CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
CoaguChek +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01742936
NCT01742936N/ACompleted

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

Nationwide Children's Hospital·interventional·Posted Dec 6, 2012·Updated Aug 25, 2016

In Brief

A clinical study evaluating CoaguChek and Hospital Laboratory for Spinal Fusion and Cardiopulmonary Bypass. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 6, 2012
Enrollment StartFeb 1, 2013
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 13.6 years ago

Interventions

CoaguChekdevice

Hand held coagulation monitor.

Hospital Laboratoryother

Coagulation testing done by hospital laboratory.