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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00687882




Registration number
NCT00687882
Ethics application status
Date submitted
6/05/2008
Date registered
2/06/2008
Date last updated
2/03/2022

Titles & IDs
Public title
Evaluation of the Duration of Therapy for Thrombosis in Children
Scientific title
Prospective Multi-Center Evaluation of the Duration of Therapy for Thrombosis in Children
Secondary ID [1] 0 0
1U01HL130048-01A1
Secondary ID [2] 0 0
IRB00063928
Universal Trial Number (UTN)
Trial acronym
Kids-DOTT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Shortened duration (6 weeks) of anticoagulant therapy
Other interventions - Conventional duration (3 months) of anticoagulant therapy
Other interventions - No Intervention
Other interventions - No Intervention

Experimental: Intervention: A - Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.

Active comparator: B - Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.

Other: Parallel Cohort: Persistent Occlusive Thrombosis - Patients with completely occlusive thrombosis at 6 weeks.

Other: Parallel Cohort: Persistent Antiphospholipid Antibody - Patients with persistent Positive Antiphospholipid Antibody at 6 weeks.


Other interventions: Shortened duration (6 weeks) of anticoagulant therapy
Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 6 weeks.

Other interventions: Conventional duration (3 months) of anticoagulant therapy
Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 3 months.

Other interventions: No Intervention
Subjects with evidence of persistent thrombus at 6 weeks time will remain on anticoagulant therapy for 3-6 months at the discretion of their treating physician.

Other interventions: No Intervention
Subjects with evidence of persistent antiphospholipid antibody at 6 weeks will remain on anticoagulant therapy for 3 months to indefinite duration, at the discretion of their treating physician.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy outcome - Occurrence of symptomatic recurrent venous thromboembolism
Timepoint [1] 0 0
1 Year
Primary outcome [2] 0 0
Safety outcome - Occurrence of clinically-relevant (i.e. major plus clinically-relevant non-major [CRNM]
Timepoint [2] 0 0
1 year
Secondary outcome [1] 0 0
Efficacy outcome 1 - Occurrence of symptomatic recurrent venous thromboembolism (VTE) or development of Post Thrombotic Syndrome (PTS) (composite endpoint)
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Efficacy outcome 2 - Occurrence of symptomatic recurrent venous thromboembolism (VTE)
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Efficacy outcome 3 - Development of Post Thrombotic Syndrome (PTS)
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Efficacy outcome 4 - Development of Post Thrombotic Syndrome (PTS)
Timepoint [4] 0 0
2 years

Eligibility
Key inclusion criteria
1. Children (birth to <21 years of age) with radiologically-confirmed acute deep 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).
Minimum age
No limit
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior episode of VTE
2. Malignancy that, in the opinion of the treating oncologist, is not in remission (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. Chronic anticoagulant at prophylactic dosing is being or will be administered beyond 6 months post VTE diagnosis
7. Moderate/severe anticoagulant deficiency (defined by any one of the following):

1. protein C <20 IU/dL if patient is =3 months of age, or protein C below lower limit of detection if patient is <3 months of age;
2. antithrombin <30 IU/dL if patient is =3 months of age, or antithrombin below lower limit of detection if patient is <3 months of age;
3. protein S (free antigen or activity) <20 IU/dL.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/02/2022
Sample size
Target
Accrual to date
Final
608
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Iowa
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Montana
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oklahoma
Country [24] 0 0
United States of America
State/province [24] 0 0
Oregon
Country [25] 0 0
United States of America
State/province [25] 0 0
Pennsylvania
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Wisconsin
Country [32] 0 0
Austria
State/province [32] 0 0
Vienna
Country [33] 0 0
Canada
State/province [33] 0 0
Alberta
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Israel
State/province [36] 0 0
Jerusalem
Country [37] 0 0
Israel
State/province [37] 0 0
Tel-Aviv
Country [38] 0 0
Netherlands
State/province [38] 0 0
Rotterdam

Funding & Sponsors
Primary sponsor type
Other
Name
Johns Hopkins All Children's Hospital
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT00687882
Trial related presentations / publications
Goldenberg NA, Tripputi M, Crowther M, Abshire TC, DiMichele D, Manco-Johnson MJ, Hiatt WR. The "parallel-cohort RCT": Novel design aspects and application in the Kids-DOTT trial of pediatric venous thromboembolism. Contemp Clin Trials. 2010 Jan;31(1):131-3. doi: 10.1016/j.cct.2009.11.006. Epub 2009 Nov 24.
Kittelson JM, Spyropoulos AC, Halperin JL, Kessler CM, Schulman S, Steg G, Turpie AG, Cutler NR, Hiatt WR, Goldenberg NA; Antithrombotic Trials Leadership and Steering (ATLAS) Group. Balancing risk and benefit in venous thromboembolism trials: concept for a bivariate endpoint trial design and analytic approach. J Thromb Haemost. 2013 Aug;11(8):1443-8. doi: 10.1111/jth.12324.
Goldenberg NA, Abshire T, Blatchford PJ, Fenton LZ, Halperin JL, Hiatt WR, Kessler CM, Kittelson JM, Manco-Johnson MJ, Spyropoulos AC, Steg PG, Stence NV, Turpie AG, Schulman S; Kids-DOTT Trial Investigators. Multicenter randomized controlled trial on Duration of Therapy for Thrombosis in Children and Young Adults (the Kids-DOTT trial): pilot/feasibility phase findings. J Thromb Haemost. 2015 Sep;13(9):1597-605. doi: 10.1111/jth.13038. Epub 2015 Aug 11.
Goldenberg NA, Kittelson JM, Abshire TC, Bonaca M, Casella JF, Dale RA, Halperin JL, Hamblin F, Kessler CM, Manco-Johnson MJ, Sidonio RF, Spyropoulos AC, Steg PG, Turpie AGG, Schulman S; Kids-DOTT Trial Investigators and the ATLAS Group. Effect of Anticoagulant Therapy for 6 Weeks vs 3 Months on Recurrence and Bleeding Events in Patients Younger Than 21 Years of Age With Provoked Venous Thromboembolism: The Kids-DOTT Randomized Clinical Trial. JAMA. 2022 Jan 11;327(2):129-137. doi: 10.1001/jama.2021.23182. Erratum In: JAMA. 2022 Mar 22;327(12):1188. doi: 10.1001/jama.2022.3496.
Public notes

Contacts
Principal investigator
Name 0 0
Neil A Goldenberg, MD, PhD
Address 0 0
Johns Hopkins All Children's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00687882