N/A N=100 Diagnostic

Point of Care Testing in Pediatric Patients Undergoing Major Surgery

Spinal Fusion · Cardiopulmonary Bypass

Bottom Line

View on ClinicalTrials.gov: NCT01742936 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Jun 2016

Primary outcome: Primary: International Normalized Ratio (INR) on CoaguChek — 1.11; 4.6 ratio

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CoaguChek (Device); Hospital Laboratory (Other)
Age: Pediatric, Adult · 2+ yrs
Sex: All
Sponsor: Nationwide Children's Hospital
Primary completion: Jan 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY International Normalized Ratio (INR) on CoaguChek	1.11; 4.6	—
PRIMARY International Normalized Ratio (INR) Performed by Hospital Laboratory	1.2; 3.5	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01742936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.