Point of Care Testing in Pediatric Patients Undergoing Major Surgery

Nationwide Children's Hospital

Status: Completed

Conditions: Cardiopulmonary Bypass; Spinal Fusion

Treatments: Other: Hospital Laboratory; Device: CoaguChek

Study type: Interventional

Funder types: Other

Identifiers

NCT01742936

IRB12-00762

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Spinal fusion

Experimental group

Description:

Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.

Treatment:

Other: Hospital Laboratory

Device: CoaguChek

Cardiac bypass

Experimental group

Description:

Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.

Treatment:

Other: Hospital Laboratory

Device: CoaguChek