Point of Care Testing in Pediatric Patients Undergoing Major Surgery

Not Applicable

Completed

• Conditions: Spinal Fusion; Cardiopulmonary Bypass
• Interventions: Device: CoaguChek; Other: Hospital Laboratory

• Registration Number: NCT01742936
• Lead Sponsor: Nationwide Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-03
• Study First Submitted QC: 2012-12-05
• Study First Posted: 2012-12-06
• Study Start: 2013-02
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2016-05-02
• Results First Submitted QC: 2016-05-02
• Results First Posted: 2016-06-08
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spinal fusion	CoaguChek	Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
Cardiac bypass	CoaguChek	Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
Spinal fusion	Hospital Laboratory	Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
Cardiac bypass	Hospital Laboratory	Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.

Primary Outcome Measures

Name	Time	Method
International Normalized Ratio (INR) on CoaguChek	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.
International Normalized Ratio (INR) Performed by Hospital Laboratory	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.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States