N/A
Completed N=100
Point of Care Testing in Pediatric Patients Undergoing Major Surgery
Spinal Fusion · cardiopulmonary bypass
Source: ClinicalTrials.gov NCT01742936 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: International Normalized Ratio (INR) on CoaguChek — 1.11; 4.6 ratio
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.
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 | — |
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.
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. Informational only — not medical advice.