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Pediatric Heart Network - The Hospital for Sick Children, Toronto

Award Number: U10HL109777
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2011
PERIOD OF PERFORMANCE END DATE: 12/31/2016

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Pediatric Heart Network - The Hospital for Sick Children, Toronto - DESCRIPTION (provided by applicant): Thrombosis and thrombosis-related complications are under-recognized, yet contribute important morbidity and mortality for children with congenital heart disease. Patients with functional single ventricle undergoing palliative staging procedures towards eventual Fontan procedure are at particularly high risk, with 40% having clinically important thrombosis events before reaching superior cavopulmonary connection (SCPC), and a further 28% having events up to Fontan. The use of thromboprophylaxis is limited by lack of a sufficient evidence base and suboptimal risk-benefit ratio of currently used agents. An innovative 2 step randomized double blind clinical trial utilizing new agents is proposed to rigorously address this significant problem. For Step 1, subjects with functional single ventricle who are expected to proceed to SCPC will be enrolled at the time of initial presentation and diagnosis, and randomized to prasugrel or dabigatrin after baseline thrombophilia and genetics assessment. Subjects will be monitored up to SCPC for the primary outcome of clinically important thrombosis events, as well as compliance and bleeding complications. For Step 2, remaining subjects will have their assigned study drug discontinued just before SCPC, and after SCPC will be randomized to prasugrel or dabigatran. Surveillance vascular ultrasound will be obtained 4-10 days after SCPC, and subjects will be followed to 18 months of age with monitoring for the primary outcome, compliance and bleeding complications. At 18 months of age, surveillance vascular ultrasound and neurodevelopmental assessment will be obtained. Competing risks methodology will be used for data analysis to determine relative hazard reduction for time-related clinically important thrombosis events both for Step 1 and Step 2. The study will have 85% power to detect a 25% and 33% relative risk reduction for Step 1 and Step 2, respectively. Risk (bleeding)/benefit (thrombosis prevention) ratios will be also be compared. Factors (thrombophilia, genetic polymorphisms) associated with thrombosis and risk/benefit will be explored. This study will be an important contribution to the evidence base, study the use of novel agents in a high risk population, and identify factors that will enable risk-stratification and improved outcomes.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2021 ( Subtotal = -$1 )
2021	2015	HOSPITAL FOR SICK CHILDREN, THE	555 UNIVERSITY AVE	TORONTO	ON			CAN	Cardiovascular Diseases Research	002	5	10/3/2020	NON-COMPETING CONTINUATION	$1
2021	2015	HOSPITAL FOR SICK CHILDREN, THE	555 UNIVERSITY AVE	TORONTO	ON			CAN	Cardiovascular Diseases Research	000	5	10/1/2020	NON-COMPETING CONTINUATION	-$1
2021	2015	HOSPITAL FOR SICK CHILDREN, THE	555 UNIVERSITY AVE	TORONTO	ON			CAN	Cardiovascular Diseases Research	001	5	10/3/2020	NON-COMPETING CONTINUATION	-$1
														Subtotal = -$1

Issue Date FY: 2017 ( Subtotal = -$17,134 )
2017	2015	HOSPITAL FOR SICK CHILDREN, THE	555 UNIVERSITY AVE	TORONTO	ON	M5G 1X8		CAN	Cardiovascular Diseases Research	001	5	9/22/2017	NON-COMPETING CONTINUATION	-$17,134
2017	2015	HOSPITAL FOR SICK CHILDREN, THE	555 UNIVERSITY AVE	TORONTO	ON	M5G 1X8		CAN	Cardiovascular Diseases Research	000	5	12/22/2016	NON-COMPETING CONTINUATION	$0
														Subtotal = -$17,134

Issue Date FY: 2015 ( Subtotal = $323,911 )
2015	2015	HOSPITAL FOR SICK CHILDREN, TORONTO	555 UNIVERSITY AVENUE	TORONTO, ONTARIO				CAN	Cardiovascular Diseases Research	000	5	6/18/2015	NON-COMPETING CONTINUATION	$319,054
2015	2015	HOSPITAL FOR SICK CHILDREN, TORONTO	555 UNIVERSITY AVENUE	TORONTO, ONTARIO				CAN	Cardiovascular Diseases Research	001	5	6/23/2015	NON-COMPETING CONTINUATION	$4,857
														Subtotal = $323,911

Issue Date FY: 2014 ( Subtotal = $323,911 )
2014	2014	HOSPITAL FOR SICK CHILDREN, TORONTO	555 UNIVERSITY AVENUE	TORONTO, ONTARIO				CAN	Cardiovascular Diseases Research	000	4	6/4/2014	NON-COMPETING CONTINUATION	$323,911
														Subtotal = $323,911

Issue Date FY: 2013 ( Subtotal = $323,911 )
2013	2013	HOSPITAL FOR SICK CHILDREN, TORONTO	555 UNIVERSITY AVENUE	TORONTO, ONTARIO				CAN	Cardiovascular Diseases Research	001	3	8/2/2013	EXTENSION WITH OR WITHOUT FUNDS	$15,547
2013	2013	HOSPITAL FOR SICK CHILDREN, TORONTO	555 UNIVERSITY AVENUE	TORONTO, ONTARIO				CAN	Cardiovascular Diseases Research	000	3	6/30/2013	EXTENSION WITH OR WITHOUT FUNDS	$308,364
														Subtotal = $323,911

Issue Date FY: 2012 ( Subtotal = $323,911 )
2012	2012	HOSPITAL FOR SICK CHILDREN, TORONTO	555 UNIVERSITY AVENUE	TORONTO, ONTARIO				CAN	Cardiovascular Diseases Research	000	2	6/11/2012	NON-COMPETING CONTINUATION	$323,911
														Subtotal = $323,911

Issue Date FY: 2011 ( Subtotal = $323,911 )
2011	2011	HOSPITAL FOR SICK CHILDREN, TORONTO	555 UNIVERSITY AVENUE	TORONTO, ONTARIO				CAN	Cardiovascular Diseases Research	000	1	7/21/2011	NEW	$323,911
														Subtotal = $323,911

Grand Total All Awards = $1,602,420

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Pediatric Heart Network - The Hospital for Sick Children, Toronto

Award Number: U10HL109777

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2011

PERIOD OF PERFORMANCE END DATE: 12/31/2016

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