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Point of Care Testing in Pediatric Patients Undergoing Major Surgery

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ClinicalTrials.gov Identifier: NCT01742936
Recruitment Status : Completed
First Posted : December 6, 2012
Results First Posted : June 8, 2016
Last Update Posted : August 25, 2016
Sponsor:
Information provided by (Responsible Party):
Vidya Raman, Nationwide Children's Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Fusion Cardiopulmonary Bypass Device: CoaguChek Other: Hospital Laboratory Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Point of Care Testing for Coagulation Function Versus Standard Laboratory Testing in Pediatric Patients Undergoing Major Surgery
Study Start Date : February 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: Spinal fusion
Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
 Device: CoaguChek
Hand held coagulation monitor.

Other: Hospital Laboratory
Coagulation testing done by hospital laboratory.
Experimental: Cardiac bypass
Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
 Device: CoaguChek
Hand held coagulation monitor.

Other: Hospital Laboratory
Coagulation testing done by hospital laboratory.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01742936


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
More Information
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Responsible Party: Vidya Raman, Director of Preoperative Assessment Testing, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01742936    
Other Study ID Numbers: IRB12-00762
First Posted: December 6, 2012    Key Record Dates
Results First Posted: June 8, 2016
Last Update Posted: August 25, 2016
Last Verified: July 2016