Thrombosis study in children

• Register: EUCTR
• Last refreshed on: 20 August 2018
• Main ID: EUCTR2015-001776-21-NL
• Date of registration: 28/05/2018
• Prospective Registration: Yes
• Primary sponsor: All Children`s Hospital John Hopkins Medicine (St. Petersburg, FL), All Children`s Hospital Foundation
• Public title: Thrombosis study in children
• Scientific title: Prospective Multi-Center Evaluation of the Duration of Therapy for Thrombosis in Children - The "Kids-DOTT" Trial
• Date of first enrolment: 25/07/2018
• Target sample size: 815
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001776-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: no treatment; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Argentina, Austria, Canada, Germany, Israel, Netherlands, United Kingdom, United States

Contacts

• Name: PI
• Affiliation: Medizinische Universität Wien, Universitätsklinik für

• Name: PI
• Affiliation: Medizinische Universität Wien, Universitätsklinik für

Key inclusion & exclusion 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).
Are the trial subjects under 18? yes
Number of subjects for this age range: 815
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 aintracardiac shunt
(7) Moderate/severe anticoagulant deficiency as defined by any one of the following:
a. 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;
b. 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;
c. protein S (free antigen or activity) <20 IU/dL.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Thrombosis in pediatric patients

Intervention(s)

Trade Name: Fraxiparine (Nadroparin)
Product Name: Fraxiparin (nadroparin)
Product Code: B01AB06
Pharmaceutical Form: Injection
INN or Proposed INN: Nadroparin Calcium
Other descriptive name: NADROPARIN CALCIUM
Concentration unit: U/ml unit(s)/millilitre
Concentration type: range
Concentration number: -0.5-1.0

Trade Name: Marcoumar-Tablets 3mg (Phenprocoumon)
Product Name: Marcoumar-Tablets 3mg (Phenprocoumon)
Product Code: B01AA04
Pharmaceutical Form: Tablet
INN or Proposed INN: PHENPROCOUMON
CAS Number: 435-97-2
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: -2-3

Trade Name: Heparine LEO 5.000 I.E./mL
Product Name: Heparine-Leo 5.000 I.E./mL
Product Code: B01AB01
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: HEPARIN SODIUM
CAS Number: 9041-08-1
Concentration unit: U/ml unit(s)/millilitre
Concentration type: range
Concentration number: -0.3-0.7

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Visits at 6wk, 3mo, 6 mo, 1y, 2y

Primary end point(s): PRIMARY EFFICACY: Risk of symptomatic recurrent VTE within 1 year
PRIMARY SAFETY: Risk of clinically-relevant (i.e., major plus clinically-relevant non-major [CRNM]) bleeding within 3 months (maximum randomized duration of anticoagulation) plus 10 days

Main Objective: To evaluate the efficacy and safety of shortened-duration (6 weeks total) versus conventional-duration (3 months total) anticoagulation for first-episode, provoked, acute venous thrombosis among children in whom thrombus resolution/non-occlusion (i.e. established blood flow) is evident after the initial 6 weeks of anticoagulant therapy
Hypothesis: Among children with first-episode, provoked, acute venous thrombosis in whom thrombosis is resolved or non-occlusive at six weeks follow-up, a shortened duration of anticoagulation (total six weeks; i.e. no further therapy) is non-inferior in efficacy to the conventional duration (total three months) of anticoagulation with respect to the risk of symptomatic recurrent VTE at 1 year, and is superior in safety with respect to the risk of clinically-relevant bleeding.(The hypothesis will also be tested in secondary analysis at 2 years, using the same efficacy and safety outcomes as for the 1 year primary analysis.)

Secondary Objective: Post-thrombotic syndrome, using Manco-Johnson Instrument

Secondary Outcome(s)

Secondary end point(s): SECONDARY SAFETY:
1) Major bleeding episode (defined as above)
2) Minor bleeding episode (defined as all clinically-evident bleeding episodes not meeting criteria for Major or CRNM bleeding, above) within the therapy period. Nosebleeds lasting = 15 minutes, bleeding from superficial lacerations, and bruising at points of minor trauma are all considered as expected events on anticoagulation, and accordingly will not be collected.
SECONDARY EFFICACY:
1) Risk of symptomatic recurrent VTE at 2 years
2) Risks of PTS at 1 year and 2 years

Timepoint(s) of evaluation of this end point: Visits at 6wk, 3mo, 6 mo, 1y, 2y

Secondary ID(s)

2015-001776-21-AT

KidsDOTT

NCT00687882

Source(s) of Monetary Support

Medical University of Vienna