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Completed

NCT Number: NCT01742936

Point of Care Testing in Pediatric Patients Undergoing Major Surgery

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.

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Key information

Conditions

Spinal Fusion Cardiopulmonary Bypass

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coaguchek

Device

Hand held coagulation monitor.

Hospital Laboratory

Other

Coagulation testing done by hospital laboratory.

Primary outcomes

  1. International Normalized Ratio (INR) on CoaguChek

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

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

  2. International Normalized Ratio (INR) Performed by Hospital Laboratory

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

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

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 6, 2012
Registry last updated
Aug 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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