Point of Care Testing in Pediatric Patients Undergoing Major Surgery

NCT ID: NCT01742936

Last Updated: 2016-08-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-01-31

Brief Summary

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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

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Conditions

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Spinal Fusion Cardiopulmonary Bypass

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Spinal fusion

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

Group Type EXPERIMENTAL

CoaguChek

Intervention Type DEVICE

Hand held coagulation monitor.

Hospital Laboratory

Intervention Type OTHER

Coagulation testing done by hospital laboratory.

Cardiac bypass

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

Group Type EXPERIMENTAL

CoaguChek

Intervention Type DEVICE

Hand held coagulation monitor.

Hospital Laboratory

Intervention Type OTHER

Coagulation testing done by hospital laboratory.

Interventions

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CoaguChek

Hand held coagulation monitor.

Intervention Type DEVICE

Hospital Laboratory

Coagulation testing done by hospital laboratory.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Vidya Raman

Director of Preoperative Assessment Testing

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB12-00762

Identifier Type: -

Identifier Source: org_study_id

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