Trial Outcomes & Findings for Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage (NCT NCT01709786)

Results Overview

Whenever blood was drawn for laboratory measurement of serum hemoglobin, we used one drop of blood to make point-of-care measurements using the CDC and Radical-7 methods. For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table.

Recruitment status

COMPLETED

Target enrollment

88 participants

Primary outcome timeframe

n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.

Results posted on

2016-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With Suspected Hemorrhage There is a single group of patients in this study -- those with suspected hemorrhage who satisfy the inclusion and exclusion criteria. The same set of measurements will be take from each patients and those measurements will be compared with one another to determine accuracy.
Overall Study STARTED	88
Overall Study COMPLETED	88
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Suspected Hemorrhage n=88 Participants There is a single group of patients in this study -- those with suspected hemorrhage who satisfy the inclusion and exclusion criteria. The same set of measurements will be take from each patients and those measurements will be compared with one another to determine accuracy.
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	69 Participants n=39 Participants
Age, Categorical >=65 years	19 Participants n=39 Participants
Sex: Female, Male Female	35 Participants n=39 Participants
Sex: Female, Male Male	53 Participants n=39 Participants

PRIMARY outcome

Timeframe: n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.

Whenever blood was drawn for laboratory measurement of serum hemoglobin, we used one drop of blood to make point-of-care measurements using the CDC and Radical-7 methods. For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table.

Outcome measures

Outcome measures
Measure	Radical-7 Hemoglobin n=88 Participants Radical-7 hemoglobin measurement	CBC Hemoglobin n=88 Participants CBC hemoglobin measurement
CBC Hemoglobin Measurement Compared to Non-invasive Radical-7 Measurement	10.7 grams per deciliter Interval 10.6 to 10.9	9.2 grams per deciliter Interval 9.0 to 9.3

PRIMARY outcome

Timeframe: n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.

When blood was drawn for laboratory measurement of serum hemoglobin, one drop of blood was used to make point of care measurements using the CBC and iSTAT methods. For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table.

Outcome measures

Outcome measures
Measure	Radical-7 Hemoglobin n=88 Participants Radical-7 hemoglobin measurement	CBC Hemoglobin n=88 Participants CBC hemoglobin measurement
CBC Hemoglobin Measurement Compared to Non-invasive iSTAT Measurement	8.5 grams per deciliter Interval 8.4 to 8.7	9.2 grams per deciliter Interval 9.0 to 9.3

Adverse Events

Radical-7 vs. CBC

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

Betty Tsuei, MD

University of Cincinnati

Phone: 513-558-5661

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place