edu | |
Principal Investigator: Neil A Goldenberg, MD |
Principal Investigator: | Neil A Goldenberg, MD | University of Colorado Denver Health Sciences Center |
Responsible Party: | University of Colorado at Denver and Health Sciences Center ( Neil A. Goldenberg, MD ) |
Study ID Numbers: | Kids-DOTT Trial |
Study First Received: | May 6, 2008 |
Last Updated: | May 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00687882 |
Health Authority: | United States: Food and Drug Administration |
Venous Thromboembolism Postthrombotic Syndrome Antithrombotic Therapy Duration of Therapy Children |
Heparin, Low-Molecular-Weight Vascular Diseases Postthrombotic Syndrome Warfarin Venous Thromboembolism Thrombosis Thromboembolism Enoxaparin |
Calcium heparin Embolism and Thrombosis Dalteparin Embolism Venous Thrombosis Heparin Postphlebitic Syndrome |
Cardiovascular Diseases |