Trial Outcomes & Findings for Impact of SpHb Monitoring on Transfusion (NCT NCT01906515)
NCT ID: NCT01906515
Last Updated: 2014-02-27
Results Overview
Determine whether using SpHb can affect the quantity of RBC transfused, per patient receiving a transfusion.
COMPLETED
NA
106 participants
During surgery (an average of about 4 hours)
2014-02-27
Participant Flow
Patients scheduled for neurosurgery
Participant milestones
| Measure |
SpHb Group.
In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.
Continuous non invasive hemoglobin monitoring arm
continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry
|
Control Group
Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
61
|
|
Overall Study
COMPLETED
|
45
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of SpHb Monitoring on Transfusion
Baseline characteristics by cohort
| Measure |
SpHb Group.
n=45 Participants
In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.
Continuous non invasive hemoglobin monitoring arm
Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry
|
Control Group
n=61 Participants
Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
Egypt
|
45 participants
n=5 Participants
|
61 participants
n=7 Participants
|
106 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During surgery (an average of about 4 hours)Population: We only included the participants who received a blood transfusion during the surgery for this analysis. Participants who did not receive a transfusion were excluded from this analysis.
Determine whether using SpHb can affect the quantity of RBC transfused, per patient receiving a transfusion.
Outcome measures
| Measure |
SpHb Group.
n=19 Participants
In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.
Continuous non invasive hemoglobin monitoring arm
Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry
|
Control Group
n=30 Participants
Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
|
|---|---|---|
|
RBC Transfusions Per Subject Receiving a Transfusion
|
2.3 units
Interval 1.6 to 3.0
|
3.9 units
Interval 3.2 to 4.5
|
PRIMARY outcome
Timeframe: During surgery (an average of about 4 hours)Population: We only included the participants who received a blood transfusion during the surgery for this analysis. Participants who did not receive a transfusion were excluded from this analysis.
Length of time it takes to initiate a RBC transfusion after the need was first established.
Outcome measures
| Measure |
SpHb Group.
n=19 Participants
In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.
Continuous non invasive hemoglobin monitoring arm
Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry
|
Control Group
n=30 Participants
Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
|
|---|---|---|
|
The Effect of SpHb on Transfusion Timeline
|
9.2 minutes
Interval 8.4 to 10.0
|
50.2 minutes
Interval 47.3 to 53.0
|
SECONDARY outcome
Timeframe: During surgery (an average of about 4 hours)To assess absolute accuracy, or single point comparison, paired SpHb and Hb measurements were compared pre- and post- transfusion and bias and standard deviation were calculated. A Bland Altman graph with limits of agreement (1.96 x standard deviation, adjusted for the bias) was plotted to show agreement across the range of values. To assess trending, a regression plot of changes in Hb and corresponding changes in SpHb was plotted and a coefficient of determination (R2) was calculated
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: During surgery (an average of about 4 hours)Potential cost saving resulting from reduced RBC utilization was estimated using activity-based cost estimates established by Shander et al.(8) which determined from both U.S. and European hospitals the total cost of transfusing one RBC unit to be between $522 and $1,183 with a mean and standard deviation of $761 ± $294.
Outcome measures
Outcome data not reported
Adverse Events
SpHb Group.
Control Group
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