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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02352662
Enrollment
0
Registered
2015-02-02
Start date
2015-04-30
Completion date
2017-04-30
Last updated
2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Keywords

Congenital Heart Disease, Point-of-care coagulation monitoring, Rotaional Thromboelastometry

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.

Interventions

OTHERPerioperative 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

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No

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))

Design outcomes

Primary

MeasureTime frame
Evidence of CPB-induced coagulopathy confirmed by coagulation assaysOver 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026