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Peri-operative Assessment of Coagulopathy in Neonates and Infants Undergoing Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02352662
Recruitment Status : Withdrawn (Competition with another study.)
First Posted : February 2, 2015
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
David Faraoni, Boston Children’s Hospital

Brief Summary:
This prospective study will aim to globally assess the coagulopathy induced during cardiac surgery with cardiopulmonary bypass (CPB) in a large pediatric population. The investigators primary objective will be the understanding of CPB-induced coagulopathy based on demographic and surgical characteristics, and coagulation assays. Secondary objective will aim at determining the relationship between coagulation assays, postoperative blood loss, and transfusion requirements. The ultimate goal will be to design an algorithm using point-of-care monitoring that could be used to guide hemostatic therapies in neonates and children undergoing cardiac surgery.To do this, investigators will examine the coagulation in the laboratory based setting.

Condition or disease Intervention/treatment
Congenital Heart Disease Other: Perioperative blood samples collection

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Peri-operative Assessment of Coagulopathy in Neonates and Infants Undergoing Cardiac Surgery
Actual Study Start Date : April 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Study Group
Three blood samples will be collected intra-operatively from each subject enrolled
Other: Perioperative blood samples collection
Collect blood samples at 3 different points intra-operatively. Each blood sample will be run using rotational thromboelastometry to assess intraoperative coagulation




Primary Outcome Measures :
  1. Evidence of CPB-induced coagulopathy confirmed by coagulation assays [ Time Frame: Over 6 months ]

Biospecimen Retention:   Samples Without DNA
Collect bloods samples at three different time points intraoperatively to look at coagulation factors


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neonates and infants undergoing cardiac surgery with cardiopulmonary bypass
Criteria

Inclusion Criteria:

  • Neonates weighing greater than 2.5 kg
  • Patients equal to or less than 12 months of age
  • Undergoing elective cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

  • Emergent procedure
  • The patient is deemed to be in a moribund condition (American Society of Anesthesiology (ASA 5))

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352662


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: David Faraoni, MD Boston Children’s Hospital
Publications:

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Responsible Party: David Faraoni, Cardiac Anesthesiologist, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02352662    
Other Study ID Numbers: IRB-P00016002
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017
Keywords provided by David Faraoni, Boston Children’s Hospital:
Congenital Heart Disease
Point-of-care coagulation monitoring
Rotaional Thromboelastometry
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases