Point of Care Testing in Pediatric Patients Undergoing Major Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Point of Care Testing for Coagulation Function Versus Standard Laboratory Testing in Pediatric Patients Undergoing Major Surgery

Conditions
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Spinal Fusion, Cardiopulmonary Bypass

Intervention / Treatment
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* Device: CoaguChek
* Other: Hospital Laboratory


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal fusion<br>Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory. | Device: CoaguChek<br>* Hand held coagulation monitor.<br>Other: Hospital Laboratory<br>* Coagulation testing done by hospital laboratory.<br>|
| Experimental: Cardiac bypass<br>Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory. | Device: CoaguChek<br>* Hand held coagulation monitor.<br>Other: Hospital Laboratory<br>* Coagulation testing done by hospital laboratory.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Normalized Ratio (INR) on CoaguChek | Measuring the blood's ability to clot on a handheld monitor. | 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. | At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion) |