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Evaluation of the Duration of Therapy for Thrombosis in Children (Kids-DOTT)

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ClinicalTrials.gov Identifier: NCT00687882
Recruitment Status : Recruiting
First Posted : June 2, 2008
Last Update Posted : March 23, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Neil Goldenberg, Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Venous Thrombosis Other: Shortened duration (6 weeks) of anticoagulant therapy Other: Conventional duration (3 months) of anticoagulant therapy Other: No Intervention Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Multi-Center Evaluation of the Duration of Therapy for Thrombosis in Children
Study Start Date : March 2008
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intervention: A
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Other: 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.
Active Comparator: B
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Other: 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.
Parallel Cohort: Persistent Occlusive Thrombosis
Patients with completely occlusive thrombosis at 6 weeks.
Other: 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.
Parallel Cohort: Persistent Antiphospholipid Antibody
Patients with persistent Positive Antiphospholipid Antibody at 6 weeks.
Other: 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.



Primary Outcome Measures :
  1. Bivariate endpoint. [ Time Frame: 1 Year ]

    Primary efficacy endpoint is the risk of symptomatic, radiologically-confirmed recurrent venous thromboembolism.

    Primary safety endpoint is clinically-relevant bleeding (major + clinically-relevant non-major).



Secondary Outcome Measures :
  1. Prevalence/severity of post-thrombotic syndrome. [ Time Frame: 1 and 2 Years ]
    PTS is measured using a standardized validated pediatric outcome instrument (Manco-Johnson instrument). Both PTS and clinically-significant PTS will be captured as secondary endpoints.



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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children (birth to <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. 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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00687882


Contacts
Contact: Neil A Goldenberg, MD, PhD 727-767-6886 neil@jhmi.edu
Contact: Frances L Hamblin, MSHS, RN 727-767-2460 Frances.Hamblin@jhmi.edu

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Jeanine Dumas       jeanine.dumas@childrensal.org   
Principal Investigator: Lee Hillard, MD         
United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Erica Olson    602-933-0171    eolson1@phoenixchildrens.com   
Principal Investigator: Christine Knoll, MD         
United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Juan Portillo       juanportillo@chla.usc.edu   
Principal Investigator: Guy Young, MD         
Children's Hospital Orange County Recruiting
Orange, California, United States, 92868
Contact: Brandy Gonzales    714-509-8423    bgonzales@CHOC.ORG   
Principal Investigator: Arash Mahajarin, MD         
Stanford Medicine Not yet recruiting
Palo Alto, California, United States, 34304
Contact: Elaine Macasiray       emacasiray@stanford.edu   
Principal Investigator: Clara Lo, MD         
Rady Children's Hospital UCSD Recruiting
San Diego, California, United States, 92123
Contact: Mehrzad Milburn       mmilburn@rchsd.org   
Principal Investigator: Courtney Thornburg, MD         
United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: Karissa McLaurin       karissa.mclaurin@yale.edu   
Principal Investigator: Sally Pels, MD         
United States, District of Columbia
George Washington University, Children's National Medical Center Terminated
Washington, District of Columbia, United States, 20010
United States, Florida
Nemours Children's Clinic Recruiting
Jacksonville, Florida, United States, 32207
Contact: Lori Hodges       lori.hodges@nemours.org   
Principal Investigator: Cindy Gauger, MD         
University of Miami Recruiting
Miami, Florida, United States, 33124
Contact: Leandro Pisani    305-243-6925    lfp34@miami.edu   
Principal Investigator: Fernando Corrales-Medina, MD         
Johns Hopkins All Children's Hospital Recruiting
St. Petersburg, Florida, United States, 33701
Contact: Laurie Barrett    727-767-3213    laurie.barrett@jhmi.edu   
Contact: Jade Hanson       Jade.Hanson@jhmi.edu   
Principal Investigator: Neil Goldenberg, MD         
United States, Georgia
Emory University / Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Contact: Gladys Lee    404-727-9698    gladys.lee@emory.edu   
Principal Investigator: Kavita Patel, MD         
United States, Illinois
Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Devin Muntz       dmuntz@luriechildrens.org   
Principal Investigator: Rukhmi Bhat, MD         
Rush University Medical Center Terminated
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana Hemophilia and Thrombosis Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Angie Summers    317-871-0011 ext 218    asummers@ihtc.org   
Principal Investigator: Charles Nakar, MD         
United States, Kentucky
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Helen Lynn Anderkin       helen.anderkin@louisville.edu   
Principal Investigator: Arun Panigrahi, MD         
United States, Maryland
Johns Hopkins Medicine Recruiting
Baltimore, Maryland, United States, 21287
Contact: Stephanie Fleckinger    443-287-8985    scohen54@jhmi.edu   
Principal Investigator: Cliff Takemoto, MD         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Krystle Benedict    617-355-3748    krystle.benedict@childrens.harvard.edu   
Principal Investigator: Cameron Trenor, MD         
United States, Michigan
Children's Hospital of Michigan, Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Kristy Enderlan    313-966-8393    kenderle@dmc.org   
Principal Investigator: Madhvi Rajpurkar, MD         
Michigan State University Recruiting
East Lansing, Michigan, United States, 48824
Contact: Julie Rose    517-432-5126    Julie.Rose@hc.msu.edu   
Principal Investigator: Ajovi Scott Emuakpor, MD         
Helen Devos Children's Hospital Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Emily Gleason    616-391-5075    emily.gleason@helendevoschildrens.org   
Principal Investigator: Deanna Mitchell, MD         
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Robin Ryan    816-802-1474    rryan@cmh.edu   
Principal Investigator: Shannon Carpenter, MD         
United States, New Jersey
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Cynthia Horta       chorta@barnabashealth.org   
Principal Investigator: Shalu Narang, MD         
United States, New York
The Children's Hospital at Montefiore Recruiting
Bronx, New York, United States, 10467-2403
Contact: Karen Ireland       Kireland@montefiore.org   
Principal Investigator: Jennifer Davila, MD         
Cornell University Recruiting
Ithaca, New York, United States, 14850
Contact: Fraustina Hsu    212-746-4126    frh2005@med.cornell.edu   
Principal Investigator: Nicole Kucine, MD         
Cohen Children's Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Maria Narine    718-470-3439    mnarine@nshs.edu   
Principal Investigator: Suchitra Acharya, MD         
NewYork-Presbyterian Not yet recruiting
New York, New York, United States, 10032
Contact: Cindy Neunert         
Principal Investigator: Cindy Neunert, MD         
Golisano Children's Hospital Recruiting
Rochester, New York, United States, 14642
Contact: Akua Asanta    585-275-2981    Akua_asante@URMC.Rochester.edu   
Principal Investigator: Criag Mullen, MD         
United States, North Carolina
Duke University Terminated
Durham, North Carolina, United States, 27710
United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44308
Contact: Jill Bradisse       jbradisse@chmca.org   
Principal Investigator: John Fargo, MD         
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Ann Pilllow    513-636-6719    anngreene.pillow@cchmc.org   
Principal Investigator: Christina Tarango, MD         
Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Sally Muehle    216-983-3178    sally.muehle@uhhospitals.org   
Principal Investigator: Sanjay Ahuja, MD         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Jessica DeJesus    614-722-3694    jessica.dejesus@nationwidechildrens.org   
Principal Investigator: Sarah O'Brien, MD         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Cynthia Hodge       cynthia-hodge@ouhsc.edu   
Principal Investigator: Osman Kahn, MD         
United States, Oregon
Oregon Health Sciences University Recruiting
Portland, Oregon, United States, 97239
Contact: Kathy Beach    503-494-7425    beachk@ohsu.edu   
Principal Investigator: Kristina Haley, MD         
United States, Pennsylvania
Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Jennifer Stokes    717-531-7765    jstokes1@hmc.psu.edu   
Principal Investigator: Frederico Xavier, MD         
St. Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Dominique C. Jones    215-427-6523    dominique2.jones@tenethealth.com   
Principal Investigator: Deepti Raybagkar, MD         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Angela Martino    412-692-6467    angela.martino2@chp.edu   
Principal Investigator: Lynn Malec, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Elizabeth Shewfelt       shewfelt@musc.edu   
Principal Investigator: Shayla Bergmann, MD         
Palmetto Health Recruiting
Columbia, South Carolina, United States, 29203
Contact: Selena Lollar    803-434-3685    selena.lollar@palmettohealth.org   
Principal Investigator: Jim French, MD         
United States, Texas
Dell Children's Medical Center of Central Texas Recruiting
Austin, Texas, United States, 78723
Contact: Rhea Robinson       RMRobinson@seton.org   
Principal Investigator: Robert Mignacca, MD         
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Anna Winborn    214-456-8185    Anna.Winborn@childrens.com   
Principal Investigator: Janna Journeycake, MD         
Texas Children's Hospital (Baylor) Terminated
Houston, Texas, United States, 77030
United States, Utah
Primary Children's Medical Center Recruiting
Salt Lake City, Utah, United States, 81432
Contact: Rebbecca Perez    801-587-7759    Rebbecca.perez@hsc.utah.net   
Principal Investigator: Anupam Verma, MD         
United States, Virginia
Children's Hospital of The King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Sabrina Wigginton    757-668-7909    Sabrina.Wigginton@chkd.org   
Principal Investigator: Gary Woods, MD         
United States, Wisconsin
Medical College of Wisconsin, Blood Center of Wisconsin Terminated
Wauwatosa, Wisconsin, United States, 53226
Australia
Royal Children's Hospital Recruiting
Parkville VIC, Australia
Contact: Michele Hipponstall         
Contact       michele.hepponstall@rch.org.au   
Principal Investigator: Paul Monagle, MD         
Austria
Medizinishe Universitat Wien Recruiting
Vienna, Austria
Contact: Eva Wissman       eva.wissman@meduinwien.ac.at   
Principal Investigator: Christoph Male, MD         
Canada, Alberta
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Anna Shirokova       shirokova@ualberta.ca   
Principal Investigator: Patti Massicotte, MD         
Canada, Ontario
McMaster Childrens Hospital Recruiting
Hamilton, Ontario, Canada
Contact: Kim Nagel    905-521-2100 ext 76054    nagel@hhsc.ca   
Principal Investigator: Anthony Chan, MD         
SickKids Not yet recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Celeste Lumia       celeste.lumia@sickkids.ca   
Principal Investigator: Leonardo Brandao, MD         
Israel
Hadassah Hebrew-University Hospital Recruiting
Jerusalem, Israel
Contact: Limor Oren       limoro@hadassah.org.il   
Contact: Hila Yossef       hilay@hadassah.org.il   
Principal Investigator: Shoshana Revel-Vilk, MD         
Sheba Medical Center Recruiting
Tel-Aviv, Israel
Contact: Shirley Azar Avivi       shirley.azaravivi@sheba.health.gov.il   
Principal Investigator: Gili Kenet, MD         
Netherlands
Sophia Children's Hospital Not yet recruiting
Rotterdam, Netherlands
Contact: Christa de Leeuw-Slingerland       beheer.kocr@erasmusmc.nl   
Principal Investigator: Heleen Van Ommen, MD         
Sponsors and Collaborators
Johns Hopkins All Children's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Neil A Goldenberg, MD, PhD Johns Hopkins All Children's Hospital

Additional Information:
Publications:
Responsible Party: Neil Goldenberg, Director of Research and Chief Research Officer, Johns Hopkins All Children's Hospital, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00687882     History of Changes
Other Study ID Numbers: IRB00063928
1U01HL130048-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2008    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Neil Goldenberg, Johns Hopkins University:
Venous Thromboembolism
Postthrombotic Syndrome
Antithrombotic Therapy
Duration of Therapy
Children

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Antibodies
Antibodies, Antiphospholipid
Anticoagulants
Immunologic Factors
Physiological Effects of Drugs