AKI - Acute Kidney InjuryPhase 2EASE-AKINCT07661940
Efficacy and Safety of SP16 in Preventing Acute Kidney Injury in At-risk Subjects With Chronic Kidney Disease Undergoing Elective Cardiac Surgery Using the Heart-lung-machine
A Phase 2 study testing SP16-3M in people with AKI - Acute Kidney Injury, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
This clinical study investigates the safety and potential effectiveness of the investigational drug SP16 in preventing acute kidney injury in patients with pre-existing chronic kidney disease who are undergoing cardiac surgery involving the use of cardiopulmonary bypass (heart-lung machine). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AKI - Acute Kidney Injury
- What is being tested?
- SP16-3M
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 14 Sep 2026to May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Individual aged ≥18 years.
- Male or female.
- Scheduled for CABG OR aortic valve surgery (aortic valve replacement or repair alone, with or without aortic root repair) OR mitral valve surgery OR aortic/mitral valve surgery combined with CABG.
- Use of the CPB during surgical intervention expected.
- Written informed consent obtained from the participant.
- Understanding of study procedures and willingness to abide by all procedures during the course of the clinical trial.
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- CKD Stage 2-3b with eGFR ≤90 and ≥30 ml/min/1.73 m2 (according to 2021 CKD-EPI equation) known for ≥ 3 months prior to enrollment
- BMI ≥19 kg/m² to ≤40 kg/m².
- Contraceptive measures:
- Female participants must fulfil at least one of the following criteria of highly effective contraception (according to CTFG recommendations v1.2) during and up to 3 months after the end of study participation:
- Menopause (at least 12 months of natural amenorrhoea or 6 months of amenorrhoea with serum FSH >40 mU/ml) OR
- Condition after bilateral ovariectomy or hysterectomy for at least 6 weeks prior to the screening appointment (Visit 1a, Day 54 to -2) OR
- Regular, correct and reliable use of a contraceptive method with an error rate ≤1% per year:
- Inhibition of ovulation by estrogen and progesterone combination preparations (oral, intravaginal, or transdermal) or
- Inhibition of ovulation by progesterone monopreparations (oral, per injectionem [depot injections], or implant) or
- Intrauterine device, hormone coil OR
- Bilateral tubal ligation OR
- Vasectomy of all partners OR
- Sexual abstinence.
- Male participants must fulfill at least one of the following contraceptive criteria during and up to 3 months after the end of participation in the study:
- Vasectomy OR
- Regular, correct, and reliable use of condoms
Who cannot join
- CKD stages 4-5 with eGFR <30 ml/min/1.73 m2 pre-surgery as determined by CKD EPI.
- Previous cardiac surgery.
- Person has a kidney transplant or another solid organ transplant.
- Person is scheduled for intermittent or continuous renal replacement therapy (dialysis).
- Known diagnosis of dementia or other clinical signs of mental illness that will prevent full understanding.
- Known diagnosis of severe COPD (Gold 3) and/or FEV1 < 1 l/s.
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- Heart failure with severity of symptoms according to NYHA IV.
- Heart failure with impaired cardiac pump function (LVEF <35%).
- Acute onset or ongoing sepsis - sepsis is defined as the presence of a confirmed or putative infection, along with a dysregulated systemic immune reaction leading to organ dysfunction.
- Clinical signs of a currently active infection including endocarditis requiring antibiotic treatment.
- Clinical signs of an acute viral infection.
- Serious underlying disease(s) or very poor general medical condition, so that in the investigator's judgment the person is not expected to survive ICU or hospital stay.
- Patient who has an active (requiring treatment) malignancy or history within 5 years prior to enrollment in the study, of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed.
- Administration of iodinated contrast agent within 24 hours prior to cardiac surgery
- Recent (discontinued in the last 14 days before V1a or V1b) or current treatment with immunosuppressive drugs, including, but not limited to, high dose corticosteroids [> 1 mg/kg of prednisone equivalent], tumour necrosis factor alpha blockers, or ciclosporin.
- Current regular use of anti inflammatory drugs such as NSAID, with discontinuation not possible. (however, if these medications are discontinued in the last 10 days before V2, the participant is eligible to participate). ASA up to 100 mg per day is allowed.
- Systemic corticosteroid therapy (any dose).
- Known active chronic inflammatory disease (including, but not limited to, rheumatoid arthritis or systemic lupus erythematosus).
- Known allergy to SP16 or to other ingredients of the IMP.
- Person who is not willing to use highly effective contraceptive measures (according to CTFG recommendations v1.2).
- Pregnant women.
- Breastfeeding women.
- Current participation in another interventional clinical study (register studies or non-interventional, observational studies excluded).
- Employee or direct relative of an employee of the study site, the CRO, or the Sponsor.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tilman Jobst-Schwan contact
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Mario Schiffer, +4991318539002, med4@uk-erlangen.de
Tilman Jobst-Schwan, med4@uk-erlangen.de
About this study
Official title: Efficacy and Safety of SP16 in Preventing Acute Kidney Injury in At-risk Subjects With Chronic Kidney Disease Undergoing Elective Cardiac Surgery Using the Heart-lung-machine: A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial (EASE-AKI)
This clinical study investigates the safety and potential effectiveness of the investigational drug SP16 in preventing acute kidney injury in patients with pre-existing chronic kidney disease who are undergoing cardiac surgery involving the use of cardiopulmonary bypass (heart-lung machine).
SP16 is an investigational medicinal product that has not yet been approved for clinical use. To date, it has been studied in 28 individuals. The sponsor aims to evaluate whether SP16 can safely reduce or prevent kidney damage associated with the inflammatory and ischemia-reperfusion processes that may occur during cardiac surgery with cardiopulmonary bypass.
Read more
Participation in the study extends over a period of slightly more than five months. Screening procedures are performed within approximately seven weeks to two days before the scheduled surgery to determine eligibility for participation. During the hospitalization for cardiac surgery, which is expected to last approximately 10 days, a total of 11 study visits are conducted. Follow-up assessments include a telephone contact approximately one month after hospital discharge and a final on-site study visit approximately three months after discharge.
This is a randomized, double-blind, placebo-controlled clinical trial. Participants are randomly assigned to receive either SP16 or a placebo, which contains no active ingredient. Neither the participants nor the investigators know which treatment has been assigned during the study period.
Based on previous preclinical and early clinical findings, SP16 may have the potential to reduce or mitigate kidney injury caused by the use of the heart-lung machine during cardiac surgery. However, since the efficacy of SP16 has not yet been proven, no clinical benefit can be guaranteed. Participants receiving placebo are not expected to derive a direct therapeutic benefit from study treatment.
- Conditions
- AKI - Acute Kidney Injury
- Being tested
- SP16-3M, Placebo
- Keywords
- AKI, cardiac surgery, CKD
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP16-3MDrug
The IMP is injected subcutaneously at two different time points. The first administration will take place pre-surgically, in the area of the operating theatre, when the participant is under anesthesia. The second administration will be performed post-surgically, 9±1 h after the first administration.
At each of the two injection timepoints, a fixed dose of 6 mg SP16-3M is administered by two s.c. injections of 2 ml (concentration 1.5 mg/ml) each at two different injection sites.
PlaceboDrug
In the placebo group, placebo (dextrose 5%) is injected subcutaneously at the same timepoints as the IMP, each time slowly (over about 30 seconds) at a fixed volume of 2 ml each at two different injection sites.
| Study group | Role | What they receive |
|---|---|---|
| SP16-3M | Active comparator | Not described Receives: Drug: SP16-3M |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events (AEs) and severe adverse events (SAEs)
Frequency of adverse events (AEs) and severe adverse events (SAEs) will be assessed within 72 hours after index surgery and SP16 administration.
Measured: Within 72 hours after index surgery
Frequency of Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI)
Number of participants who develop CSA-AKI during hospital stay defined by Kidney Disease: Improving Global Outcomes [organization] (KDIGO) stage 1 or higher. If at least one of the following criteria is observed in the interval since end of index surgery and the 7-day assessment, a participant will be considered to have developed CSA-AKI:
- Increase in Serum Creatinine (SCr) by ≥0.3 mg/dl (>26.5 μmol/l) within 168±4 hours after index surgery (defined as the period since cardiopulmonary bypass [CPB] was terminated and systemic circulation resumed).
- Increase in SCr to ≥1.5 times the baseline value, using the highest SCr value within 168±4 hours after index surgery.
- Decrease in urine output <0.5 ml/kg/h for more than 6 hours within 168±4 h after index surgery
Measured: Within 7 days after index surgery
Secondary outcomes (14)
Severity of post-surgical CSA-AKI
Highest CSA-AKI stage value according to the stage classification of the KDIGO-AKI (https://kdigo.org) based on serum creatinine level (mg/dl) and urinary output (ml/kg/hour) in the 7-day period after the index surgery:
Stage 1: serum creatinine level 1.5 to 1.9 times baseline within 7 d OR
≥ 0.3 mg/dl (≥ 26.5 μmol/l) increase within 48 h; urine output < 0.5 ml/kg/h for 6 h Stage 2: serum creatinine level 2.0 - 2.9 times baseline within 7 d; urine output < 0.5 ml/kg/h for ≥ 12 h Stage 3: serum creatinine level 3.0 times baseline OR increase to ≥ 4.0 mg/dl OR Initiation of renal replacement therapy within 7 d; urine output < 0.3 ml/kg/h for ≥ 24 h OR anuria for ≥ 12 h
Measured: Within 7 days after index surgery
Duration of post-surgical CSA-AKI
Number of days after post-surgical onset of CSA-AKI until re-achievement of baseline level of serum creatinine (defined as a return of creatinine to <0.3 mg/dl above baseline value) or discharge from hospital, whichever comes first.
Measured: From the timepount of index surgery to the end of surveillance 90±7 days after index surgery
Necessity of renal replacement therapy (RRT)
The frequency of RRT post-surgery will be recorded.
Measured: From the timepoint of index surgery to the end of surveillance 90±7 days after index surgery
Duration of renal replacement therapy (RRT)
Duration of RRT measured by starting date [yyyy-mmm-dd] and end date [yyyy-mmm-dd]
Measured: From the timepoint of index surgery to the end of surveillance 90±7 days after index surgery
Cardiac function on Day 90±7 days after cardiac index surgery
Cardiac function on Day 90±7 days after cardiac index surgery compared to pre surgical assessment (Visit 1) assessed by transthoracic echocardiography (TTE).
Measured: At the end of surveillance 90±7 days after index surgery
Cardiac function on Day 0 post-surgery (Visit 3), Day 1, and on Day 5 after index surgery
Cardiac function on Day 0 post-surgery (Visit 3), Day 1, and on Day 5 after index surgery assessed by point of care echocardiography (TTE) compared to pre-surgical assessment (Visit 1).
Measured: Within 5 days after index surgery
Concentration of NT-proBNP (serum)
NT-proBNP serum concentration on Day 1, Day 7, and Day 90±7 after index surgery compared to pre-surgical assessment on Day 0 (Baseline; Visit 2).
Measured: From enrollment to the end of surveillance 90±7 days after index surgery
Central venous oxygen saturation (ScvO2) (blood gas analysis)
Central venous oxygen saturation (ScvO2) on Day 1, Day 5 and Day 7 after index surgery compared to pre-surgical assessment on Day 0 (Baseline; Visit 2).
Measured: Within 7 days after surgery
Frequency of all-cause death
Frequency of all-cause death within 90±7 days (3 months) after cardiac index surgery.
Measured: From the timepopint of index surgery to the end of surveillance 90±7 days after index surgery
Frequency of sustained impaired renal function
Frequency of sustained impaired renal function defined as ≥25% increase in Serum Creatinine at Day 90±7 compared to baseline.
Measured: From the timepopint of index surgery to the end of surveillance 90±7 days after index surgery
Frequency of sustained impaired renal function requiring at least one dialysis
Frequency of sustained impaired renal function requiring at least one dialysis during the post-surgical interval until Day 90±7 (end of observation period).
Measured: From enrollment to the end of surveillance 90±7 days after index surgery.
Frequency of AE and SAE within 7 days after cardiac index surgery.
The incidence of adverse events (AEs) and severe adverse events (SAEs) will be assessed in detail in addition to the primary outcome measure within 7 days after cardiac index surgery.
Measured: Within 7 days after index surgery
Frequency of AE and SAE during the observation period.
Frequency of AE and SAE during the entire observation period.
Measured: From enrollment to the end of surveillance after 90±7 days after index surgery.
Number of participants with at least one SAE
Number of participants with at least one SAE during the observation period.
Measured: From the first timepoint of SP16 administration to the end of surveillance 90±7 days after index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start14 Sep 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKI - Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Serpin Pharma, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661940
- Sponsor's protocol ID
- 0740
- Other IDs
- 2025-522491-89-00, 2025
- Acronym
- EASE-AKI
- Status last verified
- Feb 2026
- First submitted
- 21 May 2026
- Last updated
- 24 Sep 2026
- 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of SP16 in Preventing Acute Kidney Injury in At-risk Subjects With Chronic Kidney Disease Undergoing Elective Cardiac Surgery Using the Heart-lung-machine: A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial (EASE-AKI)
- ClinicalTrials.gov ID
- NCT07661940
- Acronym / sponsor ID
- EASE-AKI / 0740
- Conditions
- AKI - Acute Kidney Injury
- Keywords
- AKI, cardiac surgery, CKD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Serpin Pharma, LLC
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 22 Jun 2026 (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 clinical study investigates the safety and potential effectiveness of the investigational drug SP16 in preventing acute kidney injury in patients with pre-existing chronic kidney disease who are undergoing cardiac surgery involving the use of cardiopulmonary bypass (heart-lung machine).
SP16 is an investigational medicinal product that has not yet been approved for clinical use. To date, it has been studied in 28 individuals. The sponsor aims to evaluate whether SP16 can safely reduce or prevent kidney damage associated with the inflammatory and ischemia-reperfusion processes that may occur during cardiac surgery with cardiopulmonary bypass.
Participation in the study extends over a period of slightly more than five months. Screening procedures are performed within approximately seven weeks to two days before the scheduled surgery to determine eligibility for participation. During the hospitalization for cardiac surgery, which is expected to last approximately 10 days, a total of 11 study visits are conducted. Follow-up assessments include a telephone contact approximately one month after hospital discharge and a final on-site study visit approximately three months after discharge.
This is a randomized, double-blind, placebo-controlled clinical trial. Participants are randomly assigned to receive either SP16 or a placebo, which contains no active ingredient. Neither the participants nor the investigators know which treatment has been assigned during the study period.
Based on previous preclinical and early clinical findings, SP16 may have the potential to reduce or mitigate kidney injury caused by the use of the heart-lung machine during cardiac surgery. However, since the efficacy of SP16 has not yet been proven, no clinical benefit can be guaranteed. Participants receiving placebo are not expected to derive a direct therapeutic benefit from study treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SP16-3M | Active comparator | Drug: SP16-3M |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Individual aged ≥18 years.
- Male or female.
- Scheduled for CABG OR aortic valve surgery (aortic valve replacement or repair alone, with or without aortic root repair) OR mitral valve surgery OR aortic/mitral valve surgery combined with CABG.
- Use of the CPB during surgical intervention expected.
- Written informed consent obtained from the participant.
Key exclusion criteria (24 listed)
- CKD stages 4-5 with eGFR <30 ml/min/1.73 m2 pre-surgery as determined by CKD EPI.
- Previous cardiac surgery.
- Person has a kidney transplant or another solid organ transplant.
- Person is scheduled for intermittent or continuous renal replacement therapy (dialysis).
- Known diagnosis of dementia or other clinical signs of mental illness that will prevent full understanding.
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 |
|---|---|---|
| SP16-3MThe IMP is injected subcutaneously at two different time points. The first administration will take place pre-surgically, in the area of the operating theatre, when the participant is under anesthesia. The second administration will be performed post-surgically, 9±1 h after the first administration. At each of the two injection timepoints, a fixed dose of 6 mg SP16-3M is administered by two s.c. injections of 2 ml (concentration 1.5 mg/ml) each at two different injection sites. | Drug | SP16-3M |
| PlaceboIn the placebo group, placebo (dextrose 5%) is injected subcutaneously at the same timepoints as the IMP, each time slowly (over about 30 seconds) at a fixed volume of 2 ml each at two different injection sites. | Drug | Placebo |
Primary outcome
Frequency of adverse events (AEs) and severe adverse events (SAEs)
Time frame: Within 72 hours after index surgery
Frequency of adverse events (AEs) and severe adverse events (SAEs) will be assessed within 72 hours after index surgery and SP16 administration.
Frequency of Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI)
Time frame: Within 7 days after index surgery
Number of participants who develop CSA-AKI during hospital stay defined by Kidney Disease: Improving Global Outcomes [organization] (KDIGO) stage 1 or higher. If at least one of the following criteria is observed in the interval since end of index surgery and the 7-day assessment, a participant will be considered to have developed CSA-AKI: * Increase in Serum Creatinine (SCr) by ≥0.3 mg/dl (>26.5 μmol/l) within 168±4 hours after index surgery (defined as the period since cardiopulmonary bypass [CPB] was terminated and systemic circulation resumed). * Increase in SCr to ≥1.5 times the baseline value, using the highest SCr value within 168±4 hours after index surgery. * Decrease in urine output <0.5 ml/kg/h for more than 6 hours within 168±4 h after index surgery
14 secondary outcomes
Severity of post-surgical CSA-AKI
Time frame: Within 7 days after index surgery
Duration of post-surgical CSA-AKI
Time frame: From the timepount of index surgery to the end of surveillance 90±7 days after index surgery
Necessity of renal replacement therapy (RRT)
Time frame: From the timepoint of index surgery to the end of surveillance 90±7 days after index surgery
Duration of renal replacement therapy (RRT)
Time frame: From the timepoint of index surgery to the end of surveillance 90±7 days after index surgery
Cardiac function on Day 90±7 days after cardiac index surgery
Time frame: At the end of surveillance 90±7 days after index surgery
Cardiac function on Day 0 post-surgery (Visit 3), Day 1, and on Day 5 after index surgery
Time frame: Within 5 days after index surgery
Concentration of NT-proBNP (serum)
Time frame: From enrollment to the end of surveillance 90±7 days after index surgery
Central venous oxygen saturation (ScvO2) (blood gas analysis)
Time frame: Within 7 days after surgery
Frequency of all-cause death
Time frame: From the timepopint of index surgery to the end of surveillance 90±7 days after index surgery
Frequency of sustained impaired renal function
Time frame: From the timepopint of index surgery to the end of surveillance 90±7 days after index surgery
Frequency of sustained impaired renal function requiring at least one dialysis
Time frame: From enrollment to the end of surveillance 90±7 days after index surgery.
Frequency of AE and SAE within 7 days after cardiac index surgery.
Time frame: Within 7 days after index surgery
Frequency of AE and SAE during the observation period.
Time frame: From enrollment to the end of surveillance after 90±7 days after index surgery.
Number of participants with at least one SAE
Time frame: From the first timepoint of SP16 administration to the end of surveillance 90±7 days after index surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Approved study protocol by the European Medicines Agency (EMA)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Tilman Jobst-Schwan contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SP16-3M in people with AKI - Acute Kidney Injury, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Schiffer (+4991318539002, med4@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of adverse events (AEs) and severe adverse events (SAEs) (time frame: Within 72 hours after index surgery). 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 24 Sep 2026.