Point of Care Testing in Pediatric Patients Undergoing Major Surgery

Completed · Not applicable

Conditions studied: Spinal Fusion, Cardiopulmonary Bypass

In brief

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.

Key facts

Study ID

NCT01742936

Run by

Nationwide Children's Hospital

People needed

100

Starts

2013-02-01

Expected to finish

2015-01-01

Last updated by the study team

2016-08-25

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Pre-existing bleeding disorders
• Any other circumstance which, in the opinion of the investigator, would put the patient at increased risk.

Where it is running

• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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