A Prospective, Open-Label, Single-Arm, Multi-Center Study To Assess The Pharmacokinetics/Pharmacodynamics (PK/PD) And Safety Of Different Cangrelor Doses In Neonatal Subjects At Risk Of Thrombosis

The purpose of this study is to assess the PK/PD and safety profile of cangrelor in neonatal participants at risk of thrombosis.

开始日期2017-01-03

申办/合作机构

CHIESI Farmaceutici SpA

100 项与全身性至肺动脉分流术完全梗阻相关的临床结果

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100 项与全身性至肺动脉分流术完全梗阻相关的转化医学

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0 项与全身性至肺动脉分流术完全梗阻相关的专利（医药）

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项与全身性至肺动脉分流术完全梗阻相关的文献（医药）

2024-11-01·Journal of Cardiothoracic and Vascular Anesthesia

Anesthetic Management for Aspiration Thrombectomy Using the Penumbra Indigo System in Pediatric Patients with Congenital Heart Disease

Article

作者: Zaleski, Katherine L ; Stein, Mary Lyn ; Esch, Jesse J

OBJECTIVETo describe clinical characteristics and outcomes, including transfusion requirements, in pediatric patients with congenital heart disease undergoing aspiration thrombectomy.DESIGNRetrospective chart review.SETTINGQuaternary academic children's hospital.PARTICIPANTSPatients aged <18 years with congenital heart disease undergoing aspiration thrombectomy between November 2017 and February 2022.MEASUREMENTS AND MAIN RESULTSThirteen patients underwent mechanical thrombectomy with the Penumbra Indigo System. Their median age was 3.8 years, and median weight was 15.2 kg. Seven patients had palliated single ventricle circulation, and 6 had biventricular circulation. Nine patients had intensive care unit (ICU) admission before the procedure, and 12 required ICU admission after the procedure. Indications for thrombectomy included systemic venous thrombus in 7 patients, pulmonary arterial thrombus in 3 patients, systemic arterial thrombus in 2 patients, and systemic-to-pulmonary shunt occlusion in 1 patient. The median estimated blood loss was 7.7 mL/kg (interquartile range [IQR], 1.4-15.8 mL/kg; range, 0.5-51.5 mL/kg). Seven patients required intraoperative transfusion of packed red blood cells (n = 4), fresh frozen plasma (n = 2), platelets (n = 3), and/or cryoprecipitate (n = 1). In the patients requiring transfusion, the median transfusion volume was 22 mL/kg (IQR, 14.1-59.7 mL/kg, 9.3-132.8 mL/kg). Thrombectomy was successful in 8 of 13 patients, although 3 of these 8 patients experienced recurrent thrombosis.CONCLUSIONSMechanical aspiration thrombectomy is being increasingly used to treat critically ill pediatric patients and presents unique anesthetic considerations, particularly related to the need for volume and blood product resuscitation.

2023-11-01·JACC: Advances

Timely PAH Identification in Adults With Repaired Congenital Heart Disease? The ACHD-QuERI Registry Insights

Article

作者: Opotowsky, Alexander R ; Daniels, Curt J ; Landzberg, Michael J ; Forfia, Paul ; McLaughlin, Vallerie V ; Bell Lynum, Karimah S ; Selej, Mona

BackgroundThe Quality Enhancement Research Initiative (QuERI) in adults with congenital heart disease (ACHD) was developed to improve detection of pulmonary arterial hypertension (PAH) after repair of systemic-to-pulmonary arterial shunt lesions.ObjectivesThis study sought to standardize use of accepted criteria for PAH diagnosis and evaluate utility in at-risk patients with ACHD.MethodsPatients ≥18 years of age with ACHD repaired ≥1 year before enrollment and with additional risk factors for developing PAH were eligible. History, physical examination, electrocardiogram, transthoracic echocardiogram, World Health Organization functional class, and 6-minute walk distance were evaluated at baseline and yearly for 3 years. Pop-up reminders of patient-specific evidence-based recommendations for PAH detection appeared during data entry.ResultsAmong 217 eligible patients, mean age (enrollment) was 44.0 ± 15.9 years, 72.3% were women, and 82.0% were World Health Organization functional class I. Electrocardiogram was performed in >80% and TTE in >70% of patients annually; capture of required transthoracic echocardiography (TTE) measures and alignment between study- and core-center interpretation improved over time, with more frequent assessment of pulmonary arterial flow acceleration time and documentation of right ventricular outflow tract Doppler notching. Approximately 40% of patients had ≥2 high-risk features for PAH on TTE, but only 7% (6/82) underwent right heart catheterization (RHC). Using current definitions, 2 patients were confirmed by RHC to have a diagnosis of PAH (maximum follow-up 3 years).ConclusionsA structured protocol may improve screening for patients with repaired ACHD at risk of developing PAH. RHC may be underutilized in patients with ACHD with TTE findings suggestive of PAH. (Adult Congenital Heart Disease Registry [QuERI]; NCT01659411).

2022-11-03·European Journal of Cardio-Thoracic Surgery

Systemic-to-pulmonary artery shunt stenosis: prevention is better than cure

Communications

作者: Dasgupta, Soham ; Alsoufi, Bahaaldin