Point of Care Testing in Pediatric Patients Undergoing Major Surgery

NCT01742936 | Completed Results

• 1 other identifier: IRB12-00762
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Fusion; Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (2)

• International Normalized Ratio (INR) on CoaguChek

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

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

• International Normalized Ratio (INR) Performed by Hospital Laboratory

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

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

Study Arms (2)

Spinal fusion

EXPERIMENTAL

Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.

Device: CoaguChek; Other: Hospital Laboratory

Cardiac bypass

EXPERIMENTAL

Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.

Device: CoaguChek; Other: Hospital Laboratory

Interventions

CoaguChek DEVICE

Hand held coagulation monitor.

Cardiac bypass; Spinal fusion

Hospital Laboratory OTHER

Coagulation testing done by hospital laboratory.

Cardiac bypass; Spinal fusion

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Pre-existing bleeding disorders
• Any other circumstance which, in the opinion of the investigator, would put the patient at increased risk.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Laboratories, Hospital

Intervention Hierarchy (Ancestors)

Hospital Departments; Hospital Administration; Health Facility Administration; Health Facilities; Health Care Facilities Workforce and Services; Laboratories; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Vidya Raman, MD
• Organization: Nationwide Children's Hospital

Vidya.Raman@nationwidechildrens.org

614-722-4200

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Preoperative Assessment Testing

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 6, 2012
• Study Start: February 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: August 25, 2016
• Results First Posted: June 8, 2016

Record last verified: 2016-07

Locations

US (1)