Blood Donors, Traumatic Blood LossNCT02944851
Comparison of the Accuracy of Non-invasive Hemoglobin Measurement (SpHb) and Vena Cava Inferior Ultrasound
An observational study of Blood Donors, Traumatic Blood Loss, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this work is determine the more successful noninvasive method by comparison of two noninvasive methods ( IVC ultrasound - noninvasive hemoglobin measurement (SpHb)) that used in the detection of patients with blood loss. The works were completed in 6 months. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Donors, Traumatic Blood Loss
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2016to Sep 2016
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Voluntary donors for blood donation.
Who may be able to join
- Who have volunteered to donate blood
- Older than 18 years
- Both sexes
Who cannot join
- Known tricuspid valve regurgitation and right heart failure
- Oral intake or the fluid loss (diarrhea and vomiting-urination) between the two measurements during the blood donation
- Inappropriate echogenicity for vena cava inferior diameter measurement
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Reseurch Hospital
Istanbul, 34096
About this study
Official title: Comparison of Noninvasive Two Methods to Monitoring Blood Loss; Inferior Vena Cava (IVC) Ultrasound - Non-invasive Hemoglobin Measurement (SpHb)
The aim of this work is determine the more successful noninvasive method by comparison of two noninvasive methods ( IVC ultrasound - noninvasive hemoglobin measurement (SpHb)) that used in the detection of patients with blood loss.
The works were completed in 6 months. The study was conducted at the blood donation center and in Emergency department. Vital parameters were measured and recorded before making the voluntary blood donation. Following Masimo brand portable device fingers SpHb value was measured.Then IVC diameter of patients in the supine position were measured using ultrasonography. Then he left to donors return in routine blood donation programme. A unit (500ml) of blood were drawn from each donor. After the blood donation process measured and recorded the vital signs again. SpHb was measured noninvasively from finger again. Following these measurements were recorded again by measuring the diameter of IVC.
- Conditions
- Blood Donors, Traumatic Blood Loss
- Keywords
- Blood donors, blood donation, traumatic blood loss, Trauma
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective observational | The changes of IVC diameter, SpHb and vital signs of blood donors were observed after blood donation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of stage 1 hemorrhagic shock
Changes in IVC diameter were observed with 500 ml blood loss. Measurement were made pre and post blood donation.
Measured: 30 minute (15 minute blood donation, 15 minute rest time ).
Diagnosis of stage 1 hemorrhagic shock
Changes in SpHb were observed with 500 ml blood loss. Measurement were made pre and post blood donation.
Measured: 30 minute (15 minute blood donation, 15 minute rest time ).
Secondary outcomes (2)
Diagnosis of stage 1 hemorrhagic shock
Changes in Pulse rate were observed with 500 ml blood loss. Measurement were made pre and post blood donation.
Measured: 30 minute (15 minute blood donation, 15 minute rest time ).
Diagnosis of stage 1 hemorrhagic shock
Changes in Arterial blood pressure were observed with 500 ml blood loss. Measurement were made pre and post blood donation.
Measured: 30 minute (15 minute blood donation, 15 minute rest time ).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Donors, Traumatic Blood LossStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan Yamanoğlu, Haseki Training and Research Hospital
- Investigators
- Adnan Yamanoğlu, MD, Study director, The health ministry, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944851
- Sponsor's protocol ID
- 336
- Status last verified
- May 2018
- First submitted
- 26 Sep 2016
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Noninvasive Two Methods to Monitoring Blood Loss; Inferior Vena Cava (IVC) Ultrasound - Non-invasive Hemoglobin Measurement (SpHb)
- ClinicalTrials.gov ID
- NCT02944851
- Acronym / sponsor ID
- 336
- Conditions
- Blood Donors, Traumatic Blood Loss
- Keywords
- Blood donors, blood donation, traumatic blood loss, Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 26 Oct 2016 (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.
The aim of this work is determine the more successful noninvasive method by comparison of two noninvasive methods ( IVC ultrasound - noninvasive hemoglobin measurement (SpHb)) that used in the detection of patients with blood loss.
The works were completed in 6 months. The study was conducted at the blood donation center and in Emergency department. Vital parameters were measured and recorded before making the voluntary blood donation. Following Masimo brand portable device fingers SpHb value was measured.Then IVC diameter of patients in the supine position were measured using ultrasonography. Then he left to donors return in routine blood donation programme. A unit (500ml) of blood were drawn from each donor. After the blood donation process measured and recorded the vital signs again. SpHb was measured noninvasively from finger again. Following these measurements were recorded again by measuring the diameter of IVC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective observational | – | –The changes of IVC diameter, SpHb and vital signs of blood donors were observed after blood donation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Voluntary donors for blood donation.
Key inclusion criteria (3 listed)
- Who have volunteered to donate blood
- Older than 18 years
- Both sexes
Key exclusion criteria (3 listed)
- Known tricuspid valve regurgitation and right heart failure
- Oral intake or the fluid loss (diarrhea and vomiting-urination) between the two measurements during the blood donation
- Inappropriate echogenicity for vena cava inferior diameter measurement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of stage 1 hemorrhagic shock
Time frame: 30 minute (15 minute blood donation, 15 minute rest time ).
Changes in IVC diameter were observed with 500 ml blood loss. Measurement were made pre and post blood donation.
Diagnosis of stage 1 hemorrhagic shock
Time frame: 30 minute (15 minute blood donation, 15 minute rest time ).
Changes in SpHb were observed with 500 ml blood loss. Measurement were made pre and post blood donation.
2 secondary outcomes
Diagnosis of stage 1 hemorrhagic shock
Time frame: 30 minute (15 minute blood donation, 15 minute rest time ).
Diagnosis of stage 1 hemorrhagic shock
Time frame: 30 minute (15 minute blood donation, 15 minute rest time ).
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 16 May 2018.
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.
Adnan Yamanoğlu, MD study director
The health ministry, Haseki Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Donors, Traumatic Blood Loss, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 16 May 2018. 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 Turkey (Türkiye). 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?
Diagnosis of stage 1 hemorrhagic shock (time frame: 30 minute (15 minute blood donation, 15 minute rest time ).). The study lists 2 primary outcomes in all. 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 16 May 2018.