pulmonary embolism thrombosis
Conditions
Interventions
If radiological investigation does not show thrombosis anymore after 6 weeks
and lupus anticoagulans is negative, the patient can be randomized to group A (
stop anticoagulation) or group B (standar
anticoagulation
children
thrombosis
Sponsors
All Childrens Hospital Johns Hopkins Medicine
Eligibility
Age
2 Years to 17 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Based upon ISTH standardized definitions for pediatric trials [Mitchell et al., 2011], *Major bleeding* will be characterized by bleeding satisfying any one of the following criteria: 1) fatal; 2) clinically overt and associated with a decrease in hemoglobin of at least 2 g/dL in a 24 hour period; 3) clinically overt and for which blood product is administered; 4) retroperitoneal, pulmonary, or involving the central nervous system; 5) requiring surgical intervention in an operating suite. *CRNM bleeding* definition includes any bleeding that does not fulfill the above criteria but fulfills one of the following: 1) Bleeding requiring medical or surgical intervention to restore hemostasis; 2) Bleeding for which medical attention is sought. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Argentina, Austria, Canada, Germany, Netherlands, United Kingdom, United States of America
Outcome results
None listed