HemorrhageNCT03194581
Normoxic Challenges Utility to Evaluate Blood Loss
An observational study of Hemorrhage, run by Centro Hospitalar do Tâmega e Sousa at 1 site in Portugal.
Trial summary
This study will evaluate the impact of repeated normoxic challenges on cerebral oxygenation as a measure of the effect of blood loss on DO2 during surgical procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage
- What is being tested?
- Cerebral oxygenation
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2017to 30 Sep 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients submitted to surgery with high risk of blood loss
Who may be able to join
- Elective surgery
- High risk of intraoperative blood loss
- General anaesthesia
Who cannot join
- Respiratory insufficiency
- Ischemic heart disease
- Stroke
- ASA classification > 3
- Laparoscopic surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Normoxic Challenges Utility to Evaluate Blood Loss Through Cerebral Oxygenation
This study will evaluate the impact of repeated normoxic challenges on cerebral oxygenation as a measure of the effect of blood loss on DO2 during surgical procedures.
- Conditions
- Hemorrhage
- Being tested
- Cerebral oxygenation
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral oxygenationDevice
Evaluate cerebral oxygenation using normoxic challenges
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cerebral regional oxygen saturation
Measured: Before and 3 minutes after normoxic challenges
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start1 Oct 2017
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Why it stopped: Profissional reasons, not related with the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar do Tâmega e Sousa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Marques da Cunha, Centro Hospitalar do Tâmega e Sousa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194581
- Sponsor's protocol ID
- HEMOX
- Status last verified
- Mar 2022
- First submitted
- 12 Jun 2017
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normoxic Challenges Utility to Evaluate Blood Loss Through Cerebral Oxygenation
- ClinicalTrials.gov ID
- NCT03194581
- Acronym / sponsor ID
- HEMOX
- Conditions
- Hemorrhage
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Profissional reasons, not related with the study
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centro Hospitalar do Tâmega e SousaUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 21 Jun 2017 (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.
This study will evaluate the impact of repeated normoxic challenges on cerebral oxygenation as a measure of the effect of blood loss on DO2 during surgical procedures.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients submitted to surgery with high risk of blood loss
Key inclusion criteria (3 listed)
- Elective surgery
- High risk of intraoperative blood loss
- General anaesthesia
Key exclusion criteria (5 listed)
- Respiratory insufficiency
- Ischemic heart disease
- Stroke
- ASA classification > 3
- Laparoscopic surgery
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 |
|---|---|---|
| Cerebral oxygenationEvaluate cerebral oxygenation using normoxic challenges | Device | – |
Primary outcome
Change in cerebral regional oxygen saturation
Time frame: Before and 3 minutes after normoxic challenges
Results and safety
The study was stopped early (reason given: Profissional reasons, not related with the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hemorrhage, run by Centro Hospitalar do Tâmega e Sousa at 1 site in Portugal.
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 5 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: stopped early, as of the sponsor's last update on 22 Mar 2022. 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 Portugal. 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 was stopped early (reason given: Profissional reasons, not related with the study). Results are not available in the source record.
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?
Change in cerebral regional oxygen saturation (time frame: Before and 3 minutes after normoxic challenges). 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 22 Mar 2022.