Trial Outcomes & Findings for Validating a New Method to Assess Estimated Blood Loss in the Obstetric Population (NCT NCT03404375)

NCT ID: NCT03404375

Last Updated: 2021-02-25

Results Overview

The investigators are looking at the difference between the EBL measured clinically and the EBL measured using the Gauss device

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 242 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2021-02-25

Participant Flow

Participant milestones

Measure	Cases Cases defined as delta hemoglobin in the upper quartile	Control Controls defined as delta hemoglobin in the lower quartile
Overall Study STARTED	70	172
Overall Study COMPLETED	70	172
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Validating a New Method to Assess Estimated Blood Loss in the Obstetric Population

Baseline characteristics by cohort

Measure	Cases n=70 Participants Cases defined as delta hemoglobin in the upper quartile	Control n=172 Participants Controls defined as delta hemoglobin in the lower quartile	Total n=242 Participants Total of all reporting groups
Age, Continuous	30 years n=5 Participants	29 years n=7 Participants	29 years n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	172 Participants n=7 Participants	242 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=5 Participants	69 Participants n=7 Participants	95 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants	103 Participants n=7 Participants	147 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	70 participants n=5 Participants	172 participants n=7 Participants	242 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

The investigators are looking at the difference between the EBL measured clinically and the EBL measured using the Gauss device

Outcome measures

Measure	Cases n=70 Participants Cases defined as delta hemoglobin in the upper quartile	Control n=172 Participants Controls defined as delta hemoglobin in the lower quartile
Clinical Estimated Blood Loss (EBL) Between Cases and Controls Using Clinical Estimate Versus Device Assessment	800 milliLiters Interval 700.0 to 900.0	800 milliLiters Interval 600.0 to 900.0

PRIMARY outcome

Timeframe: 48 hours

The investigators are looking at the difference between the EBL measured clinically and the EBL measured using the Gauss device (Triton)

Outcome measures

Measure	Cases n=70 Participants Cases defined as delta hemoglobin in the upper quartile	Control n=172 Participants Controls defined as delta hemoglobin in the lower quartile
Triton Device Estimated Blood Loss (EBL) Between Cases and Controls Using Clinical Estimate Versus Device Assessment	474 milliLiters Interval 300.0 to 642.0	331 milliLiters Interval 222.0 to 469.0

SECONDARY outcome

Timeframe: 48 hours

Number of participants that received blood transfusion

Outcome measures

Measure	Cases n=70 Participants Cases defined as delta hemoglobin in the upper quartile	Control n=172 Participants Controls defined as delta hemoglobin in the lower quartile
Transfusion Requirements	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 48 hours

the number of cases of post partum hemorrhage

Outcome measures

Measure	Cases n=70 Participants Cases defined as delta hemoglobin in the upper quartile	Control n=172 Participants Controls defined as delta hemoglobin in the lower quartile
Number of Participants With Post-partum Hemorrhage	8 Participants	11 Participants

Adverse Events

Cases

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cases n=70 participants at risk Cases defined as delta hemoglobin in the upper quartile	Control n=172 participants at risk Controls defined as delta hemoglobin in the lower quartile
Blood and lymphatic system disorders Post Partum Hemorrhage	11.4% 8/70 • Number of events 8 • 9 months	6.4% 11/172 • Number of events 11 • 9 months

Additional Information

Antonio Saad

UTMB Galveston

Phone: 4097721571

Email: afsaad@utmb.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place