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Device Monitoring During Blood Donation for Blood Loss

N/A

Recruiting

Led By Debra Smith, MD; PhD

Research Sponsored by Zynex Monitoring Solutions

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Consented and eligible to undergo a single unit whole blood donation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at completion of blood draw

Awards & highlights

Study Summary

This trial will study the safety of a device worn by healthy adults during a routine blood draw. Physiological parameters will be monitored before, during, and after the procedure.

Who is the study for?

This trial is for healthy adults over 18 who can consent to participate and follow the study's procedures. They must be eligible for a single unit whole blood donation but cannot join if they are pregnant, breastfeeding, have a pacemaker, excessive body hair interfering with device sensors, dextrocardia (heart on right side), or missing an upper limb.Check my eligibility

What is being tested?

The study tests how well the CM-1500 device tracks physiological changes and blood loss when subjects donate blood while lying down flat (supine) or at an angle (reclined). It measures various health parameters before, during, and after donating blood.See study design

What are the potential side effects?

Since this trial involves standard whole blood donation procedures, potential side effects include light-headedness, fainting due to low blood pressure from fluid loss, bruising where the needle was inserted, and mild fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I am eligible and have agreed to donate a unit of blood.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at completion of blood draw

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at completion of blood draw

This trial's timeline: 3 weeks for screening, Varies for treatment, and at completion of blood draw for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Impact of subject positioning on percent change of physiological parameters during minor blood loss

Trial Design

2Treatment groups

Experimental Treatment

Group I: Supine Donation PositionExperimental Treatment1 Intervention

Group II: Reclined Donation PositionExperimental Treatment1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Zynex Monitoring SolutionsLead Sponsor

8 Previous Clinical Trials

741 Total Patients Enrolled

Debra Smith, MD; PhDPrincipal InvestigatorSunCoast Blood Centers

Media Library

Supine Donation Position Clinical Trial Eligibility Overview. Trial Name: NCT05980013 — N/A

Dehydration Research Study Groups: Supine Donation Position, Reclined Donation Position

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation currently have room for new participants?

"As indicated on clinicaltrials.gov, this trial is not presently recruiting patients, having been first published on August 28th 2023 and last updated two weeks later. Despite the fact that recruitment for this particular study has concluded, there are 357 other studies actively seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the CM-1500

2023. "Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the CM-1500". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05980013.