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The study is a prospective, non-randomized, non-blinded, non-significant risk study enrolling up to 60 healthy adult subjects consented to undergo a 1-unit whole blood draw procedure. Subjects will wear the study device (CM-1500) while positioned in either a supine or reclined position during the blood draw and study-required physiological parameters will be captured pre-, during, and post-donation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supine Donation Position | Experimental |
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| Reclined Donation Position | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole blood donation supine | Device | Subjects will undergo a 1-unit whole blood donation in a supine position |
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| Measure | Description | Time Frame |
|---|---|---|
| Impact of Subject Positioning on Percent Change of Heart Rate (HR) After Minor Blood Loss (e.g., 500mL) | 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). | Recovery period following donation (10 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra Smith, MD; PhD | SunCoast Blood Centers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitalant Research Institute | Denver | Colorado | 80230 | United States | ||
| SunCoast Blood Centers |
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| ID | Title | Description |
|---|---|---|
| FG000 | Supine Donation Position | Whole blood donation supine: Subjects will undergo a 1-unit whole blood donation in a supine position |
| FG001 | Reclined Donation Position | Whole blood donation reclined: Subjects will undergo a 1-unit whole blood donation in a reclined position |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2025 |
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| Whole blood donation reclined | Device | Subjects will undergo a 1-unit whole blood donation in a reclined position |
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| Bradenton |
| Florida |
| 34211 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Supine Donation Position | Whole blood donation supine: Subjects will undergo a 1-unit whole blood donation in a supine position |
| BG001 | Reclined Donation Position | Whole blood donation reclined: Subjects will undergo a 1-unit whole blood donation in a reclined position |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Impact of Subject Positioning on Percent Change of Heart Rate (HR) After Minor Blood Loss (e.g., 500mL) | 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). | Posted | Mean | Standard Error | percent change | Recovery period following donation (10 minutes) |
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Adverse event data were collected from the point of subject enrollment through a maximum of 24hrs following completion of participations (i.e., 48hrs).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Supine Donation Position | Whole blood donation supine: Subjects will undergo a 1-unit whole blood donation in a supine position | 0 | 60 | 0 | 60 | 0 | 60 |
| EG001 | Reclined Donation Position | Whole blood donation reclined: Subjects will undergo a 1-unit whole blood donation in a reclined position | 0 | 60 | 0 | 60 | 1 | 60 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Yes - Procedure Related | General disorders | Non-systematic Assessment | Subject became dizzy after post-procedure monitoring. Subject was provided juice and a salty snack and was fine upon discharge. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ZMS Clinical | Zynex Monitoring Solutions | 888-386-4185 | clinical@zynex.com |
| Apr 30, 2025 |
| Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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