NCT01742936

Point of Care Testing in Pediatric Patients Undergoing Major Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Nationwide Children's Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	CoaguChek	Hand held coagulation monitor.
OTHER	Hospital Laboratory	Coagulation testing done by hospital laboratory.

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2012-12-06
• Last updated: 2016-08-25
• Results posted: 2016-06-08

Locations

1 site across 1 country: United States