Trial Outcomes & Findings for Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the CM-1500 (NCT NCT05980013)

Results Overview

The objective of this study is to determine if manual blood loss of up to 500mL of blood affects heart rate. This will be measured by determining the percent change in HR before and after the Blood Draw. The percent change will be calculated separately for each Arm (reclined, supine). Based on previous studies, a positive outcome would be indicated by an increase in HR (i.e., positive percent change).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

Recovery period following donation (10 minutes)

Results posted on

2025-05-02

Participant Flow

Participant milestones

Participant milestones
Measure	Supine Donation Position Whole blood donation supine: Subjects will undergo a 1-unit whole blood donation in a supine position	Reclined Donation Position Whole blood donation reclined: Subjects will undergo a 1-unit whole blood donation in a reclined position
Overall Study STARTED	60	60
Overall Study COMPLETED	60	58
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Supine Donation Position Whole blood donation supine: Subjects will undergo a 1-unit whole blood donation in a supine position	Reclined Donation Position Whole blood donation reclined: Subjects will undergo a 1-unit whole blood donation in a reclined position
Overall Study Withdrawal by Subject	0	1
Overall Study Device Error	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supine Donation Position n=60 Participants Whole blood donation supine: Subjects will undergo a 1-unit whole blood donation in a supine position	Reclined Donation Position n=60 Participants Whole blood donation reclined: Subjects will undergo a 1-unit whole blood donation in a reclined position	Total n=120 Participants Total of all reporting groups
Age, Continuous	52.2 years STANDARD_DEVIATION 18.8 • n=60 Participants	48.1 years STANDARD_DEVIATION 18.3 • n=60 Participants	50.2 years STANDARD_DEVIATION 18.6 • n=120 Participants
Sex: Female, Male Female	29 Participants n=60 Participants	25 Participants n=60 Participants	54 Participants n=120 Participants
Sex: Female, Male Male	31 Participants n=60 Participants	35 Participants n=60 Participants	66 Participants n=120 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	60 participants n=60 Participants	60 participants n=60 Participants	120 participants n=120 Participants

PRIMARY outcome

Timeframe: Recovery period following donation (10 minutes)

The objective of this study is to determine if manual blood loss of up to 500mL of blood affects heart rate. This will be measured by determining the percent change in HR before and after the Blood Draw. The percent change will be calculated separately for each Arm (reclined, supine). Based on previous studies, a positive outcome would be indicated by an increase in HR (i.e., positive percent change).

Outcome measures

Outcome measures
Measure	Supine Donation Position n=60 Participants Whole blood donation supine: Subjects will undergo a 1-unit whole blood donation in a supine position	Reclined Donation Position n=58 Participants Whole blood donation reclined: Subjects will undergo a 1-unit whole blood donation in a reclined position
Impact of Subject Positioning on Percent Change of Heart Rate (HR) After Minor Blood Loss (e.g., 500mL)	10.7 percent change Standard Error 2.3	14.7 percent change Standard Error 2.4

Adverse Events

Supine Donation Position

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reclined Donation Position

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Supine Donation Position n=60 participants at risk Whole blood donation supine: Subjects will undergo a 1-unit whole blood donation in a supine position	Reclined Donation Position n=60 participants at risk Whole blood donation reclined: Subjects will undergo a 1-unit whole blood donation in a reclined position
General disorders Yes - Procedure Related	0.00% 0/60 • Adverse event data were collected from the point of subject enrollment through a maximum of 24hrs following completion of participations (i.e., 48hrs).	1.7% 1/60 • Number of events 1 • Adverse event data were collected from the point of subject enrollment through a maximum of 24hrs following completion of participations (i.e., 48hrs).

Additional Information

ZMS Clinical

Zynex Monitoring Solutions

Phone: 888-386-4185

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place