Coagulation and Fibrinolysis in Pediatric Insulin Titration Trial (CAF-PINT)



Status:Recruiting
Conditions:Cardiology, Pulmonary
Therapuetic Areas:Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any - 18
Updated:4/21/2016
Start Date:October 2012
End Date:October 2016
Contact:Anil Sapru, MD, MAS
Email:saprua@peds.ucsf.edu
Phone:415 476 0963

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Coagulation and Fibrinolysis in a Pediatric Insulin Titration Trial

Project Summary We propose an ancillary study to The Heart and Lung Failure Pediatric
Insulin Titration trial (HALF PINT), which is investigating the impact of normalizing blood
glucose using insulin infusions on clinical outcomes among children with hyperglycemia and
heart and lung failure. In this ancillary study, we will measure plasma levels of
inflammatory, coagulation, and fibrinolysis proteins and genotype DNA for polymorphisms
among patients enrolled in the HALF PINT trial. The results from this ancillary study will
help us to understand potential mechanisms through which normalizing blood glucose provides
benefit, which may lead to development of new therapeutic strategies in critically ill
children

ABSTRACT Hyperglycemia occurs frequently among critically ill children and is associated
with increased morbidity and mortality. Approximately 25% of critically ill children with
heart and lung failure (i.e., those receiving mechanical ventilation and/or inotropes)
develop hyperglycemia within 24 hours of admission, and if the hyperglycemia is sustained
(lasting for > 50% of PICU stay), it results in a 6-fold increase in the odds of mortality.
Previous studies have demonstrated that tight glycemic control with insulin, aimed at
achieving normoglycemia (TGC-NL) can result in improvement in mortality and morbidity in
selected groups of critically ill patients with hyperglycemia. However, the precise
mechanism by which TGC-NL leads to improvement in morbidity and mortality is not known.
Hyperglycemia is known to result in a pro-thrombotic state via activation of coagulation and
impairment of fibrinolysis. This pro-thrombotic, anti-fibrinolytic state, may lead to
intravascular fibrin deposition and micro thrombi, which can be a key contributor to the
pathogenesis of multi-organ failure. We propose to take advantage of The Heart and Lung
Failure Pediatric Insulin Titration trial (HALF PINT) - an NHLBI-funded randomized,
controlled trial designed to study the impact of TGC-NL on clinical outcomes among children
with heart and lung failure - to investigate the effect of TGC-NL on inflammation,
fibrinolysis, and coagulation and to determine the extent to which improvement in deranged
coagulation and fibrinolysis by TGC-NL contributes to improvement in clinical outcomes. We
propose to enroll 800 critically ill patients with hyperglycemia and heart and lung failure
from the HALF PINT study. Since the parent trial will not collect any blood samples other
than for confirmation of blood glucose, we will approach parents or surrogates of children
enrolled in the HALF PINT trial and obtain informed consent for participation in this
ancillary study. We will collect blood samples (3cc from children 2 years and younger, and
5ml from children 3 years and older) at Days 1, 3, and 5 after randomization. We will
measure plasma levels of selected markers of coagulation and fibrinolysis and genotype DNA
for polymorphisms in the corresponding genes. We will correlate changes over time in the
biomarkers with allocation to treatment arm to test whether the beneficial effects of TGC-NL
are achieved via normalization of coagulation and fibrinolysis. We will also genotype for
tag SNPs in the corresponding genes and test for association of the plasma and genetic
markers with clinical outcomes. The results from this study will provide mechanistic
insights into the effect of TGC-NL on clinical outcome and could lead to the use of
anti-inflammatory, anti-coagulant or pro-fibrinolytic agents as adjunctive therapies among
select groups of critically ill children with hyperglycemia who may not be amenable to tight
glucose control or are at higher risk of adverse clinical outcomes from a pro thrombotic
environment. Results from this study may lead to identification of protein or genetic
markers that will identify critically ill children most likely to benefit from existing
anticoagulant therapies such as activated protein C.

Inclusion Criteria:

All Patients enrolled in the HALF PINT trial

Exclusion Criteria:

Bleeding Diathesis as manifest by a Most Recent recorded International Normalized ratio
(INR) >3
We found this trial at
25
sites
Aurora, Colorado 84005
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Ranjit Chima, MD
Phone: 516-636-4267
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Christopher Newth, MD
Phone: 323-361-2117
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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747 52nd St
Oakland, California 94609
(510) 428-3000
Principal Investigator: Heidi Flori, MD
Phone: 510-428-3302
Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
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Oakland, CA
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Principal Investigator: Adam J Schwarz, MD
Phone: 714-509-8620
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Orange, CA
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Vijay Srinivasan, MD
Phone: 215-590-5505
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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100 N Mario Capecchi Dr
Salt Lake City, Utah 84132
(801) 662-1000
Principal Investigator: Ellie L Hirshberg, MD
Phone: 801-581-2897
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Ann Arbor, Michigan 48109
Principal Investigator: Michael Quasney, MD
Phone: 734-764-5302
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Atlanta, Georgia 30322
Principal Investigator: Nga Pham, MD
Phone: 404-785-1606
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Boston, Massachusetts 02115
Principal Investigator: Michael Agus, MD
Phone: 617-355-6000
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Buffalo, New York 14222
Principal Investigator: Amanda Hassinger, MD
Phone: 716-878-1859
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Buffalo, NY
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Principal Investigator: Lauren Marsillio, MD
Phone: 312-227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Chicago, IL
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Chicago, Illinois 60637
Principal Investigator: Neethi Pinto, MD
Phone: 773-702-9659
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7777 Forest Lane
Dallas, Texas 75230
Principal Investigator: Kris Bysani, MD
Phone: 972-566-8340
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Principal Investigator: Peter Luckett, MD
Phone: 214-456-7000
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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Hershey, Pennsylvania 17036
Principal Investigator: Neal J Thomas, MD
Phone: 717-531-8378
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Indianapolis, IN
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Los Angeles, California 90095
Principal Investigator: Myke Federman, MD
Phone: 310-825-0867
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Louisville, Kentucky 40202
Principal Investigator: Kupper A Wintergerst, MD
Phone: 502-588-3400
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Louisville, KY
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Manchester, New Hampshire 03104
Principal Investigator: Sholeen Nett, MD
Phone: 603-650-5599
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New Haven, Connecticut 06511
Principal Investigator: Edward V Faustino, MD
Phone: 203-785-4651
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New Hyde Park, New York 11743
Principal Investigator: James B Schneider, MD
Phone: 718-470-3010
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St. Louis, Missouri 63108
Principal Investigator: John Lin, MD
Phone: 314-454-2527
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Valhalla, New York 10595
Principal Investigator: Simon Li, MD
Phone: 914-493-5634
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