Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-31 @ 1:51 PM
Study NCT ID:
NCT01900769
Status:
COMPLETED
Last Update Posted:
2014-02-19
First Post:
2013-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calculating Blood Volume by Dilution of Hemoglobin - Pilot Study
Sponsor:
Kai Schoenhage
Organization:
Study Overview
Official Title:
Calculating Blood Volume by Dilution of Hemoglobin - Pilot Study
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although blood volume is such an important parameter in everyday clinical medicine it cannot be measured easily. As a matter of fact, it is almost never measured but estimated or calculated based upon numbers derived from mostly healthy patients.
The investigators do not even know whether someone's normal - i.e. before a surgery - blood volume is actually anywhere close to the generally accepted estimate or calculation.
Tests exist in which a substance of known concentration is diluted in a person's blood volume and the resulting concentration is then measured, which allows the blood volume to be calculated. However, none of these tests can be completed at the bedside since they are not fast and require considerable set-up.
This study turns the above approach upside-down: we will dilute the blood slightly with a known small volume of an intravenous fluid commonly used in many clinical settings and measure the concentra-tion of hemoglobin - the oxygen carrier contained in red blood cells - before and after adding the fluid. That allows for similar calculations without using neither specialized substances nor equipment.
Hemoglobin is routinely measured in laboratories and is often a routine test before and during surg-eries and in intensive care units.
Devices that can measure hemoglobin through the skin without actually drawing any blood are avail-able. If found comparable to laboratory determination of hemoglobin they could provide for a bedside and almost real-time assessment of blood volume, something that could be extremely valuable for de-cision making in critical areas of medicine and promoting goal directed therapies.
The investigators do not even know whether someone's normal - i.e. before a surgery - blood volume is actually anywhere close to the generally accepted estimate or calculation.
Tests exist in which a substance of known concentration is diluted in a person's blood volume and the resulting concentration is then measured, which allows the blood volume to be calculated. However, none of these tests can be completed at the bedside since they are not fast and require considerable set-up.
This study turns the above approach upside-down: we will dilute the blood slightly with a known small volume of an intravenous fluid commonly used in many clinical settings and measure the concentra-tion of hemoglobin - the oxygen carrier contained in red blood cells - before and after adding the fluid. That allows for similar calculations without using neither specialized substances nor equipment.
Hemoglobin is routinely measured in laboratories and is often a routine test before and during surg-eries and in intensive care units.
Devices that can measure hemoglobin through the skin without actually drawing any blood are avail-able. If found comparable to laboratory determination of hemoglobin they could provide for a bedside and almost real-time assessment of blood volume, something that could be extremely valuable for de-cision making in critical areas of medicine and promoting goal directed therapies.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: