AnemiaNCT03586141
Pronto for Patient Blood Management
A study testing Pronto® hemoglobin measurement tool in people with Anemia, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The concept of Patient Blood Management requires preoperative diagnostic of anemia. To avoid the harmful procedure of venous puncture for drawing a blood sample, noninvasive measurement of hemoglobin has been developed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anemia
- What is being tested?
- Pronto® hemoglobin measurement tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,129 participants
- Where
- 1 siteGermany
- Study dates
- 22 Jul 2018to 30 Nov 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults and children >=3kg that are planned to undergo elective surgery
- Written informed consent
Who cannot join
- no written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Hb-measurement of Pronto ® as Screening Tool for Preoperative Diagnostic of Anemia
The concept of Patient Blood Management requires preoperative diagnostic of anemia. To avoid the harmful procedure of venous puncture for drawing a blood sample, noninvasive measurement of hemoglobin has been developed. However noninvasive measurement of hemoglobin has yet been not accurate enough to replace invasive hemoglobin measurement. This study investigates if a noninvasive measurement tool can serve as a screening tool to find out for which patients invasive measurement of hemoglobin is necessary.
Read the detailed description
The noninvasive hemoglobin measurement tool Pronto® can measure hemoglobin noninvasively by a sensor clip. The investigators analyzed previous studies with the Pronto device and calculated two cut-off values of the noninvasive hemoglobin device. If noninvasive hemoglobin values are higher than cut off value 1 the investigators postulate that with a sensitivity of 99% the participant has no anemia. To confirm this, participants who are supposed to undergo elective surgery and come to the preoperative anesthetic ambulance are measured by the Pronto-device. The noninvasive measurements are compared with the laboratory values of the patients and cut-off value 1 can be confirmed.
- Conditions
- Anemia
- Being tested
- Pronto® hemoglobin measurement tool
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pronto® hemoglobin measurement toolDiagnostic test
All patients who are planned to undergo elective surgery come to the preoperative anesthetic ambulance. They are all measured by the Pronto® hemoglobin measurement tool
| Study group | Role | What they receive |
|---|---|---|
| noninvasive measurement of hemoglobin | Other | All participating patients are measured by the Pronto® hemoglobin measurement tool Receives: Diagnostic Test: Pronto® hemoglobin measurement tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of a postulated noninvasively measured haemoglobin value as a cut-off value for the decision wether invasively measuring of haemoglobin concentration for preoperative patient blood management is necessary.
Previous studies show that noninvasively measured haemoglobin is not accurate enough to determine exactly the haemoglobin value for preoperative diagnosis of anaemia. We postulate that noninvasive haemoglobin measurement can be used as a screening tool to decide wether invasive measurement of haemoglobin is necessary. We calculated a cut-off value 1 by analysing previous studies. Noninvasive haemoglobin measurements that are above the cut-off-value are postulated to show that the patient is not anaemic with a sensitivity of 99%.
Measured: five to ten minutes
Secondary outcomes (2)
Validation of postulated non invasively measured haemoglobin value as a cut off-value 2
We calculated a cut-off value 2 by analysing previous studies. Noninvasive haemoglobin measurements that are below the cut-off-value 2 are postulated to show that the patient is anaemic with a speciality of 99%.
Measured: five to ten minutes
Agreement between invasive and noninvasive measurement in adults and children
Noninvasive haemoglobin measurement values are compared with invasive haemoglobin measurement values
Measured: five to ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start22 Jul 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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
- Model description
- measurement of hemoglobin by a noninvasive sensor clip
- Masking
- None (open label)
- Enrolment
- 1,129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Eva Wittenmeier, Johannes Gutenberg University Mainz
- Investigators
- Eva Wittenmeier, MD, Principal investigator, Johannes Gutenberg University Centre, department of anaesthesiology, Langenbeckstraße 1, 55131 Mainz, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586141
- Sponsor's protocol ID
- Pronto for PBM
- Status last verified
- Feb 2019
- First submitted
- 21 Jun 2018
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohnke K, Smetiprach J, Paumen Y, Mildenberger P, Komorek Y, Griemert EV, Wittenmeier E. Is noninvasive hemoglobin measurement suitable for children undergoing preoperative anesthesia consultation? J Clin Monit Comput. 2025 Feb;39(1):175-182. doi: 10.1007/s10877-024-01194-7. Epub 2024 Jul 20.
PubMed 39031232Wittenmeier E, Paumen Y, Mildenberger P, Smetiprach J, Pirlich N, Griemert EV, Kriege M, Engelhard K. Non-invasive haemoglobin measurement as an index test to detect pre-operative anaemia in elective surgery patients - a prospective study. Anaesthesia. 2021 May;76(5):647-654. doi: 10.1111/anae.15312. Epub 2020 Nov 23.
PubMed 33227153
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Hb-measurement of Pronto ® as Screening Tool for Preoperative Diagnostic of Anemia
- ClinicalTrials.gov ID
- NCT03586141
- Acronym / sponsor ID
- Pronto for PBM
- Conditions
- Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,129 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 22 Jul 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 13 Jul 2018 (actual)
- 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 concept of Patient Blood Management requires preoperative diagnostic of anemia. To avoid the harmful procedure of venous puncture for drawing a blood sample, noninvasive measurement of hemoglobin has been developed. However noninvasive measurement of hemoglobin has yet been not accurate enough to replace invasive hemoglobin measurement. This study investigates if a noninvasive measurement tool can serve as a screening tool to find out for which patients invasive measurement of hemoglobin is necessary.
Detailed description
The noninvasive hemoglobin measurement tool Pronto® can measure hemoglobin noninvasively by a sensor clip. The investigators analyzed previous studies with the Pronto device and calculated two cut-off values of the noninvasive hemoglobin device. If noninvasive hemoglobin values are higher than cut off value 1 the investigators postulate that with a sensitivity of 99% the participant has no anemia. To confirm this, participants who are supposed to undergo elective surgery and come to the preoperative anesthetic ambulance are measured by the Pronto-device. The noninvasive measurements are compared with the laboratory values of the patients and cut-off value 1 can be confirmed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- measurement of hemoglobin by a noninvasive sensor clip
| Arm | Type | Receives |
|---|---|---|
| noninvasive measurement of hemoglobin | Other | Diagnostic Test: Pronto® hemoglobin measurement toolAll participating patients are measured by the Pronto® hemoglobin measurement tool |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adults and children >=3kg that are planned to undergo elective surgery
- Written informed consent
Key exclusion criteria (1 listed)
- no written informed consent
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 |
|---|---|---|
| Pronto® hemoglobin measurement toolAll patients who are planned to undergo elective surgery come to the preoperative anesthetic ambulance. They are all measured by the Pronto® hemoglobin measurement tool | Diagnostic test | noninvasive measurement of hemoglobin |
Primary outcome
Validation of a postulated noninvasively measured haemoglobin value as a cut-off value for the decision wether invasively measuring of haemoglobin concentration for preoperative patient blood management is necessary.
Time frame: five to ten minutes
Previous studies show that noninvasively measured haemoglobin is not accurate enough to determine exactly the haemoglobin value for preoperative diagnosis of anaemia. We postulate that noninvasive haemoglobin measurement can be used as a screening tool to decide wether invasive measurement of haemoglobin is necessary. We calculated a cut-off value 1 by analysing previous studies. Noninvasive haemoglobin measurements that are above the cut-off-value are postulated to show that the patient is not anaemic with a sensitivity of 99%.
2 secondary outcomes
Validation of postulated non invasively measured haemoglobin value as a cut off-value 2
Time frame: five to ten minutes
Agreement between invasive and noninvasive measurement in adults and children
Time frame: five to ten 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 2019.
- Derived from this study: PubMed 39031232Mohnke K, Smetiprach J, Paumen Y, Mildenberger P, Komorek Y, Griemert EV, Wittenmeier E. Is noninvasive hemoglobin measurement suitable for children undergoing preoperative anesthesia consultation? J Clin Monit Comput. 2025 Feb;39(1):175-182. doi: 10.1007/s10877-024-01194-7. Epub 2024 Jul 20.
- Derived from this study: PubMed 33227153Wittenmeier E, Paumen Y, Mildenberger P, Smetiprach J, Pirlich N, Griemert EV, Kriege M, Engelhard K. Non-invasive haemoglobin measurement as an index test to detect pre-operative anaemia in elective surgery patients - a prospective study. Anaesthesia. 2021 May;76(5):647-654. doi: 10.1111/anae.15312. Epub 2020 Nov 23.
- Individual participant dataSharing planned: No
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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.
Eva Wittenmeier, MD principal investigator
Johannes Gutenberg University Centre, department of anaesthesiology, Langenbeckstraße 1, 55131 Mainz, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pronto® hemoglobin measurement tool in people with Anemia, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 2 inclusion and 1 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 2019. 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 Germany. 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?
Validation of a postulated noninvasively measured haemoglobin value as a cut-off value for the decision wether invasively measuring of haemoglobin concentration for preoperative patient blood management is necessary. (time frame: five to ten minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03586141, which also lists 2 linked publications.
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 2019.