Point of Care Testing in Pediatric Patients Undergoing Major Surgery

Nationwide Children's Hospital100 enrolled

Overview

The current study proposes to investigate Point of Care Testing (POCT) (Coagcheck®) and compare obtained results versus standard laboratory coagulation parameters prothrombin time (PT) and partial thromboplastin time (PTT). The time difference in obtaining the two results will also be examined. A total of 100 pediatric patients undergoing spinal surgery or cardiopulmonary bypass will be enrolled and consented per protocol. Blood samples will be obtained simultaneously tested on both the standard laboratory apparatus and the Coagcheck® device. If the two results are comparable, this could have immediate clinical application and impact in the operating room as POCT results are available within 2-3 minutes compared to 1-2 hours for standard laboratory samples.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Spinal Fusion Cardiopulmonary Bypass

Interventions

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Undergoing elective posterior spinal fusion surgery at Nationwide Children's Hospital * Parents willing \& able to provide informed consent * Child able to provide assent (if age appropriate) Exclusion Criteria: * Pre-existing bleeding disorders * Any other circumstance which, in the opinion of the investigator, would put the patient at increased risk.

Outcomes

Primary Outcomes

International Normalized Ratio (INR) on CoaguChek

Measuring the blood's ability to clot on a handheld monitor.

Time frame: At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion)

International Normalized Ratio (INR) Performed by Hospital Laboratory

Measuring the bloods ability to clot by the hospital's reference laboratory.