Impact of SpHb Monitoring on Transfusion

Anemia Clinical Trial

Official title:

Continuous and Noninvasive Hemoglobin Monitoring Reduces Red Blood Cell Transfusion During Neurosurgery: A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01906515
• Other study ID #: doctor19
• Status: Completed
• Phase: N/A
• First received: July 13, 2013
• Last updated: January 24, 2014
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2014
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Continuous and noninvasive hemoglobin (SpHb) monitoring provides clinicians with real-time trending of changes or lack of changes in hemoglobin, which has the potential to alter red blood cell (RBC) transfusion decision making. The objective of this study was to evaluate the impact of SpHb monitoring on RBC transfusions in high blood loss surgery. The investigators hypothesize that SpHb will improve blood transfusion practice in the for of change the number of blood unit per patient and improve the outcome regards the time to take decision of transfusion trigger.

Description:

Eligible patients scheduled for neurosurgeries were enrolled into either a standard care group (Control Group) or an intervention group (SpHb Group). The Control Group received typical anesthesia care including estimated blood loss (EBL) assessment and intraoperative hemoglobin measurements from the central laboratory (Hb). Blood samples were taken when EBL was ≥15% of total blood volume. RBC transfusion was initiated if Hb was ≤10 g/dL and continued until the EBL was replaced and Hb >10g/dL was confirmed. The SpHb Group followed the same transfusion practice as the Control Group except the anesthesiologist was guided by the addition of SpHb monitoring with blood samples still taken pre- and post-transfusion. Additionally, the absolute and trend accuracy of SpHb compared to Hb was evaluated. Potential cost savings from reduced RBC utilization will be calculated if occured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA 1,2 patients from 15 to 60 years old scheduled for neurosurgical procedure

Exclusion Criteria:

• Exclusion criteria included significant liver or renal disease, coagulopathy, pregnancy, anemia, and patients scheduled for procedures with excepted low blood loss.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia

Intervention

Device:
• Continuous non-invasive hemoglobin monitoring
Anesthesiologist is provided with real-time continuous non-invasive hemoglobin monitoring to influence care provided to patient

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Masimo Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Potential Cost Savings	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.	During surgery (an average of about 4 hours)	No
Primary	RBC Transfusions Per Subject Receiving a Transfusion	Determine whether using SpHb can affect the quantity of RBC transfused, per patient receiving a transfusion.	During surgery (an average of about 4 hours)	No
Primary	The Effect of SpHb on Transfusion Timeline	Length of time it takes to initiate a RBC transfusion after the need was first established.	During surgery (an average of about 4 hours)	No
Secondary	SpHb Absolute and Trend Accuracy	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	During surgery (an average of about 4 hours)	Yes