Septic ShockPhase 3TRANSPORTNCT03837171
TRANSfusion in Patients With Onco-hematological Malignancies ResusciTated From Septic Shock
A Phase 3 study testing Liberal Red blood cell transfusion and Restrictive Red blood cell transfusion in people with Septic Shock and Anemia, run by Assistance Publique - Hôpitaux de Paris at 20 sites in France.
Trial summary
Septic shock is a frequent complication associated with high mortality in patients with malignancies. The best transfusion strategy (restrictive or liberal) for the resuscitation of septic shock remains a controversial issue, in relation with potentially discrepant goals of tissue oxygenation and transfusion sparing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Anemia, Cancer
- What is being tested?
- Liberal Red blood cell transfusion and Restrictive Red blood cell transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 20 sitesFrance
- Study dates
- 24 Mar 2019to 4 Mar 2024
- Phase
- Phase 3
- 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
Who may be able to join
- Age > 18 years
- Evolutive (complete remission < 2 years) malignant solid tumor or chronic or acute hematological malignancy
- Septic shock defined as:
- Presumed or documented infection
- Acute circulatory failure defined as hypotension requirement of vasoactive drugs for more than one hour (norepinephrine or epinephrine ≥ 0.1 µg/kg/min)
- Tissue hypoxia defined by arterial lactate level > 2 mmol/L within 3 hours prior to inclusion
- Hemoglobin level < 9 g/dL
- Informed consent from patients or surrogates
Who cannot join
- Acute life-threatening bleeding
- Ongoing acute coronary syndrome or any other acute ischemic condition
- End-of-life decisions at the time of ICU admission
- Refusal of transfusions for personal beliefs
- Lack of social security coverage
- Pregnancy or breastfeeding
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
CHU Amiens Picardie Site Sud
Amiens
Hopital Robert Ballanger
Aulnay-sous-Bois
Hopital Avicenne AP-HP
Bobigny
CH sud-Francilien
Corbeil
Hopital Henri Mondor AP-HP
Créteil
CHV André Mignot
Le Chesnay
Salengro, CHRU
Lille
CH Lyon Sud
Lyon
GH Édouard Herriot
Lyon
Institut Paoli Calmettes
Marseille
GH Sud Ile de France
Melun
Bel Air CHR
Metz
Mercy, CHR
Metz
CHU de Nantes
Nantes
La Source, CHR
Orléans
Hopital Cochin AP-HP
Paris, 75005
Hopital de La Pitié Salpetriere AP-HP
Paris
Hopital Saint Antoine AP-HP
Paris
Hopital Saint Louis AP-HP
Paris
Gustave Roussy
Villejuif
About this study
Official title: Stratégie Transfusionnelle érythrocytaire Dans la réanimation du Choc Septique du Patient d'Onco-hématologie : Essai randomisé Multicentrique TRANSPORT [TRANSfusion in Patients With Onco-hematological Malignancies ResusciTated From Septic Shock]
Septic shock is a frequent complication associated with high mortality in patients with malignancies. The best transfusion strategy (restrictive or liberal) for the resuscitation of septic shock remains a controversial issue, in relation with potentially discrepant goals of tissue oxygenation and transfusion sparing.
In this study, the investigators propose to address the efficacy of two RBC transfusion strategies (liberal or restrictive) in restoring appropriate tissue oxygenation as well as their tolerance.
The investigators designed a prospective randomized multicenter trial aimed at comparing liberal and restrictive RBC transfusion strategies applied during the first 48 hours of resuscitation in cancer patients with septic shock and anemia.
Read the detailed description
Septic shock is a frequent complication in patients with malignancies and remains affected with a mortality rate higher than 50%.
Red blood cell (RBC) transfusion remains a major issue for critically ill cancer patients who frequently display anemia as a result of malignant bone marrow involvement or imposed by cytotoxic treatments. However, our current practice of RBC transfusion in the intensive care unit (ICU) is drawn from general populations. Several case-control studies suggested that RBC transfusion was associated with higher mortality and increased incidence of ICU-acquired complications in critically ill patients. In 1999, a restrictive strategy of non-leucodepleted RBC transfusion to maintain hemoglobin above 7 g/dL was shown to be as effective as a liberal transfusion strategy aimed to maintain haemoglobin > 10 g/dL in critically ill patients. As of today, the current recommendations for RBC transfusion remain largely based on this study which excluded patients with a history of anemia. Leucodepletion that is now routinely implemented in France might be associated with fewer transfusion-related events. Indeed, some recent studies challenged the restrictive strategy and suggested that a higher transfusion threshold might be beneficial in septic patients for whom oxygen delivery is of paramount importance. Most importantly, a hemodynamic support algorithm for severe sepsis also known as early goal-directed therapy (EGDT) included a hematocrit target of 30%. The majority of EGDT-treated patients received RBC transfusion within the early 72 hours of resuscitation, thereby representing a major difference compared to standard treatment, but the prognostic value of RBC transfusion was not specifically assessed. A recent case-control study also suggested that RBC transfusion was an independent predictor of survival in patients with septic shock.
Cancer patients with septic shock and hemoglobin level < 9 g/dL initiation will be randomized to the interventional arm (liberal transfusion strategy to maintain hemoglobin > 9 g/dL) or to the control arm (restrictive transfusion strategy to maintain hemoglobin > 7 g/dL) in a 1:1 ratio.
Patients from the intervention arm will have their hemoglobin level maintained above 9 g/dL for the whole time under vasopressors, for a maximum of 28 days. After weaning from vasopressor, the transfusion threshold will be lowered to 7 g/dL as recommended by the SSC guidelines. In case of shock relapse requiring reintroduction of vasopressors, the transfusion threshold will be upgraded back to 9 g/dL until next catecholamine weaning.
In the control arm, the transfusion threshold will be 7 g/dL until ICU discharge regardless of catecholamine administration.
The primary objective of the study will be the restoration of tissue oxygenation as assessed by lactate clearance at 12 hours following randomization. The secondary endpoints will be related to restoration of tissue oxygenation at alternative time points (6h, 24h, 36h, 48h) as assessed as above, the 7-day, 28-day, in-ICU and in-hospital mortality rate, changes in organ failures over the first 48 hours and 7 days, duration for organ failure supports, the development of acute ischemic and thrombotic events (myocardial infarction, mesenteric ischemia, ischemic stroke, limb ischemia, deep venous thrombosis) over the first 7 days.
An interim analysis on the primary endpoint has been pre-planned at the end of the follow up of half of patients included.
- Conditions
- Septic Shock, Anemia, Cancer
- Being tested
- Liberal Red blood cell transfusion, Restrictive Red blood cell transfusion
- Keywords
- Septic Shock, Anemia, cancer, erythrocyte transfusion
- Medical subject headings
- Shock, Septic, Anemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberal Red blood cell transfusionBiological
Hemoglobin level will be maintained above 9 g/dL (liberal strategy) for the first 48 hours following randomization. After 48 hours, indications of RBC transfusions will be at the discretion of attending physicians in patients with persistent circulatory failure.
After resolution of acute circulatory failure, a 7 g/dL transfusion threshold will be recommended regardless of the allocation arm. In case of subsequent episodes of septic shock, the transfusion strategy will be at the discretion of attending physicians
Restrictive Red blood cell transfusionBiological
Hemoglobin level will be maintained above 7 g/dL (restrictive strategy) during all the stay in ICU
| Study group | Role | What they receive |
|---|---|---|
| Liberal strategy | Active comparator | Maintain a hemoglobin level > 9 g/dL during the first 48 hours of resuscitation of septic shock Receives: Biological: Liberal Red blood cell transfusion |
| Restrictive strategy | Experimental | Maintain a hemoglobin level > 7 g/dL during the resuscitation of septic shock Receives: Biological: Restrictive Red blood cell transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue oxygenation
Percentage of patients with normal arterial lactate level at 12 hours (<=2 mmol/L) or a relative decrease (or clearance) of arterial lactate level above 30% according to the formula (lactateH0 - lactateH12)/lactate H0*100.
lactateH0 : arterial lactate level at inclusion lactateH12 : arterial lactate level at 12h
Measured: 12 hours
Secondary outcomes (19)
Tissue oxygenation 6
Percentage of patients with normal arterial lactate level at 6 hours (<=2 mmol/L) or a relative decrease (or clearance) of arterial lactate level above 30% according to the formula (lactateH0 - lactateH6)/lactate H0*100.
lactateH0 : arterial lactate level at inclusion lactateH6 : arterial lactate level at 6h
Measured: 6 hours
Tissue oxygenation 24
Percentage of patients with normal arterial lactate level at 24 hours (<=2 mmol/L) or a relative decrease (or clearance) of arterial lactate level above 30% according to the formula (lactateH0 - lactateH24)/lactate H0*100.
lactateH0 : arterial lactate level at inclusion lactateH24 : arterial lactate level at 24h
Measured: 24 hours
Tissue oxygenation 48
Percentage of patients with normal arterial lactate level at 48 hours (<=2 mmol/L) or a relative decrease (or clearance) of arterial lactate level above 30% according to the formula (lactateH0 - lactateH48)/lactate H0*100.
lactateH0 : arterial lactate level at inclusion lactateH48 : arterial lactate level at 48h
Measured: 48 hours
Mortality 7
Percentage of Death at 7 days
Measured: 7 days
Mortality 28
Percentage of Death at 28 days
Measured: 28 days
ICU mortality
Percentage of Death in ICU at 28 days
Measured: 28 days
Hospital mortality
Percentage of Death in Hospital at 28 days
Measured: 28 days
Change in SOFA 24
Differences between SOFA score at inclusion (SOFA0) and SOFA score at 24 hours. The sequential organ failure assessment score (SOFA score) ranges from 0 (normal patient) to 24 (most severe patient).
Vincent JL, de Mendonça A, Cantraine F, et al. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998;26(11):1793-800.
Measured: 24 hours
Change in SOFA 48
Differences between SOFA score at inclusion (SOFA0) and SOFA score at 48 hours. The sequential organ failure assessment score (SOFA score) ranges from 0 (normal patient) to 24 (most severe patient).
Vincent JL, de Mendonça A, Cantraine F, et al. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998;26(11):1793-800.
Measured: 48 hours
Change in SOFA 72
Differences between SOFA score at inclusion (SOFA0) and SOFA score at 72 hours. The sequential organ failure assessment score (SOFA score) ranges from 0 (normal patient) to 24 (most severe patient).
Vincent JL, de Mendonça A, Cantraine F, et al. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998;26(11):1793-800.
Measured: 72 hours
Change in SOFA 7d
Differences between SOFA score at inclusion (SOFA0) and SOFA score at day 7. The sequential organ failure assessment score (SOFA score) ranges from 0 (normal patient) to 24 (most severe patient).
Vincent JL, de Mendonça A, Cantraine F, et al. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998;26(11):1793-800.
Measured: 7 days
ventilator free days
ventilator free days (VFDs) are defined as follows: VFDs=0: If the patient dies before 28 days. VFDs=(28-x): If the patient is success-fully weaned from mechanical ventilation within 28 days, where x is the number of days spent receiving mechanical ventilation.
VFDs=0: If the patient requires mechanical ventilation for 28 days or more.
Measured: 28 days
vasopressor free days
vasopressor free days (VaFDs) are defined as follows: VaFDs=0: If the patient dies before 28 days. VaFDs=(28-x): If the patient is successfully weaned from vasopressor within 28 days, where x is the number of days spent with vasopressor.
VaFDs=0: If the patient requires vasopressor for 28 days or more.
Measured: 28 days
renal replacement therapy free days
renal replacement therapy free days (RRFDs) are defined as follows: RRFDs=0: If the patient dies before 28 days. RRFDs=(28-x): If the patient is successfully weaned from renal replacement therapy within 28 days, where x is the number of days spent with vasopressor.
RRFDs=0: If the patient requires renal replacement therapy for 28 days or more.
Measured: 28 days
ICU length of stay
time spent in ICU from inclusion censored at 28 days
Measured: 28 days
Ischemic
Incidence of ischemic event during the first 28 days (stroke, myocardial infarction, mesenteric infarction)
Measured: 28 days
thrombosis
Incidence of deep venous thrombosis or pulmonary embolism during the first 28 days
Measured: 28 days
TRIALI
Incidence of transfusion-related acute lung injury during the first 28 days
Measured: 28 days
Transfusion reaction
Incidence of side effects of transfusions during the first 28 days (fever, chills, hemolysis)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start24 Mar 2019
- Primary completion28 Feb 2024
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837171
- Sponsor's protocol ID
- K170913J
- Other IDs
- 2018-A00592-53
- Acronym
- TRANSPORT
- Status last verified
- Jun 2024
- First submitted
- 8 Feb 2019
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stratégie Transfusionnelle érythrocytaire Dans la réanimation du Choc Septique du Patient d'Onco-hématologie : Essai randomisé Multicentrique TRANSPORT [TRANSfusion in Patients With Onco-hematological Malignancies ResusciTated From Septic Shock]
- ClinicalTrials.gov ID
- NCT03837171
- Acronym / sponsor ID
- TRANSPORT / K170913J
- Conditions
- Septic Shock, Anemia, Cancer
- Keywords
- Septic Shock, Anemia, cancer, erythrocyte transfusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 24 Mar 2019 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 12 Feb 2019 (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.
Septic shock is a frequent complication associated with high mortality in patients with malignancies. The best transfusion strategy (restrictive or liberal) for the resuscitation of septic shock remains a controversial issue, in relation with potentially discrepant goals of tissue oxygenation and transfusion sparing.
In this study, the investigators propose to address the efficacy of two RBC transfusion strategies (liberal or restrictive) in restoring appropriate tissue oxygenation as well as their tolerance.
The investigators designed a prospective randomized multicenter trial aimed at comparing liberal and restrictive RBC transfusion strategies applied during the first 48 hours of resuscitation in cancer patients with septic shock and anemia.
Detailed description
Septic shock is a frequent complication in patients with malignancies and remains affected with a mortality rate higher than 50%.
Red blood cell (RBC) transfusion remains a major issue for critically ill cancer patients who frequently display anemia as a result of malignant bone marrow involvement or imposed by cytotoxic treatments. However, our current practice of RBC transfusion in the intensive care unit (ICU) is drawn from general populations. Several case-control studies suggested that RBC transfusion was associated with higher mortality and increased incidence of ICU-acquired complications in critically ill patients. In 1999, a restrictive strategy of non-leucodepleted RBC transfusion to maintain hemoglobin above 7 g/dL was shown to be as effective as a liberal transfusion strategy aimed to maintain haemoglobin > 10 g/dL in critically ill patients. As of today, the current recommendations for RBC transfusion remain largely based on this study which excluded patients with a history of anemia. Leucodepletion that is now routinely implemented in France might be associated with fewer transfusion-related events. Indeed, some recent studies challenged the restrictive strategy and suggested that a higher transfusion threshold might be beneficial in septic patients for whom oxygen delivery is of paramount importance. Most importantly, a hemodynamic support algorithm for severe sepsis also known as early goal-directed therapy (EGDT) included a hematocrit target of 30%. The majority of EGDT-treated patients received RBC transfusion within the early 72 hours of resuscitation, thereby representing a major difference compared to standard treatment, but the prognostic value of RBC transfusion was not specifically assessed. A recent case-control study also suggested that RBC transfusion was an independent predictor of survival in patients with septic shock.
Cancer patients with septic shock and hemoglobin level < 9 g/dL initiation will be randomized to the interventional arm (liberal transfusion strategy to maintain hemoglobin > 9 g/dL) or to the control arm (restrictive transfusion strategy to maintain hemoglobin > 7 g/dL) in a 1:1 ratio.
Patients from the intervention arm will have their hemoglobin level maintained above 9 g/dL for the whole time under vasopressors, for a maximum of 28 days. After weaning from vasopressor, the transfusion threshold will be lowered to 7 g/dL as recommended by the SSC guidelines. In case of shock relapse requiring reintroduction of vasopressors, the transfusion threshold will be upgraded back to 9 g/dL until next catecholamine weaning.
In the control arm, the transfusion threshold will be 7 g/dL until ICU discharge regardless of catecholamine administration.
The primary objective of the study will be the restoration of tissue oxygenation as assessed by lactate clearance at 12 hours following randomization. The secondary endpoints will be related to restoration of tissue oxygenation at alternative time points (6h, 24h, 36h, 48h) as assessed as above, the 7-day, 28-day, in-ICU and in-hospital mortality rate, changes in organ failures over the first 48 hours and 7 days, duration for organ failure supports, the development of acute ischemic and thrombotic events (myocardial infarction, mesenteric ischemia, ischemic stroke, limb ischemia, deep venous thrombosis) over the first 7 days.
An interim analysis on the primary endpoint has been pre-planned at the end of the follow up of half of patients included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal strategy | Active comparator | Biological: Liberal Red blood cell transfusionMaintain a hemoglobin level > 9 g/dL during the first 48 hours of resuscitation of septic shock |
| Restrictive strategy | Experimental | Biological: Restrictive Red blood cell transfusionMaintain a hemoglobin level > 7 g/dL during the resuscitation of septic shock |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- Evolutive (complete remission < 2 years) malignant solid tumor or chronic or acute hematological malignancy
- Septic shock defined as:
- Presumed or documented infection
- Acute circulatory failure defined as hypotension requirement of vasoactive drugs for more than one hour (norepinephrine or epinephrine ≥ 0.1 µg/kg/min)
Key exclusion criteria (6 listed)
- Acute life-threatening bleeding
- Ongoing acute coronary syndrome or any other acute ischemic condition
- End-of-life decisions at the time of ICU admission
- Refusal of transfusions for personal beliefs
- Lack of social security coverage
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 |
|---|---|---|
| Liberal Red blood cell transfusionHemoglobin level will be maintained above 9 g/dL (liberal strategy) for the first 48 hours following randomization. After 48 hours, indications of RBC transfusions will be at the discretion of attending physicians in patients with persistent circulatory failure. After resolution of acute circulatory failure, a 7 g/dL transfusion threshold will be recommended regardless of the allocation arm. In case of subsequent episodes of septic shock, the transfusion strategy will be at the discretion of attending physicians | Biological | Liberal strategy |
| Restrictive Red blood cell transfusionHemoglobin level will be maintained above 7 g/dL (restrictive strategy) during all the stay in ICU | Biological | Restrictive strategy |
Primary outcome
Tissue oxygenation
Time frame: 12 hours
Percentage of patients with normal arterial lactate level at 12 hours (<=2 mmol/L) or a relative decrease (or clearance) of arterial lactate level above 30% according to the formula (lactateH0 - lactateH12)/lactate H0*100. lactateH0 : arterial lactate level at inclusion lactateH12 : arterial lactate level at 12h
19 secondary outcomes
Tissue oxygenation 6
Time frame: 6 hours
Tissue oxygenation 24
Time frame: 24 hours
Tissue oxygenation 48
Time frame: 48 hours
Mortality 7
Time frame: 7 days
Mortality 28
Time frame: 28 days
ICU mortality
Time frame: 28 days
Hospital mortality
Time frame: 28 days
Change in SOFA 24
Time frame: 24 hours
Change in SOFA 48
Time frame: 48 hours
Change in SOFA 72
Time frame: 72 hours
Change in SOFA 7d
Time frame: 7 days
ventilator free days
Time frame: 28 days
vasopressor free days
Time frame: 28 days
renal replacement therapy free days
Time frame: 28 days
ICU length of stay
Time frame: 28 days
Ischemic
Time frame: 28 days
thrombosis
Time frame: 28 days
TRIALI
Time frame: 28 days
Transfusion reaction
Time frame: 28 days
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 25 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Sepsis
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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liberal Red blood cell transfusion and Restrictive Red blood cell transfusion in people with Septic Shock and Anemia, run by Assistance Publique - Hôpitaux de Paris at 20 sites 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 8 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: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Tissue oxygenation (time frame: 12 hours). 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 25 Jun 2024.