Clinical Evaluation of the CM-1500 During Apheresis Blood Donation

Not Applicable

Completed

• Conditions: Fluid Loss

• Registration Number: NCT05012462
• Lead Sponsor: Zynex Monitoring Solutions

Brief Summary

The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 200 healthy adult subjects consented to undergo an apheresis donation procedure. Subjects will be connected to the Zynex Cardiac Monitor, Model 1500 (CM-1500) to characterize changes in the relative index during an apheresis donation procedure.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-08-12
• Study First Posted: 2021-08-19
• Study Start: 2021-09-20
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-20
• Results First Submitted: 2024-06-20
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Results First Posted: 2024-12-06
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Ability to provide written informed consent
• Ability and willingness to comply with the study procedures and duration requirements
• 18 years of age or older
• Consented to undergo an apheresis procedure with an automated blood component device

Exclusion Criteria

• Females who are pregnant or breastfeeding
• Undergone an amputation of the left upper extremity
• Diagnosed with dextrocardia
• Subjects who have a pacemaker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Characterize Changes in the Relative Index During an Apheresis Procedure	Duration of apheresis procedure (e.g., 2 - 3hrs)	The objective of the study is to characterize changes in the Relative Index (RI) as a representation of its associated parameters during apheresis. This was measured by averaging the RI values after the procedure. Changes in parameters from their baseline can be used as an indicator of potential change in fluid status. This change may be reflected in the RI since it is a summated value (weighted summation of percent change) combining the changes of the parameters into a single value. In the case of fluid loss such as apheresis the RI value may decrease as a result of changes in the parameters which can change in response to fluid status change. The RI is a unitless value with no set min. or max. Within the context of this trial trying to evaluate the RI, a decrease from 100 was considered a good outcome. However, in clinical use, the RI should not be used as an indicator of patient status, instead it could be used to monitor trending of patient parameters relative to their baseline.

Trial Locations

Locations (1)

Vitalant Blood Donation; 🇺🇸 Denver, Colorado, United States