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

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-4z9wdg
• Date of registration: 07/03/2012
• Primary sponsor: Hospital do Coração da Associação do Sanatório Sirio - Sao Paulo, SP, Brazil
• Public title: Comparison among two drugs commonly used in the prevention and treatment of thrombosis, to prevent thromboembolism after total cavopulmonary operation.
• Scientific title: A comparative study of oral anticoagulants and antiplatelet prophylaxis of thrombosis and thromboembolic events in the Fontan operation using extracardiac conduit.
• Date of first enrolment: 31/01/2011
• Target sample size: 30
• Recruitment status: recruitment completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-4z9wdg/
• Study design: Preventive, parallel, two arms, open and randomized clinical trial.

Countries of recruitment

Brazil

Contacts

• Name: Cristiane Pessotti
• Affiliation: Hospital do Coração - Associação do Sanatório Sírio

• Name: Cristiane Pessotti
• Affiliation: Hospital do Coração - Associação do Sanatório Sírio

Key inclusion & exclusion 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: Patients with contraindications to receive any of the medications (sodium warfarin or aspirin)


Age minimum: 0
Age maximum: 0
Gender: -

Health Condition(s) or Problem(s) studied

Hypoplastic right heart syndrome, thrombosis, Tricuspid atresia.
Q22.6
C14.907.355.830
C14.240.400.920

Q00-Q99

Intervention(s)

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, the initial dose of 0.2 mg / kg / d, adjusted according to international normalized ratio (INR) desired 2.0 to 3.0, to complete 24 months of follow-up, and 15 patients receive antiplatelet (aspirin) in group 2 for the same period at a dose 10 mg / kg / d. In patients weighing more than 10kg at a dose of 100mg/day. Patients will be evaluated at six specific times: preoperative (time 1), the immediate postoperative period (time 2), three months after surgery (time 3), six months after surgery (time 4), 12 months postoperatively (now 5) and 24 months postoperatively (now 6).

Primary Outcome(s)

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 Outcome(s)

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)

Secondary ID(s)

082-2008

Source(s) of Monetary Support

Hospital do Coração da Associação do Sanatório Sirio - Sao Paulo, SP, Brazil

Secondary Sponsor(s)

Hospital do Coração da Associação do Sanatório Sirio - Sao Paulo, SP, Brazil