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NCT01742936 Clinical Trial

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

Spinal Fusion Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01742936
Other study ID # IRB12-00762
Secondary ID
Status Completed
Phase N/A
First received December 3, 2012
Last updated February 12, 2015
Start date February 2013
Est. completion date January 2015

Study information
Verified date February 2015
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 18 Years
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• CoaguChek

Other:
• Hospital Laboratory

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accuracy of INR on CoaguChek At end of surgery No
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