Cardiopulmonary Bypass, Spinal Fusion
Conditions
Brief 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.
Interventions
DEVICECoaguChek
Hand held coagulation monitor.
OTHERHospital Laboratory
Coagulation testing done by hospital laboratory.
Sponsors
Nationwide Children's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Normalized Ratio (INR) on CoaguChek | At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion) | Measuring the blood's ability to clot on a handheld monitor. |
| International Normalized Ratio (INR) Performed by Hospital Laboratory | At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion) | Measuring the bloods ability to clot by the hospital's reference laboratory. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spinal Fusion Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
CoaguChek: Hand held coagulation monitor.
Hospital Laboratory: Coagulation testing done by hospital laboratory. | 50 |
| Cardiac Bypass Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
CoaguChek: Hand held coagulation monitor.
Hospital Laboratory: Coagulation testing done by hospital laboratory. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Spinal Fusion | Cardiac Bypass | Total |
|---|---|---|---|
| Age, Continuous | 14.1 years STANDARD_DEVIATION 2.2 | 9.4 years STANDARD_DEVIATION 4.4 | 12 years STANDARD_DEVIATION 4 |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 33 Participants | 14 Participants | 47 Participants |
| Sex: Female, Male Male | 17 Participants | 36 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
International Normalized Ratio (INR) on CoaguChek
Measuring the blood's ability to clot on a handheld monitor.
Time frame: At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Fusion | International Normalized Ratio (INR) on CoaguChek | 1.11 ratio | Standard Deviation 0.07 |
| Cardiac Bypass | International Normalized Ratio (INR) on CoaguChek | 4.6 ratio | Standard Deviation 2.1 |
Primary
International Normalized Ratio (INR) Performed by Hospital Laboratory
Measuring the bloods ability to clot by the hospital's reference laboratory.
Time frame: At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion)
Population: Three cases of device error with CoaguChek®, 1 insufficient blood for measurement in the laboratory, and 1 communication failure during sending the blood sample to the laboratory occurred leaving 87 patients for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Fusion | International Normalized Ratio (INR) Performed by Hospital Laboratory | 1.2 ratio | Standard Deviation 0.1 |
| Cardiac Bypass | International Normalized Ratio (INR) Performed by Hospital Laboratory | 3.5 ratio | Standard Deviation 3.2 |