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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal fusion | Experimental | Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory. |
|
| Cardiac bypass | Experimental | Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoaguChek | Device | Hand held coagulation monitor. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| International Normalized Ratio (INR) on CoaguChek | Measuring the blood's ability to clot on a handheld monitor. | At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion) |
| International Normalized Ratio (INR) Performed by Hospital Laboratory | Measuring the bloods ability to clot by the hospital's reference laboratory. | At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Spinal Fusion | Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory. CoaguChek Hospital Laboratory |
| FG001 | Cardiac Bypass | Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Cardiac Bypass |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | International Normalized Ratio (INR) on CoaguChek | Measuring the blood's ability to clot on a handheld monitor. | Posted | Mean | Standard Deviation | ratio | At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spinal Fusion | Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory. CoaguChek Hospital Laboratory |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vidya Raman, MD | Nationwide Children's Hospital | 614-722-4200 | Vidya.Raman@nationwidechildrens.org |
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| ID | Term |
|---|---|
| D007755 | Laboratories, Hospital |
| ID | Term |
|---|---|
| D006748 | Hospital Departments |
| D006739 | Hospital Administration |
| D058016 | Health Facility Administration |
| D006268 | Health Facilities |
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| Hospital Laboratory |
| Other |
Coagulation testing done by hospital laboratory. |
|
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | International Normalized Ratio (INR) Performed by Hospital Laboratory | Measuring the bloods ability to clot by the hospital's reference laboratory. | 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. | Posted | Mean | Standard Deviation | ratio | At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion) |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Cardiac Bypass | Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory. | 0 | 50 | 0 | 50 |
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| D005159 | Health Care Facilities Workforce and Services |
| D007753 | Laboratories |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |