Non-invasive Hemodynamic Monitoring During Blood Donation for Developing Models of Early Blood Loss
This study is ongoing, but not recruiting participants.
Sponsor:
University of Colorado, Denver
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01448694
First received: October 5, 2011
Last updated: March 8, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study is part of a Phase II STTR project to develop an algorithm called CipherSensor to apply feature extraction and machine learning techniques to non-invasive hemodynamic data to identify early signs of acute blood loss. The availability of this information may help to establish required interventions for treating trauma patients and battlefield casualties.
Study hypothesis: Hemodynamic changes measured non-invasively during the blood donation process can be modeled to provide early estimations of blood loss.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemorrhage |
Other: No treatment |
Phase 2 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Non-invasive Hemodynamic Monitoring During Blood Donation for Developing Models of Early Blood Loss. |
Further study details as provided by University of Colorado, Denver:
Primary Outcome Measures:
- Algorithm [ Time Frame: 24 months ] [ Designated as safety issue: No ]Mathematical model of early blood loss
| Estimated Enrollment: | 400 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Blood donors
Healthy volunteers who are donating a pint of whole blood
|
Other: No treatment
No treatment, only collecting observational data.
Other Name: No treatment
|
Eligibility| Ages Eligible for Study: | 18 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Healthy adults
Criteria
Inclusion Criteria:
- Approved by Children's Hospital Colorado Blood Donation Center for blood donation
- Age 18 -89 years
- Previously donated blood (lower likelihood of vasovagal response)
Exclusion Criteria:
- Pregnant
- Incarcerated
- Limited access to or compromised monitoring sites for non-invasive sensors: finger, ear and forehead sensors, oral/nasal cannula, 3 ECG electrodes.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448694
Locations
| United States, Colorado | |
| Children's Hospital Colorado | |
| Aurora, Colorado, United States, 80045 | |
Sponsors and Collaborators
University of Colorado, Denver
Investigators
| Principal Investigator: | Steve Moulton, MD | Children's Hospital Colorado |
More Information
No publications provided
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT01448694 History of Changes |
| Other Study ID Numbers: | 10-1421 |
| Study First Received: | October 5, 2011 |
| Last Updated: | March 8, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by University of Colorado, Denver:
|
Hemorrhage |
Additional relevant MeSH terms:
|
Hemorrhage Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013