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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Vidya Raman, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01742936
First received: December 3, 2012
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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 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.


Condition Intervention
Spinal Fusion
Device: CoaguChek
Other: Hospital Laboratory

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Accuracy of INR on CoaguChek [ Time Frame: At end of surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Spinal fusion
All patients will have testing run on the CoaguChek and in the Hospital Laboratory.
Device: CoaguChek Other: Hospital Laboratory

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742936

Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
  More Information

No publications provided

Responsible Party: Vidya Raman, Director of Preoperative Assessment Testing, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01742936     History of Changes
Other Study ID Numbers: IRB12-00762
Study First Received: December 3, 2012
Last Updated: July 31, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 16, 2014