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Comparison among two drugs commonly used in the prevention and treatment of thrombosis, to prevent thromboembolism after total cavopulmonary operation.

A comparative study of oral anticoagulants and antiplatelet prophylaxis of thrombosis and thromboembolic events in the Fontan operation using extracardiac conduit.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4z9wdg
Enrollment
Unknown
Registered
2012-03-07
Start date
2011-01-31
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoplastic right heart syndrome, thrombosis, Tricuspid atresia.

Interventions

Thirty patients undergoing the total cavopulmonary shunt will be divided into two groups: 15 patients will receive oral anticoagulant (warfarin sodium) in group 1 from the first day after surgery, th
drug
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D03.438.150.446.520.914

Sponsors

Hospital do Coração da Associação do Sanatório Sirio
Lead Sponsor
Hospital do Coração da Associação do Sanatório Sirio
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Scheduling total cavopulmonary operation according to the clinical criteria for surgery. Parents or guardians agree to the inclusion in the study.

Exclusion criteria

Exclusion criteria: Patients with contraindications to receive any of the medications (sodium warfarin or aspirin)

Design outcomes

Primary

MeasureTime frame
Absence of thrombosis inside of the extra-cardíac conduit, diagnosed by transesophageal echocardiography: analyzed by one examiner to assess the absence of thrombus imaging in light of extra-cardiac conduit. Absence of thrombosis inside of the extra-cardíac conduit diagnosed by CT angiography: acquisition with only carried out by one examiner with contrast, evaluating the absence of thrombus in the lumen or adhered to the wall of the extra-cardíac conduit.—

Secondary

MeasureTime frame
Absence of subclinical thromboembolism diagnosed by scintigraphy ventilation-perfusion, assessed by one examiner. The interpretation criteria follow the standardization scheme Nuclear Medicine Service of the Heart Hospital of Syrian Sanatorium Association, according to guidelines established by prospective investigation of pulmonary embolism diagnosis (PIOPED)—

Countries

Brazil

Contacts

Public ContactCristiane Pessotti

Hospital do Coração - Associação do Sanatório Sírio

crisximenes08@gmail.com11-3053661/ r 2631

Outcome results

None listed

Source: REBEC (via WHO ICTRP)