Evaluation of the Duration of Therapy for Thrombosis in Children

Description

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.

Study Start Date

March 2008

Estimated Completion Date

December 2020

Interventions

  • Other: Shortened duration (6 weeks) of anticoagulant therapy
  • Other: Conventional duration (3 months) of anticoagulant therapy
  • Drug: Dalteparin
  • Other: No Intervention

Specialties

  • Cardiology: Clinical Pharmacology,Vascular Medicine
  • Pediatrics: Clinical Pharmacology,Pediatric Cardiology
  • Family Medicine: Clinical Pharmacology,Peds Family Medicine
  • Physician Assistant: Cardiology,Clinical Guidelines

MeSH Terms

  • Dalteparin
  • Thrombosis
  • Venous Thrombosis

Study ID

University of Colorado, Denver -- Kids-DOTT Trial

Status

Recruiting

Trial ID

NCT00687882

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

750

Sponsor

University of Colorado, Denver

Inclusion Criteria

  • Children, aged 0-18 at time of enrollment
  • Recently-diagnosed (i.e., within 30 days of radiologic diagnosis) of first- episode acute venous thrombosis

Exclusion Criteria

  • 1) Any of the following: 1. history of premature birth, if corrected (i.e., post-conceptional) age < 36 weeks (including gestation) at time of enrollment
  • 2. pregnancy at time of enrollment (N.B.: development of pregnancy while on study will constitute post-enrollment exclusion from the study, although any data collected to that time will be retained given the intent-to-treat analytic approach) 3. known pulmonary embolism complicating this first-episode venous thrombosis 4. uncorrected anatomic vascular defect, including May-Thurner anomaly, cervical rib, and atretic IVC 5. use of thrombolytic therapy (i.e. tPA) in the treatment of this first-episode venous thrombosis 6. chronic inflammatory condition/disease, other than diabetes mellitus 7. prior episode of treated VTE 8. antiphospholipid antibody persistent at 6 weeks (anticardiolipin IgG or IgM >= 30, anti-beta-2-glycoprotein-1 IgG or IgM >= 10, or lupus anticoagulant positive by local laboratory parameters, e.g. LA1/LA2 ratio >= 1.2 by dRVVT) 9. combined elevation of factor VIII > 150 IU/dL and D-dimer > 500 ng/mL at diagnosis in patients with veno-occlusive DVT involving the extremities, iliac veins, IVC, subclavian vein, brachiocephalic vein, innominate vein, or SVC 10. history of malignancy 11. no identifiable clinical risk factor for thrombosis (see Table 1) (i.e., episode is spontaneous) 12. homozygous factor V Leiden mutation 13. homozygous prothrombin 20210 mutation 14. protein C, S, or antithrombin <= 40 % (IU/dL)
  • OR
  • 2) At least three of the following: 1. first-degree family history of VTE (full sibling or biological parent treated for VTE) 2. thrombophilia traits at most recent assessment prior to enrollment as follows (each counted individually as one risk factor): 1. factor V Leiden mutation
  • 2. prothrombin 20210 mutation 3. protein C below lower limit of normal values for age (local laboratory) 4. protein S below lower limit of normal values for age (local laboratory) 5. antithrombin III below lower limit of normal values for age (local laboratory) 6. lipoprotein(a) >= 30 mg/dL 7. homocysteine >= 14 microM 8. factor VIII > 150 IU/dL.

Gender

Both

Ages

18 Years and younger

Accepts Healthy Volunteers

No

Study Locations and Contact Information (57)

Study Location Distance Name Phone Email
Yale School of Medicine - New Haven, Connecticut 18.2 miles Karissa McLaurin None karissa.mclaurin@yale.edu
Yale School of Medicine - New Haven, Connecticut 18.2 miles None None None
Cohen Childrens Medical Center - New Hyde Park, New York 39.6 miles None None None
Cohen Childrens Medical Center - New Hyde Park, New York 39.6 miles Farisha Baksh 718-470-3439 mnarine@nshs.edu
St Christophers Hospital for Children - Philadelphia, Pennsylvania 129.6 miles Dominique C Jones 215-427-6523 dominique2.jones@tenethealth.com
St Christophers Hospital for Children - Philadelphia, Pennsylvania 129.6 miles None None None
Boston Childrens Hospital - Boston, Massachusetts 135.8 miles None None None
Boston Childrens Hospital - Boston, Massachusetts 135.8 miles Krystle Benedict 617-355-3748 krystle.benedict@childrens.harvard.edu
Cornell University - Ithaca, New York 187.8 miles None None None
Hershey Medical Center - Hershey, Pennsylvania 188.9 miles None None None
Johns Hopkins Medicine - Baltimore, Maryland 219.6 miles None None None
George Washington University Childrens National Medical Center - Washington, District of Columbia 255.3 miles None None None
George Washington University Childrens National Medical Center - Washington, District of Columbia 255.3 miles None None None
University of Pittsburgh - Pittsburgh, Pennsylvania 354.9 miles Angela Martino 412-692-6467 angela.martino2@chp.edu
University of Pittsburgh - Pittsburgh, Pennsylvania 354.9 miles None None None
Akron Childrens Hospital - Akron, Ohio 431.1 miles None None None
Rainbow Babies and Childrens Hospital - Cleveland, Ohio 434.6 miles Sally Muehle 216-983-3178 sally.muehle@uhhospitals.org
Rainbow Babies and Childrens Hospital - Cleveland, Ohio 434.6 miles None None None
Duke University - Durham, North Carolina 474.7 miles None None None
Duke University - Durham, North Carolina 474.7 miles None None None
Childrens Hospital of Michigan Wayne State University - Detroit, Michigan 512.3 miles None None None
Nationwide Childrens Hospital - Columbus, Ohio 518.1 miles None None None
Nationwide Childrens Hospital - Columbus, Ohio 518.1 miles Jessica DeJesus 614-722-3694 jessica.dejesus@nationwidechildrens.org
Michigan State University - East Lansing, Michigan 587.2 miles None None None
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 611.0 miles None None None
Helen Devos Childrens Hospital - Grand Rapids, Michigan 648.5 miles None None None
Palmetto Health - Columbia, South Carolina 651.8 miles None None None
Indiana Hemophilia and Thrombosis Center - Indianapolis, Indiana 686.2 miles None None None
Indiana Hemophilia and Thrombosis Center - Indianapolis, Indiana 686.2 miles Angie Summers 317-871-0011 asummers@ihtc.org
Medical University of South Carolina - Charleston, South Carolina 691.2 miles None None None
Kosair Childrens Hospital - Louisville, Kentucky 696.1 miles None None None
Childrens Hospital of Chicago - Chicago, Illinois 745.5 miles None None None
Rush University Medical Center - Chicago, Illinois 748.9 miles None None None
Medical College of Wisconsin Blood Center of Wisconsin - Wauwatosa, Wisconsin 769.3 miles None None None
Medical College of Wisconsin Blood Center of Wisconsin - Wauwatosa, Wisconsin 769.3 miles None None None
Emory University Childrens Healthcare of Atlanta - Atlanta, Georgia 795.6 miles Gladys Lee 404-727-9698 gladys.lee@emory.edu
Emory University Childrens Healthcare of Atlanta - Atlanta, Georgia 795.6 miles None None None
Nemours Childrens Clinic - Jacksonville, Florida 890.4 miles None None None
University of Alabama Birmingham - Birmingham, Alabama 915.7 miles None None None
University of Alabama Birmingham - Birmingham, Alabama 915.7 miles Jeanine Dumas None jeanine.dumas@childrensal.org
All Childrens Hospital - St. Petersburg, Florida 1,073.3 miles None None None
Childrens Mercy Hospital - Kansas City, Missouri 1,136.3 miles None None None
University of Miami - Miami, Florida 1,145.6 miles None None None
University of Oklahoma Health Sciences Center - Oklahoma City, Oklahoma 1,371.2 miles None None None
University of Texas Southwestern - Dallas, Texas 1,414.8 miles Anna Winborn 214-456-8185 Anna.Winborn@childrens.com
University of Texas Southwestern - Dallas, Texas 1,414.8 miles None None None
Dell Childrens Medical Center of Central Texas - Austin, Texas 1,559.8 miles None None None
University of Colorado School of Medicine - Denver, Colorado 1,658.2 miles None None None
University of Colorado School of Medicine - Denver, Colorado 1,658.2 miles None None None
Primary Childrens Medical Center - Salt Lake City, Utah 1,839.1 miles None None None
Phoenix Childrens Hospital - Phoenix, Arizona 2,181.7 miles None None None
Oregon Health Sciences University - Portland, Oregon 2,468.2 miles None None None
Rady Childrens Hospital UCSD - San Diego, California 2,469.3 miles Mehrzad Milburn None mmilburn@rchsd.org
Rady Childrens Hospital UCSD - San Diego, California 2,469.3 miles None None None
Childrens Hospital Orange County - Orange, California 2,477.9 miles None None None
Childrens Hospital Orange County - Orange, California 2,477.9 miles Brandy Gonzales 714-509-8423 bgonzales@CHOC.ORG
Childrens Hospital Los Angeles - Los Angeles, California 2,489.4 miles None None None

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