Brain Ischemia HypoxiaBOTTOMLINECSNCT04896736
Multisite Tissue Oxygenation Guided Perioperative Care in Cardiac Surgery
A study testing Multisite tissue oxygenation-guided care in people with Brain Ischemia Hypoxia and Muscle; Ischemic, run by Yale University at 1 site in China.
Trial summary
The BOTTOMLINE-CS trial is an international, open, single-center, pragmatic, randomised controlled trial to investigate whether multisite tissue oxygen saturation monitoring-guided perioperative care reduces composite complications within 30 days of randomization in off-pump coronary artery bypass grafting. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Brain Ischemia Hypoxia, Muscle; Ischemic, Muscle Hypoxia
- What is being tested?
- Multisite tissue oxygenation-guided care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,960 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2021to 2 Feb 2024
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 60 years scheduled for elective off-pump CABG.
Who cannot join
- Inability or refusal to provide consent of participation
- Preoperative requirement of respiratory support (intubation, CPAP or BiPAP, or high-flow oxygen (>10 L/min))
- Preoperative requirement of external cardiac assist device
- Urgent or emergent surgery
- Patients expected to die within 30 days of randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multisite Tissue Oxygenation Guided Perioperative Care to Reduce Composite Complications in Cardiac Surgical Patients: the BOTTOMLINE-CS Trial
The BOTTOMLINE-CS trial is an international, open, single-center, pragmatic, randomised controlled trial to investigate whether multisite tissue oxygen saturation monitoring-guided perioperative care reduces composite complications within 30 days of randomization in off-pump coronary artery bypass grafting.
Read the detailed description
Short title: BOTTOMLINE-CS trial Methodology: International, open, single-center, pragmatic, randomised controlled trial Research sites: Tianjin Chest Hospital Objectives: To investigate whether multisite tissue oxygen saturation monitoring-guided perioperative care reduces composite complications within 30 days of randomization in off-pump coronary artery bypass grafting Number of patients: 1960 patients (980 per arm, two arms) Inclusion criteria: Patients aged ≥ 60 years undergoing elective off-pump coronary artery bypass grafting Exclusion criteria: Patient refusal, clinician refusal, preoperative requirement of respiratory support (intubation, CPAP or BiPAP, or high-flow oxygen (>10 L/min)), preoperative requirement of external cardiac assist devices, emergent or urgent surgery, patients expected to die within 30 days, current participation in another clinical trial Statistical analysis: Analyses will be performed on a modified intention-to-treat basis including all randomized patients who had undergone the scheduled surgery and had the record of the primary outcome. Summary statistics for each group, treatment effects, 95% confidence intervals, and p values will be presented for primary and secondary outcomes, and process measures. The primary outcome is a composite of complications arising within 30 days from randomization and will be analyzed using a logistic regression model.
Proposed start date: May 1, 2021 (First patient to be recruited) Proposed end date: April 30, 2023 (Last patient to be recruited) Study duration: 48 months (Starting from the first patient recruitment, spanning patient recruitment, data analysis, and manuscript writing and submission)
- Conditions
- Brain Ischemia Hypoxia, Muscle; Ischemic, Muscle Hypoxia
- Being tested
- Multisite tissue oxygenation-guided care, Usual care
- Keywords
- Cerebral Tissue Oxygen Saturation, Muscular Tissue Oxygen Saturation, Cardiac Surgery, Complications, Multisite Tissue Oxygenation Monitoring
- Medical subject headings
- Hypoxia-Ischemia, Brain, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisite tissue oxygenation-guided careOther
The following intervention algorithm is intended to be used as a guidance only. We emphasize the different aspects that can cause changes in SctO2/SstO2 in a systematic approach. We avoid recommending a concrete drug and method of dosing for a specific condition.
Manage tissue perfusion Preload: overall picture including direct observation of the heart, findings of echocardiography, urine output, blood loss, labs results, HR, BP, PPV, SVV, fluid responsiveness (SV increase >/= 10% following 250 ml fluid bolus) Contractility: direct observation of the heart, findings of echocardiography Stroke volume and heart rate: important determinants of CO Systemic vascular resistance: important determinant of BP Regional vascular resistance: important determinant of tissue perfusion along with perfusion pressure Maintain autoregulation: normalize CO2, avoid potent vasodilators
Manage arterial blood oxygen content
Manage tissue metabolic activity
Usual careOther
Usual care in this study means the standard perioperative care. Patients who are meant to receive usual care will receive both cerebral and muscular tissue oxygen saturation monitoring; however, the monitor screen will be covered and the monitoring data will not be used to guide clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Multisite tissue oxygenation monitoring-guided care | Experimental | Details are as follows. • Monitoring: SctO2 monitored using two probes placed on left and right forehead. SstO2 monitored using one probe placed over the forearm brachioradialis muscle on the arm not used for non-invasive blood pressure monitoring.
• Baseline: The first baseline is measured 12-48 hours before surgery, with the patient supine, awake, calm, eyes closed, and breathing room air or oxygen that is equivalent to the home oxygen rate for patients using home oxygen.
* Goals: Maintain both SctO2 and SstO2 within 90-110% of the baseline level.
* Trigger of intervention: SctO2/SstO2 outside of the 90-110% baseline range.
* Diagnosis:
* Care team: The caregivers providing SctO2/SstO2-guided care will be trained and given the opportunity to use the intervention protocol in at least 20 patients before the formal study.
* Treatments: Refer to the algorithm to restore SctO2/SstO2 within 90-110% baseline range. Receives: Other: Multisite tissue oxygenation-guided care |
| Usual care | Active comparator | Patients in the control group will be managed by clinical staff according to usual care. Patients in this group will be monitored using the same tissue oximeter used in the intervention group; however, the screen will be covered by an opaque cloth to prohibit the care givers seeing the monitoring data. The same baseline measurements will be performed in patients allocated to the usual care group. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite complication
The primary outcome is a collapsed (one or more) composite of the following complications with a Clavien-Dindo grade II or greater arising within 30 days of randomization (randomization and surgery are performed on the same day). The patient is regarded as having the event of composite complications if any of the following complications occur (i.e., yes); otherwise, the patient is regarded as not having the event of composite complications. The percentage of patients having the event of composite complications will be used in the primary analysis.
- Brain complications (delirium, cognition decline, stroke);
- Cardiac complications (non-fatal cardiac arrest, myocardial injury, heart failure, new-onset symptomatic ventricular arrhythmia);
- Respiratory failure;
- Renal complications (AKI stages II and III);
- Infectious complications;
- Death.
Measured: from the day of surgery (i.e., day 0) until postoperative day 30 for a total of 31 days (individual components may vary)
Secondary outcomes (9)
Atrial fibrillation
Atrial fibrillation
A new diagnosis of AF per the current standard.
Measured: from the day of surgery until postoperative day 30
Postoperative delirium
Postoperative delirium (assessed using CAM-ICU Worksheet for patients in PACU and ICU, or CAM for patients on the floor). The validated Chinese version will be used for assessment.
Delirium will be formally assessed as early in the morning as practical and early evening for the initial five postoperative days while patients remain hospitalized because this approach will detect nearly all postoperative delirium. Observed daytime delirium will be recorded and considered as an outcome. Delirium will not be evaluated the evening after surgery because confusion might result from residual anesthetic effects.
Measured: from postoperative day 1 throughout postoperative day 5
Postoperative cognitive decline
Postoperative cognitive decline (assessed using 30-points MoCA 7.1 version). The validated Chinese version will be used.
MoCA evaluates multiple cognitive domains including executive function and is widely used. Validated versions of MoCA are available in many languages including Chinese and German. A decrease of ≥2 points is associated with cognitive decline based on formal neuropsychological testing and considered a clinically meaningful reduction.
Measured: Assessed before surgery, on postoperative day 5 and 30
Length of hospital stay
Length of hospital stay in days
Measured: from the day of surgery (day 0) until hospital discharge or until day 30, whichever occurs first
Perioperative stroke
Any stroke per current clinical diagnostic criteria arising during surgery or after surgery until postoperative day 30.
Measured: Stroke will be assessed from the day of surgery throughout postoperative day 30
Cardiac complications (one component of the primary outcome)
Cardiac complications include:
- non-fatal cardiac arrest (An absence of cardiac rhythm or presence of chaotic rhythm requiring any component of basic or advanced cardiac life support.)
- myocardial injury (Myocardial injury is defined as any myocardial infarction (i.e., 4th Universal Definition of myocardial infarction32), or any elevated troponin judged to be due to myocardial ischemia (i.e. without evidence of a non-ischemic etiology, e.g. chronic elevation, pulmonary embolism, sepsis, cardioversion, others) that occurred with the first 30 days after surgery.)
- heart failure (per current standard diagnostic criteria.)
- new-onset symptomatic ventricular arrhythmia (per current standard diagnostic criteria.)
Measured: from the day of surgery (i.e., day 0) until postoperative day 30 for a total of 31 days
Respiratory failure (one component of the primary outcome)
Respiratory failure is defined as the requirement of respiratory support (intubation, CPAP or BiPAP, or high-flow oxygen (>10 L/min)) for acute respiratory insufficiency for more than 6 hours after surgery.
Measured: from the day of surgery (i.e., day 0) until postoperative day 30 for a total of 31 days
Renal complications (one component of the primary outcome)
Renal complications in this study refers to acute Kidney Injury stages II and III diagnosed using the Kidney Disease Improving Global Guidelines (KDIGO).
Measured: from the postoperative day 1 until postoperative day 7 for a total of 7 days
Infectious complications (one component of the primary outcome)
Infectious complications include the following:
- Surgical site infection (deep surgical site):
- Surgical site infection (organ/space)
- Pneumonia
- Laboratory confirmed bloodstream infection
- Infection, source uncertain
- Sepsis Sepsis will be diagnosed per the Third International Consensus Definitions.38,39 The Task Force defines sepsis as a "life-threatening organ dysfunction due to a dysregulated host response to infection." Clinical diagnosis of organ dysfunction requires a two-point increase in the Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score, starting the day after surgery and continuing throughout hospitalization as shown below (adopted from Singer38).
Measured: from postoperative day 1 until postoperative day 30 for a total of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start8 Jun 2021
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain Ischemia HypoxiaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,960 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Chest Hospital
- Responsible party
- Sponsor
- Investigators
- Jiange Han, Principal investigator, Tianjin Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896736
- Sponsor's protocol ID
- 2021KY-008-01
- Other IDs
- 000
- Acronym
- BOTTOMLINECS
- Status last verified
- Mar 2024
- First submitted
- 26 Apr 2021
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will only be available to journals for audits or authorities required by law.
Publications
Li G, Tian DD, Wang X, Feng X, Zhang W, Bao J, Wang DX, Ai YQ, Liu Y, Zhang M, Xu M, Mu DL, Zhao X, Dai F, Yang JJ, Che X, Yanez D, Guo X, Meng L; iMODIPONV Research Group. Muscular Tissue Oxygen Saturation and Posthysterectomy Nausea and Vomiting: The iMODIPONV Randomized Controlled Trial. Anesthesiology. 2020 Aug;133(2):318-331. doi: 10.1097/ALN.0000000000003305.
PubMed 32667155Wang T, Zhang Z, Guo Z, Liu Z, Han J, Meng L. Adjusted Relationships between Mean Arterial Pressure, Cardiac Index, and Tissue Oxygenation during Off-pump Coronary Bypass. Anesthesiology. 2026 Nov 1;145(5):1145-1159. doi: 10.1097/ALN.0000000000006204. Epub 2026 Jun 15.
PubMed 42295102Han J, Zhai W, Wu Z, Zhang Z, Wang T, Ren M, Liu Z, Sessler DI, Guo Z, Meng L; Bottomline-CS investigation group. Care guided by tissue oxygenation and haemodynamic monitoring in off-pump coronary artery bypass grafting (Bottomline-CS): assessor blind, single centre, randomised controlled trial. BMJ. 2025 Mar 24;388:e082104. doi: 10.1136/bmj-2024-082104.
PubMed 40127893
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisite Tissue Oxygenation Guided Perioperative Care to Reduce Composite Complications in Cardiac Surgical Patients: the BOTTOMLINE-CS Trial
- ClinicalTrials.gov ID
- NCT04896736
- Acronym / sponsor ID
- BOTTOMLINECS / 2021KY-008-01
- Conditions
- Brain Ischemia Hypoxia, Muscle; Ischemic, Muscle Hypoxia
- Keywords
- Cerebral Tissue Oxygen Saturation, Muscular Tissue Oxygen Saturation, Cardiac Surgery, Complications, Multisite Tissue Oxygenation Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,960 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Tianjin Chest Hospital
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 21 May 2021 (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 BOTTOMLINE-CS trial is an international, open, single-center, pragmatic, randomised controlled trial to investigate whether multisite tissue oxygen saturation monitoring-guided perioperative care reduces composite complications within 30 days of randomization in off-pump coronary artery bypass grafting.
Detailed description
Short title: BOTTOMLINE-CS trial Methodology: International, open, single-center, pragmatic, randomised controlled trial Research sites: Tianjin Chest Hospital Objectives: To investigate whether multisite tissue oxygen saturation monitoring-guided perioperative care reduces composite complications within 30 days of randomization in off-pump coronary artery bypass grafting Number of patients: 1960 patients (980 per arm, two arms) Inclusion criteria: Patients aged ≥ 60 years undergoing elective off-pump coronary artery bypass grafting Exclusion criteria: Patient refusal, clinician refusal, preoperative requirement of respiratory support (intubation, CPAP or BiPAP, or high-flow oxygen (>10 L/min)), preoperative requirement of external cardiac assist devices, emergent or urgent surgery, patients expected to die within 30 days, current participation in another clinical trial Statistical analysis: Analyses will be performed on a modified intention-to-treat basis including all randomized patients who had undergone the scheduled surgery and had the record of the primary outcome. Summary statistics for each group, treatment effects, 95% confidence intervals, and p values will be presented for primary and secondary outcomes, and process measures. The primary outcome is a composite of complications arising within 30 days from randomization and will be analyzed using a logistic regression model.
Proposed start date: May 1, 2021 (First patient to be recruited) Proposed end date: April 30, 2023 (Last patient to be recruited) Study duration: 48 months (Starting from the first patient recruitment, spanning patient recruitment, data analysis, and manuscript writing and submission)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multisite tissue oxygenation monitoring-guided care | Experimental | Other: Multisite tissue oxygenation-guided careDetails are as follows. • Monitoring: SctO2 monitored using two probes placed on left and right forehead. SstO2 monitored using one probe placed over the forearm brachioradialis muscle on the arm not used for non-invasive blood pressure monitoring. • Baseline: The first baseline is measured 12-48 hours before surgery, with the patient supine, awake, calm, eyes closed, and breathing room air or oxygen that is equivalent to the home oxygen rate for patients using home oxygen. * Goals: Maintain both SctO2 and SstO2 within 90-110% of the baseline level. * Trigger of intervention: SctO2/SstO2 outside of the 90-110% baseline range. * Diagnosis: * Care team: The caregivers providing SctO2/SstO2-guided care will be trained and given the opportunity to use the intervention protocol in at least 20 patients before the formal study. * Treatments: Refer to the algorithm to restore SctO2/SstO2 within 90-110% baseline range. |
| Usual care | Active comparator | Other: Usual carePatients in the control group will be managed by clinical staff according to usual care. Patients in this group will be monitored using the same tissue oximeter used in the intervention group; however, the screen will be covered by an opaque cloth to prohibit the care givers seeing the monitoring data. The same baseline measurements will be performed in patients allocated to the usual care group. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged ≥ 60 years scheduled for elective off-pump CABG.
Key exclusion criteria (5 listed)
- Inability or refusal to provide consent of participation
- Preoperative requirement of respiratory support (intubation, CPAP or BiPAP, or high-flow oxygen (>10 L/min))
- Preoperative requirement of external cardiac assist device
- Urgent or emergent surgery
- Patients expected to die within 30 days of randomization
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 |
|---|---|---|
| Multisite tissue oxygenation-guided careThe following intervention algorithm is intended to be used as a guidance only. We emphasize the different aspects that can cause changes in SctO2/SstO2 in a systematic approach. We avoid recommending a concrete drug and method of dosing for a specific condition. Manage tissue perfusion Preload: overall picture including direct observation of the heart, findings of echocardiography, urine output, blood loss, labs results, HR, BP, PPV, SVV, fluid responsiveness (SV increase >/= 10% following 250 ml fluid bolus) Contractility: direct observation of the heart, findings of echocardiography Stroke volume and heart rate: important determinants of CO Systemic vascular resistance: important determinant of BP Regional vascular resistance: important determinant of tissue perfusion along with perfusion pressure Maintain autoregulation: normalize CO2, avoid potent vasodilators Manage arterial blood oxygen content Manage tissue metabolic activity | Other | Multisite tissue oxygenation monitoring-guided care |
| Usual careUsual care in this study means the standard perioperative care. Patients who are meant to receive usual care will receive both cerebral and muscular tissue oxygen saturation monitoring; however, the monitor screen will be covered and the monitoring data will not be used to guide clinical care. | Other | Usual care |
Primary outcome
Composite complication
Time frame: from the day of surgery (i.e., day 0) until postoperative day 30 for a total of 31 days (individual components may vary)
The primary outcome is a collapsed (one or more) composite of the following complications with a Clavien-Dindo grade II or greater arising within 30 days of randomization (randomization and surgery are performed on the same day). The patient is regarded as having the event of composite complications if any of the following complications occur (i.e., yes); otherwise, the patient is regarded as not having the event of composite complications. The percentage of patients having the event of composite complications will be used in the primary analysis. * Brain complications (delirium, cognition decline, stroke); * Cardiac complications (non-fatal cardiac arrest, myocardial injury, heart failure, new-onset symptomatic ventricular arrhythmia); * Respiratory failure; * Renal complications (AKI stages II and III); * Infectious complications; * Death.
9 secondary outcomes
Atrial fibrillation
Time frame: from the day of surgery until postoperative day 30
Postoperative delirium
Time frame: from postoperative day 1 throughout postoperative day 5
Postoperative cognitive decline
Time frame: Assessed before surgery, on postoperative day 5 and 30
Length of hospital stay
Time frame: from the day of surgery (day 0) until hospital discharge or until day 30, whichever occurs first
Perioperative stroke
Time frame: Stroke will be assessed from the day of surgery throughout postoperative day 30
Cardiac complications (one component of the primary outcome)
Time frame: from the day of surgery (i.e., day 0) until postoperative day 30 for a total of 31 days
Respiratory failure (one component of the primary outcome)
Time frame: from the day of surgery (i.e., day 0) until postoperative day 30 for a total of 31 days
Renal complications (one component of the primary outcome)
Time frame: from the postoperative day 1 until postoperative day 7 for a total of 7 days
Infectious complications (one component of the primary outcome)
Time frame: from postoperative day 1 until postoperative day 30 for a total of 30 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 Mar 2024.
- Background: PubMed 32667155Li G, Tian DD, Wang X, Feng X, Zhang W, Bao J, Wang DX, Ai YQ, Liu Y, Zhang M, Xu M, Mu DL, Zhao X, Dai F, Yang JJ, Che X, Yanez D, Guo X, Meng L; iMODIPONV Research Group. Muscular Tissue Oxygen Saturation and Posthysterectomy Nausea and Vomiting: The iMODIPONV Randomized Controlled Trial. Anesthesiology. 2020 Aug;133(2):318-331. doi: 10.1097/ALN.0000000000003305.
- Derived from this study: PubMed 42295102Wang T, Zhang Z, Guo Z, Liu Z, Han J, Meng L. Adjusted Relationships between Mean Arterial Pressure, Cardiac Index, and Tissue Oxygenation during Off-pump Coronary Bypass. Anesthesiology. 2026 Nov 1;145(5):1145-1159. doi: 10.1097/ALN.0000000000006204. Epub 2026 Jun 15.
- Derived from this study: PubMed 40127893Han J, Zhai W, Wu Z, Zhang Z, Wang T, Ren M, Liu Z, Sessler DI, Guo Z, Meng L; Bottomline-CS investigation group. Care guided by tissue oxygenation and haemodynamic monitoring in off-pump coronary artery bypass grafting (Bottomline-CS): assessor blind, single centre, randomised controlled trial. BMJ. 2025 Mar 24;388:e082104. doi: 10.1136/bmj-2024-082104.
- Individual participant dataSharing planned: No. The data will only be available to journals for audits or authorities required by law.
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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.
Jiange Han principal investigator
Tianjin Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multisite tissue oxygenation-guided care in people with Brain Ischemia Hypoxia and Muscle; Ischemic, run by Yale University at 1 site in China.
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 1 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: finished, as of the sponsor's last update on 25 Mar 2024. 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 China. 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?
Composite complication (time frame: from the day of surgery (i.e., day 0) until postoperative day 30 for a total of 31 days (individual components may vary)). 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 NCT04896736, which also lists 3 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 25 Mar 2024.