Brain InjuryMICRONORNCT05285514
Macro- and Microcirculation Crosstalk in Brain-damaged Patients Under Anesthesia or in Intensive Care
An observational study of Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In patients with severe brain injury, maintenance and control of blood pressure is at the very first point in the management strategy, whether in anesthesia or in intensive care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury
- What is being tested?
- Comparison of macro- and microcirculatory parameters
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2023to Jul 2025
- 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: Adult patients (≥ 18 years old) with brain damage, undergoing general anesthesia or intensive care justifying, due to their severity, monitoring of blood pressure and cardiac output.
Who may be able to join
- Adult patients (≥ 18 years old)
- With brain damage
- Benefiting from general anesthesia or resuscitation justifying the placement of an arterial catheter and monitoring of cardiac output
- With hypotension or arterial hypertension requiring intravenous administration of a vasoactive agent to meet the target cerebral perfusion pressure (CPP) of 60-70 mmHg
- Not subject to a measure of legal protection (tutorship/curatorship)
- Patients informed and having expressed their non-objection to participation in this research, or, where applicable, a person of trust / family member / relative of the patient who is unable to express her or his agreement
Who cannot join
- Patients under the age of 18
- Pregnant woman
- Patient without affiliation to a social security scheme
- Patient, or, where applicable, person of trust / family member / relative of the patient unable to express her or his agreement, opposed to participation in the study
- Patient subject to a legal protection measure
- Patient benefiting from the State medical assistance (AME) program
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care
Paris, 75010
Joaquim MATEO, MD, +33 (0)1 49 95 83 74, joaquim.mateo@aphp.fr
Fabrice VALLEE, MD, PhD, +33 (0)1 49 95 80 71, vallee@gmail.com
About this study
Official title: Analysis of the Macro-microcirculatory Coupling in the Course of Using the Vasoactive Substances During Anesthesia-resuscitation of Brain-damaged Patients
In patients with severe brain injury, maintenance and control of blood pressure is at the very first point in the management strategy, whether in anesthesia or in intensive care. In order to restore cerebral perfusion pressure (CPP) to appropriate levels (60-70 mmHg) while ensuring optimal perfusion of other vital organs, intravenous administration of vasodilator, inodilator or vasoconstrictor vasoactive agents is commonly used.
These vasoactive agents, widely used to correct hypotension or hypertension, have their own effects on the load conditions of the left ventricle and the tone of the arterial tree, but also have effects on the microcirculation.
Read more
The microcirculatory status of a tissue cannot be reliably predicted by considering only the macrocirculatory parameters usually measured.
Therefore, in situations where organ perfusion is inadequate or compromised, patient management that includes the integration of the impact of vasoactive agents on the microcirculation seems essential for comprehensive hemodynamic treatment.
The non-invasive study of microcirculatory perfusion and its interactions with the macrocirculatory network, using a minimally invasive method such as videomicroscopy, should allow a better use of the treatments used.
For cerebral patients, routine management already includes very complete monitoring of all cardiopulmonary and cerebral systemic parameters.
It is therefore imperative to study and propose new minimally invasive modalities for monitoring the microcirculation in order to define new therapeutic targets that take into account the microcirculatory compartment.
Read the detailed description
In patients with severe brain injury, maintenance and control of blood pressure is at the primary focus of the management strategy in both anesthesia and intensive care. In order to restore cerebral perfusion pressure (CPP) to appropriate levels (60-70 mmHg) while ensuring optimal perfusion of other vital organs, intravenous administration of vasodilator, ino-dilator or vasoconstrictor agents is widely used.
These vasoactive agents widely used to correct hypotension or hypertension have their own effects on left ventricular loading conditions, arterial tree tone, but also effects on microcirculation.
Currently, the vast majority of anaesthesias and organ resuscitations are carried out from a macrocirculatory view of the system. Hemodynamic optimization is then based on the monitoring of macrocirculatory parameters such as arterial pressure, and sometimes cardiac output coupled with parameters of adequacy of tissue oxygenation (arterial and venous O2 saturation).
The microcirculatory status of a tissue cannot be reliably predicted by considering only the usually measured macrocirculatory parameters. Peripheral capillary perfusion pressure is the result of the coupling between peripheral microcirculatory tone and resistance and macrocirculatory impedance.
The response of microvessels to the various vasoactive agents widely used in the clinic has been little studied.
However, it should be noted that excessive use of vasoconstrictor amines, particularly in the presence of hypovolemia, may, paradoxically to the macrocirculatory impression, induce closure of the capillary network and aggravate tissue ischemia. This capillary de-recruitment is due in particular to the dissipation of pressure in the systemic arterial system, due to the excessively high peripheral resistances and fatally leads to a rarefaction of the open capillaries.
In addition, the increased macrocirculatory impedance imposes a myocardial workload that may cause a decrease in cardiac output, amplifying the tissue damage. This leads to a new situation of uncoupling, characterized by decreased macrocirculatory flow and elevated microcirculatory resistance.
This is why, in situations where organ perfusion is inadequate or weakened, patient management that includes the integration of the impact of vasoactive agents on the microcirculation seems essential for global hemodynamic treatment.
Impaired microcirculation is a key pathophysiological factor in organ failure and death in patients. The impact of organ failure (renal, respiratory, cardiac, etc.) on the quality of cerebral oxygenation is major and conditions the brain's recovery potential. Organ failure by its repercussions on the conditions of brain recovery severely worsens the prognosis of brain damaged patients (secondary brain insults of systemic origin (SBISOs)
In order to recognize and avoid the pitfalls associated with these aortocapillary uncoupling mechanisms, specific monitoring of microcirculatory flow and tissue perfusion during the administration of vasoactive agents is largely relevant. The major obstacle is the difficulty of studying microcirculatory behavior at the bedside in a non or minimally invasive manner.
Direct visualization of the capillary circulation in vivo is now possible using a minimally invasive technique of orthogonal spectral polarization (OSP) videomicroscopy and, more recently, Sidestream Dark Field imaging (SDF).
This last technique, validated in humans mainly in septic shock situations, uses a polarized light source whose absorbance by hemoglobin and reflection by other tissues allows the construction of a contrasted image. This technique allows the visualization of capillary networks on the surface of solid organs covered with a thin epithelial layer to a depth of about 300 µm. An analysis of the recorded image assisted by calculation software allows the semi-quantitative calculation of capillary density (proportion of perfused vessels; PPVSL), capillary flow (Microcirculatory Flow Index; MFISL) and heterogeneity (heterogeneity index; HETSL) of these.
To date, several non-invasive techniques are available, each measuring different parameters specific to this microcirculation:
Capillary density, capillary or tissue flow estimation, hemoglobin saturation, oxygenation and tissue CO2 pressure measurements.
The non-invasive study of microcirculatory perfusion and its interactions with the macrocirculatory network, thanks to a minimally invasive method such as videomicroscopy, should allow a better use of the treatments used.
Overall, the trend in anaesthesia and intensive care is increasingly towards individualized management, and the use of monitoring (macro- and microcirculatory) associated with a thorough knowledge of the treatments used (vasoconstrictors, vasodilators and vascular filling in particular) seems to be an essential basis for these considerations.
The empirical use of vasoactive agents, without specific monitoring of these effects, and the unpredictable impact of changes in one of the two compartments on the final state of the system during adequate macrocirculatory resuscitation could even be deleterious at the microcirculatory level.
These pathophysiological concepts specific to macro/microcirculation cross-talk demonstrate the imperative of developing monitoring specific to the microvascular network in critical patients.
The techniques have evolved and the tools are now available and can be used safely in patients.
For brain-damaged patients, routine management already includes a very complete monitoring including all systemic cardio-pulmonary and cerebral parameters. Participants receive interventions as part of routine medical care to restore Cerebral Perfusion pressure (CPP) to appropriate levels (60-70 mmHg)
The availability of minimally invasive monitoring tools of the microcirculation such as videomicroscopy allows the study of the functional capillary situation according to the vasoactive agent used.
The study of microcirculatory perfusion and its interactions with the macrocirculatory network, using a minimally invasive method such as videomicroscopy, should allow a better use of the treatments used.
- Conditions
- Brain Injury
- Being tested
- Comparison of macro- and microcirculatory parameters
- Keywords
- Hemodynamic monitoring, Microcirculation, Macro-microcirculation crosstalk, Vasoactive agents
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of macro- and microcirculatory parametersDiagnostic test
Microcirculation examination using sublingual videomicroscopy, tissue O2 saturation (StO2) by NIRS and transcutaneous CO2 pressure (tcpCO2) monitoring, in conjunction with macrocirculatory parameters measures including cardiac output, arterial pressure and pulsed O2 saturation, in order to establish the relationship between the macrocirculatory changes in blood pressure and cardiac output and the microcirculatory flow and capillary density during vasoactive agent use." . Participants receive interventions as part of routine medical care to restore Cerebral Perfusion pressure (CPP) to appropriate levels (60-70 mmHg)
| Study group | Role | What they receive |
|---|---|---|
| Brain-damaged patients under anesthesia and requiring the administration of a vasoactive agent | Patients with severe brain injuries over 18 years of age are eligible to participate in this protocol: head trauma, subarachnoid hemorrhage, ischemic or hemorrhagic stroke and requiring the administration of a vasoactive agent as part of routine medical care to restore Cerebral Perfusion pressure (CPP). Receives: Diagnostic Test: Comparison of macro- and microcirculatory parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary density
For all patients, Capillary density by sublingual video microscopy (proportion of perfused vessels; PPVSL / percentage and the heterogeneity index; HETSL / H-unit) will be collected in separate time periods:
- Baseline before administration of the vasoactive agent
- After 5 minutes
- After stabilization 15 minutes
Measured: Duration of the surgical intervention (1 day)
Microcirculatory flow
For all patients, Capillary flow estimation using sublingual videomicroscopy (Microcirculatory Flow Index MFISL/ unit FI) will be collected in separate time periods:
- Baseline before administration of the vasoactive agent
- After 5 minutes
- After stabilization 15 minutes
Measured: Duration of the surgical intervention (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study startJun 2023 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM UMR-942, Paris, France, LMS Polytechnique, M3DISIM Inria Université Paris-Saclay
- Responsible party
- Sponsor
- Investigators
- Joaquim MATEO, MD, Study director, AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive CareFabrice VALLEE, MD, PhD, Principal investigator, AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285514
- Sponsor's protocol ID
- APHP211317
- Other IDs
- 2021-A02375-36
- Acronym
- MICRONOR
- Status last verified
- Apr 2023
- First submitted
- 9 Mar 2022
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Macro-microcirculatory Coupling in the Course of Using the Vasoactive Substances During Anesthesia-resuscitation of Brain-damaged Patients
- ClinicalTrials.gov ID
- NCT05285514
- Acronym / sponsor ID
- MICRONOR / APHP211317
- Conditions
- Brain Injury
- Keywords
- Hemodynamic monitoring, Microcirculation, Macro-microcirculation crosstalk, Vasoactive agents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- INSERM UMR-942, Paris, France, LMS Polytechnique, M3DISIM Inria Université Paris-Saclay
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 17 Mar 2022 (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.
In patients with severe brain injury, maintenance and control of blood pressure is at the very first point in the management strategy, whether in anesthesia or in intensive care. In order to restore cerebral perfusion pressure (CPP) to appropriate levels (60-70 mmHg) while ensuring optimal perfusion of other vital organs, intravenous administration of vasodilator, inodilator or vasoconstrictor vasoactive agents is commonly used.
These vasoactive agents, widely used to correct hypotension or hypertension, have their own effects on the load conditions of the left ventricle and the tone of the arterial tree, but also have effects on the microcirculation.
The microcirculatory status of a tissue cannot be reliably predicted by considering only the macrocirculatory parameters usually measured.
Therefore, in situations where organ perfusion is inadequate or compromised, patient management that includes the integration of the impact of vasoactive agents on the microcirculation seems essential for comprehensive hemodynamic treatment.
The non-invasive study of microcirculatory perfusion and its interactions with the macrocirculatory network, using a minimally invasive method such as videomicroscopy, should allow a better use of the treatments used.
For cerebral patients, routine management already includes very complete monitoring of all cardiopulmonary and cerebral systemic parameters.
It is therefore imperative to study and propose new minimally invasive modalities for monitoring the microcirculation in order to define new therapeutic targets that take into account the microcirculatory compartment.
Detailed description
In patients with severe brain injury, maintenance and control of blood pressure is at the primary focus of the management strategy in both anesthesia and intensive care. In order to restore cerebral perfusion pressure (CPP) to appropriate levels (60-70 mmHg) while ensuring optimal perfusion of other vital organs, intravenous administration of vasodilator, ino-dilator or vasoconstrictor agents is widely used.
These vasoactive agents widely used to correct hypotension or hypertension have their own effects on left ventricular loading conditions, arterial tree tone, but also effects on microcirculation.
Currently, the vast majority of anaesthesias and organ resuscitations are carried out from a macrocirculatory view of the system. Hemodynamic optimization is then based on the monitoring of macrocirculatory parameters such as arterial pressure, and sometimes cardiac output coupled with parameters of adequacy of tissue oxygenation (arterial and venous O2 saturation).
The microcirculatory status of a tissue cannot be reliably predicted by considering only the usually measured macrocirculatory parameters. Peripheral capillary perfusion pressure is the result of the coupling between peripheral microcirculatory tone and resistance and macrocirculatory impedance.
The response of microvessels to the various vasoactive agents widely used in the clinic has been little studied.
However, it should be noted that excessive use of vasoconstrictor amines, particularly in the presence of hypovolemia, may, paradoxically to the macrocirculatory impression, induce closure of the capillary network and aggravate tissue ischemia. This capillary de-recruitment is due in particular to the dissipation of pressure in the systemic arterial system, due to the excessively high peripheral resistances and fatally leads to a rarefaction of the open capillaries.
In addition, the increased macrocirculatory impedance imposes a myocardial workload that may cause a decrease in cardiac output, amplifying the tissue damage. This leads to a new situation of uncoupling, characterized by decreased macrocirculatory flow and elevated microcirculatory resistance.
This is why, in situations where organ perfusion is inadequate or weakened, patient management that includes the integration of the impact of vasoactive agents on the microcirculation seems essential for global hemodynamic treatment.
Impaired microcirculation is a key pathophysiological factor in organ failure and death in patients. The impact of organ failure (renal, respiratory, cardiac, etc.) on the quality of cerebral oxygenation is major and conditions the brain's recovery potential. Organ failure by its repercussions on the conditions of brain recovery severely worsens the prognosis of brain damaged patients (secondary brain insults of systemic origin (SBISOs)
In order to recognize and avoid the pitfalls associated with these aortocapillary uncoupling mechanisms, specific monitoring of microcirculatory flow and tissue perfusion during the administration of vasoactive agents is largely relevant. The major obstacle is the difficulty of studying microcirculatory behavior at the bedside in a non or minimally invasive manner.
Direct visualization of the capillary circulation in vivo is now possible using a minimally invasive technique of orthogonal spectral polarization (OSP) videomicroscopy and, more recently, Sidestream Dark Field imaging (SDF).
This last technique, validated in humans mainly in septic shock situations, uses a polarized light source whose absorbance by hemoglobin and reflection by other tissues allows the construction of a contrasted image. This technique allows the visualization of capillary networks on the surface of solid organs covered with a thin epithelial layer to a depth of about 300 µm. An analysis of the recorded image assisted by calculation software allows the semi-quantitative calculation of capillary density (proportion of perfused vessels; PPVSL), capillary flow (Microcirculatory Flow Index; MFISL) and heterogeneity (heterogeneity index; HETSL) of these.
To date, several non-invasive techniques are available, each measuring different parameters specific to this microcirculation:
Capillary density, capillary or tissue flow estimation, hemoglobin saturation, oxygenation and tissue CO2 pressure measurements.
The non-invasive study of microcirculatory perfusion and its interactions with the macrocirculatory network, thanks to a minimally invasive method such as videomicroscopy, should allow a better use of the treatments used.
Overall, the trend in anaesthesia and intensive care is increasingly towards individualized management, and the use of monitoring (macro- and microcirculatory) associated with a thorough knowledge of the treatments used (vasoconstrictors, vasodilators and vascular filling in particular) seems to be an essential basis for these considerations.
The empirical use of vasoactive agents, without specific monitoring of these effects, and the unpredictable impact of changes in one of the two compartments on the final state of the system during adequate macrocirculatory resuscitation could even be deleterious at the microcirculatory level.
These pathophysiological concepts specific to macro/microcirculation cross-talk demonstrate the imperative of developing monitoring specific to the microvascular network in critical patients.
The techniques have evolved and the tools are now available and can be used safely in patients.
For brain-damaged patients, routine management already includes a very complete monitoring including all systemic cardio-pulmonary and cerebral parameters. Participants receive interventions as part of routine medical care to restore Cerebral Perfusion pressure (CPP) to appropriate levels (60-70 mmHg)
The availability of minimally invasive monitoring tools of the microcirculation such as videomicroscopy allows the study of the functional capillary situation according to the vasoactive agent used.
The study of microcirculatory perfusion and its interactions with the macrocirculatory network, using a minimally invasive method such as videomicroscopy, should allow a better use of the treatments used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain-damaged patients under anesthesia and requiring the administration of a vasoactive agent | – | Diagnostic Test: Comparison of macro- and microcirculatory parametersPatients with severe brain injuries over 18 years of age are eligible to participate in this protocol: head trauma, subarachnoid hemorrhage, ischemic or hemorrhagic stroke and requiring the administration of a vasoactive agent as part of routine medical care to restore Cerebral Perfusion pressure (CPP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥ 18 years old) with brain damage, undergoing general anesthesia or intensive care justifying, due to their severity, monitoring of blood pressure and cardiac output.
Key inclusion criteria (6 listed)
- Adult patients (≥ 18 years old)
- With brain damage
- Benefiting from general anesthesia or resuscitation justifying the placement of an arterial catheter and monitoring of cardiac output
- With hypotension or arterial hypertension requiring intravenous administration of a vasoactive agent to meet the target cerebral perfusion pressure (CPP) of 60-70 mmHg
- Not subject to a measure of legal protection (tutorship/curatorship)
Key exclusion criteria (6 listed)
- Patients under the age of 18
- Pregnant woman
- Patient without affiliation to a social security scheme
- Patient, or, where applicable, person of trust / family member / relative of the patient unable to express her or his agreement, opposed to participation in the study
- Patient subject to a legal protection measure
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 |
|---|---|---|
| Comparison of macro- and microcirculatory parametersMicrocirculation examination using sublingual videomicroscopy, tissue O2 saturation (StO2) by NIRS and transcutaneous CO2 pressure (tcpCO2) monitoring, in conjunction with macrocirculatory parameters measures including cardiac output, arterial pressure and pulsed O2 saturation, in order to establish the relationship between the macrocirculatory changes in blood pressure and cardiac output and the microcirculatory flow and capillary density during vasoactive agent use." . Participants receive interventions as part of routine medical care to restore Cerebral Perfusion pressure (CPP) to appropriate levels (60-70 mmHg) | Diagnostic test | Brain-damaged patients under anesthesia and requiring the administration of a vasoactive agent |
Primary outcome
Capillary density
Time frame: Duration of the surgical intervention (1 day)
For all patients, Capillary density by sublingual video microscopy (proportion of perfused vessels; PPVSL / percentage and the heterogeneity index; HETSL / H-unit) will be collected in separate time periods: 1. Baseline before administration of the vasoactive agent 2. After 5 minutes 3. After stabilization 15 minutes
Microcirculatory flow
Time frame: Duration of the surgical intervention (1 day)
For all patients, Capillary flow estimation using sublingual videomicroscopy (Microcirculatory Flow Index MFISL/ unit FI) will be collected in separate time periods: 1. Baseline before administration of the vasoactive agent 2. After 5 minutes 3. After stabilization 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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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.
Joaquim MATEO, MD study director
AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care
Fabrice VALLEE, MD, PhD principal investigator
AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care
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 Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joaquim MATEO, MD (+33 (0)1 49 95 83 74, joaquim.mateo@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capillary density (time frame: Duration of the surgical intervention (1 day)). 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 27 Apr 2023.