Trial Outcomes & Findings for Point of Care Testing in Pediatric Patients Undergoing Major Surgery (NCT NCT01742936)
NCT ID: NCT01742936
Last Updated: 2016-08-25
Results Overview
Measuring the blood's ability to clot on a handheld monitor.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion)
Results posted on
2016-08-25
Participant Flow
Participant milestones
| Measure |
Spinal Fusion
Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
CoaguChek
Hospital Laboratory
|
Cardiac Bypass
Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Point of Care Testing in Pediatric Patients Undergoing Major Surgery
Baseline characteristics by cohort
| Measure |
Spinal Fusion
n=50 Participants
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.
|
Cardiac Bypass
n=50 Participants
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.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.1 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
9.4 years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
12 years
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Spinal Fusion
n=49 Participants
Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
CoaguChek
Hospital Laboratory
|
Cardiac Bypass
n=38 Participants
Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
|
|---|---|---|
|
International Normalized Ratio (INR) on CoaguChek
|
1.11 ratio
Standard Deviation 0.07
|
4.6 ratio
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: 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.
Measuring the bloods ability to clot by the hospital's reference laboratory.
Outcome measures
| Measure |
Spinal Fusion
n=49 Participants
Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
CoaguChek
Hospital Laboratory
|
Cardiac Bypass
n=38 Participants
Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
|
|---|---|---|
|
International Normalized Ratio (INR) Performed by Hospital Laboratory
|
1.2 ratio
Standard Deviation 0.1
|
3.5 ratio
Standard Deviation 3.2
|
Adverse Events
Spinal Fusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cardiac Bypass
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place