Determine Validity of Concept of Using Hemoglobin Dilution to Assess/Measure Blood Volume.NCT01900769
Calculating Blood Volume by Dilution of Hemoglobin - Pilot Study
A study testing Blood Volume Dilution in people with Determine Validity of Concept of Using Hemoglobin Dilution to Assess/Measure Blood Volume., run by Kai Schoenhage at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Determine Validity of Concept of Using Hemoglobin Dilution to Assess/Measure Blood Volume.
- What is being tested?
- Blood Volume Dilution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adults of normal constitution (weight/height)
Who cannot join
- any ongoing or recent infusions (< 24h ago) of any fluid/substance
- morbid obesity
- heart disease
- hypertension
- coagulopathy (bleeding disorder)
- therapy with anti- or procoagulants
Show all 17Show fewer
- transfusion of any blood product
- therapy with diuretics
- therapy with vasopressors
- vasodilators or inotropes
- acute or chronic infections
- immunocompromised status
- hemodynamically unstable
- hemorrhage (bleeding)
- recent surgery
- pregnancy
- younger than 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Medical Center
Tucson, Arizona, 85724
About this study
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.
Read more
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.
- Conditions
- Determine Validity of Concept of Using Hemoglobin Dilution to Assess/Measure Blood Volume.
- Being tested
- Blood Volume Dilution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Volume DilutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Blood Volume Dilution | Experimental | Not described Receives: Drug: Blood Volume Dilution |
What is being measured
The primary outcome is the main question the study is designed to answer.
matching BV by Hemoglobin dilution (lab)
Measured: 5 - 40 minutes
Secondary outcomes (1)
matching BV by Hemoglobin dilution (SpHb)
Measured: 5 - 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Determine Validity of Concept of Using Hemoglobin Dilution to Assess/Measure Blood Volume.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kai Schoenhage
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kai Schoenhage, University of Arizona
- Investigators
- Kai Schoenhage, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900769
- Sponsor's protocol ID
- 13-0077
- Status last verified
- Feb 2014
- First submitted
- 12 Jul 2013
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calculating Blood Volume by Dilution of Hemoglobin - Pilot Study
- ClinicalTrials.gov ID
- NCT01900769
- Acronym / sponsor ID
- 13-0077
- Conditions
- Determine Validity of Concept of Using Hemoglobin Dilution to Assess/Measure Blood Volume.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kai SchoenhageUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood Volume Dilution | Experimental | Drug: Blood Volume Dilution |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy adults of normal constitution (weight/height)
Key exclusion criteria (17 listed)
- any ongoing or recent infusions (< 24h ago) of any fluid/substance
- morbid obesity
- heart disease
- hypertension
- coagulopathy (bleeding disorder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Volume Dilution | Drug | Blood Volume Dilution |
Primary outcome
matching BV by Hemoglobin dilution (lab)
Time frame: 5 - 40 minutes
1 secondary outcome
matching BV by Hemoglobin dilution (SpHb)
Time frame: 5 - 40 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai Schoenhage, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Volume Dilution in people with Determine Validity of Concept of Using Hemoglobin Dilution to Assess/Measure Blood Volume., run by Kai Schoenhage at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
matching BV by Hemoglobin dilution (lab) (time frame: 5 - 40 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.