Acute on Chronic Systolic Congestive Heart FailureNEUTRALIZE-CRSNCT03836482
Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD
A study testing Selective Cytopheretic Device in people with Acute on Chronic Systolic Congestive Heart Failure and Cardiorenal Syndrome, run by SeaStar Medical at 1 site in United States.
Trial summary
Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system but also the renal, neuroendocrine, and immune systems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute on Chronic Systolic Congestive Heart Failure, Cardiorenal Syndrome
- What is being tested?
- Selective Cytopheretic Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2025to Aug 2027
- Phase
- Interventional
- 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
- Age of 18 years and older.
- Evidence of systemic inflammation: blood CRP ≥ 4.5 mg/L or IL-6 ≥ 5.0 pg/ml or neutrophil to lymphocyte ratio ≥3.0.
- Primary hospitalization for acute decompensated chronic systolic heart failure.
- Potential LVAD candidate with:
- Left ventricular ejection fraction ≤25% (for potential destination therapy) or ≤ 35% (for potential bridge to transplantation) as confirmed by baseline imaging procedure b) NYHA class IIIB or IV chronic (≤ 90 days) systolic heart failure, with failure to respond to optimal medical therapy (beta blocker, ACE inhibitor or ARB or valsartan/sacubitril, aldosterone antagonist, SGLT2i, unless not tolerated or contraindicated, and loop diuretic, as needed) for 45 of the last 60 days c) Known previous peak exercise oxygen consumption < 14 mL/Kg/min or if unable to exercise, dependent on an intra-aortic balloon pump, short-term mechanical circulatory support device or intravenous inotropes unless inotropes contraindicated for clinical reasons (e.g., ventricular arrhythmias)
- Baseline eGFR** ≥ 40 ml/min/1.73 m2 (baseline defined as the highest known eGFR within 90 days of study enrollment)
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- At least one of the following two criteria:
- Severe right ventricular failure (RVF), defined as meeting at least 2 of the following 4 criteria -Central venous pressure > 16 mmHg
- -Central venous pressure/Pulmonary wedge pressure >0.65
- -Right ventricular stroke work index < 300 mmHg ml/m2
- -Pulmonary artery pulsatility index (PAPi) < 2,
- Worsening renal failure (WRF), defined for the purposes of this study as -Increase serum creatinine ≥ 0.5 mg/dL from baseline (baseline defined as the lowest known serum creatinine within 90 days of study enrollment) AND
- eGFR ≤ 30 ml/min/1.73 m2 based on serum creatinine at enrollment* AND
- Cardiorenal syndrome is the most likely explanation for WRF AND
- Intolerant or inadequately responsive to standard of care diuretic therapy, defined as persistent signs and/or symptoms of congestion (e.g., peripheral edema, dyspnea, pulmonary rales, neck vein distension) or minimal net volume removal in a 24-hour period despite optimal medical therapy including intravenous diuretic therapy and an estimated need for >5kg fluid removal.
- Optimal intravenous diuretic therapy is defined as:
- Furosemide equivalent total daily dose of 240mg
- Furosemide equivalent dose given either as a single or multiple intravenous bolus or continuous infusion
- A furosemide equivalent total daily dose <240mg if the dose has resulted in >3000 mL urine output/24 hours.
- PA catheter in place at the time of enrollment
- PCW ≥ 20 mmHg
- eGFR calculated using the CKD-EPI Creatinine Equation *** Recognizing that this is not a steady state creatinine
Who cannot join
- Any clear contraindication to LVAD therapy that is unlikely to resolve with improvement in renal function and volume status
- Prior sensitivity to dialysis device components
- Active bacteremia
- Temperature ≥ 101.5 F or WBC ≥ 10,000 K/uL or any patient with suspected systemic infection.
- Metastatic malignancy requiring palliative chemo, biologic, or radiation
- Need for intravenous vasopressor (i.e., phenylephrine, vasopressin), intravenous vasoconstricting inotrope (i.e., norepinephrine or epinephrine) or dopamine > 3 mcg/kg/min. (Note: use of vasodilating inotropes [i.e., dobutamine and milrinone] or dopamine at ≤ 3 mcg/kg/min will not preclude study inclusion)
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- Patients requiring mechanical ventilatory support
- Patients requiring total parenteral nutrition during the treatment period
- Persistent SBP < 80 mmHg
- WBC < 4000 K/uL
- Platelets < 100,000K/uL
- Serum creatinine > 4 mg/dL or receiving dialysis / CRRT
- Acute coronary syndrome within the past month
- Women who are pregnant, breastfeeding a child, or trying to become pregnant
- Concurrent enrollment in another interventional clinical trial. Patients enrolled in clinical studies where only measurements and/or samples are taken (i.e., no test device or test drug used) are allowed to participate
- Use of any other investigational drug or device within the previous 30 days. Patients who participated in a clinical study where only measurements and/or samples are taken (i.e., no test device or drug used) are allowed to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Abbas Bitar, MD, 317-554-7788
About this study
Official title: Feasibility Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) to Treat ICU Patients With Acute on Chronic Systolic Heart Failure With Worsening Renal Function Due to Cardiorenal Syndrome or Severe Right Ventricular Failure Awaiting Left Ventricular Assist Device Implantation
Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system but also the renal, neuroendocrine, and immune systems. No effective therapy is currently available to treat the most severe subset of CHF patients that have progressed to acute decompensated HF. An innovative approach to reduce the cardio-depressant effects associated with the chronic inflammatory state of CHF may provide a breakthrough for this disorder. This proposal will evaluate the safety and probable benefit to improve cardiac or renal function with an immunomodulatory device to bridge patients to Left Ventricular Assist Device (LVAD) implantation who were previously deemed ineligible for this life sustaining procedure. The Selective Cytopheretic Device (SCD) is an immuno-regulating, extracorporeal membrane device targeted to modulate the cardiodepressant effects assocaited with CHF. SCD is a platform technology focused on immunomodulation of acute and chronic inflammation associated with acute and chronic organ dysfunction. SCD membranes selectively sequester activated systemic leukocytes as they flow through the cartridge via an extracorporeal circuit. Pre-clinical results show that SCD treatment results in a 25% improvement in ejection fraction in a canine CHF model.
This study will enroll 20 patients across up to 5 clinical sites to evaluate the safety and initial efficacy data of SCD treatment in this indication. Patients will receive 4-hour daily SCD treatment for up to 6 days, followed by 6 months of follow up.
- Being tested
- Selective Cytopheretic Device
- Keywords
- Awaiting Left ventricular assist device implantation, Hospitalized, Selective Cytopheretic Device, SCD, LVAD, CRS
- Medical subject headings
- Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Cytopheretic DeviceDevice
Treatment will be delivered for 4 hours a day for up to 6 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Selective Cytopheretic Device | Experimental | Not described Receives: Device: Selective Cytopheretic Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for continuous IV vasopressor support
Need for continuous IV vasopressor support with >5 total norepinephrine equivalents and/or >3 vasopressor agents >4 hours following termination of daily SCD therapy session to maintain a MAP >60 mmHg, with norepinephrine equivalents defined as:
- 1 x epinephrine (ug/kg/min)
- 001 x dopamine (ug/kg/min)
- 0.06 x phenylephrine (ug/kg/min)
- 2.5 x vasopressin (U/min) (Note that use of inotropes (i.e., dobutamine and milrinone) or dopamine at ≤3 mcg/kg/min are not components of this measure.)
Measured: measured daily, at or after 4 hours after termination of daily SCD therapy
Acute myocardial infarction
Acute myocardial infarction as evidenced by elevated cardiac enzymes, with electrocardiographic or imaging findings consistent with myocardial damage and confirmed by Cardiology.
Measured: up to 6 months following SCD treatment initiation
Mortality
Death
Measured: up to 6 months following SCD treatment initiation
Percentage of subjects with reversal of WRF and increase eGFR and PCW
Among patients with WRF, the percentage of subjects with reversal of WRF (≥ 0.5 mg/dL reduction of serum creatinine from level at study entry), and achieving an eGFR > 30 ml/min/1.73 m2 and PCWP at or below level at study entry at termination of SCD therapy.
Measured: up to 6 days after initiation of SCD therapy
Percentage of subjects who no longer have severe right ventricular failure
Among subjects with severe RVF, the percentage of subjects who no longer have severe right ventricular failure, as evidenced by absence of 3 or more of the following 4 indicators of right ventricular failure:
- CVP > 16 mmHg
- CVP/PCWP > 0.65
- RVSWI < 300 mmHg * mL/m
- PAPi < 2
Measured: up to 6 days after initiation of SCD therapy
Adverse Events
Adverse Events due to SCD, hemodialysis catheter, KRT pump, circuit, and hemofilter
Measured: up to 6 days after initiation of SCD therapy
Secondary outcomes (16)
Percentage of subject receiving a left ventricular assist device
Measured: up to 30 days after the last SCD
Change in 24 hour urine volume
Measured: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in urine sodium
Measured: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in urine creatinine
Measured: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in urine urea
Measured: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in creatinine clearance
Measured: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in urine urea clearance
Measured: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in Pulmonary Capillary Wedge Pressure (PCWP)
If PCWP cannot be obtained, Pulmonary Artery Diastolic Pressure (PADP) will be used in its place. When utilizing PADP in place of PCWP for change measures, comparisons will be made to baseline PADP.
Measured: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in serum sodium
Measured: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in serum potassium
Measured: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in serum dissolved carbon dioxide (CO2)
Measured: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in blood urea nitrogen (BUN)
Measured: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in serum creatinine
Measured: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Percentage of subjects with reduction of serum creatinine (≥ 0.5 mg/dL) and PCWP (≤ 18 mmHg)
If PCWP cannot be obtained, PADP will be used in its place. When utilizing PADP in place of PCWP for change measures, comparisons will be made to baseline PADP
Measured: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Percentage of subjects receiving a left ventricular assist device with serum creatinine ≥ 0.5 mg/dL below level at study entry
Measured: 30 days following discontinuation of SCD
Change in right ventricular fractional area change
Change in right ventricular fractional area change, TAPSE, and right ventricular global longitudinal strain
Measured: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start2 Oct 2025
- Primary completionFeb 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute on Chronic Systolic Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SeaStar Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Michigan, Innovative BioTherapies (IBT)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836482
- Sponsor's protocol ID
- SCD-CRS-01
- Other IDs
- 1R44HL170779-01A1
- Acronym
- NEUTRALIZE-CRS
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2019
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) to Treat ICU Patients With Acute on Chronic Systolic Heart Failure With Worsening Renal Function Due to Cardiorenal Syndrome or Severe Right Ventricular Failure Awaiting Left Ventricular Assist Device Implantation
- ClinicalTrials.gov ID
- NCT03836482
- Acronym / sponsor ID
- NEUTRALIZE-CRS / SCD-CRS-01
- Keywords
- Awaiting Left ventricular assist device implantation, Hospitalized, Selective Cytopheretic Device, SCD, LVAD, CRS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- SeaStar MedicalIndustry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Michigan, Innovative BioTherapies (IBT)
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 11 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.
Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system but also the renal, neuroendocrine, and immune systems. No effective therapy is currently available to treat the most severe subset of CHF patients that have progressed to acute decompensated HF. An innovative approach to reduce the cardio-depressant effects associated with the chronic inflammatory state of CHF may provide a breakthrough for this disorder. This proposal will evaluate the safety and probable benefit to improve cardiac or renal function with an immunomodulatory device to bridge patients to Left Ventricular Assist Device (LVAD) implantation who were previously deemed ineligible for this life sustaining procedure. The Selective Cytopheretic Device (SCD) is an immuno-regulating, extracorporeal membrane device targeted to modulate the cardiodepressant effects assocaited with CHF. SCD is a platform technology focused on immunomodulation of acute and chronic inflammation associated with acute and chronic organ dysfunction. SCD membranes selectively sequester activated systemic leukocytes as they flow through the cartridge via an extracorporeal circuit. Pre-clinical results show that SCD treatment results in a 25% improvement in ejection fraction in a canine CHF model.
This study will enroll 20 patients across up to 5 clinical sites to evaluate the safety and initial efficacy data of SCD treatment in this indication. Patients will receive 4-hour daily SCD treatment for up to 6 days, followed by 6 months of follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selective Cytopheretic Device | Experimental | Device: Selective Cytopheretic Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age of 18 years and older.
- Evidence of systemic inflammation: blood CRP ≥ 4.5 mg/L or IL-6 ≥ 5.0 pg/ml or neutrophil to lymphocyte ratio ≥3.0.
- Primary hospitalization for acute decompensated chronic systolic heart failure.
- Potential LVAD candidate with:
- Baseline eGFR** ≥ 40 ml/min/1.73 m2 (baseline defined as the highest known eGFR within 90 days of study enrollment)
Key exclusion criteria (16 listed)
- Any clear contraindication to LVAD therapy that is unlikely to resolve with improvement in renal function and volume status
- Prior sensitivity to dialysis device components
- Active bacteremia
- Temperature ≥ 101.5 F or WBC ≥ 10,000 K/uL or any patient with suspected systemic infection.
- Metastatic malignancy requiring palliative chemo, biologic, or radiation
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 |
|---|---|---|
| Selective Cytopheretic DeviceTreatment will be delivered for 4 hours a day for up to 6 consecutive days. | Device | Selective Cytopheretic Device |
Primary outcome
Need for continuous IV vasopressor support
Time frame: measured daily, at or after 4 hours after termination of daily SCD therapy
Need for continuous IV vasopressor support with >5 total norepinephrine equivalents and/or >3 vasopressor agents >4 hours following termination of daily SCD therapy session to maintain a MAP >60 mmHg, with norepinephrine equivalents defined as: 1. 1 x epinephrine (ug/kg/min) 2. 001 x dopamine (ug/kg/min) 3. 0.06 x phenylephrine (ug/kg/min) 4. 2.5 x vasopressin (U/min) (Note that use of inotropes (i.e., dobutamine and milrinone) or dopamine at ≤3 mcg/kg/min are not components of this measure.)
Acute myocardial infarction
Time frame: up to 6 months following SCD treatment initiation
Acute myocardial infarction as evidenced by elevated cardiac enzymes, with electrocardiographic or imaging findings consistent with myocardial damage and confirmed by Cardiology.
Mortality
Time frame: up to 6 months following SCD treatment initiation
Death
Percentage of subjects with reversal of WRF and increase eGFR and PCW
Time frame: up to 6 days after initiation of SCD therapy
Among patients with WRF, the percentage of subjects with reversal of WRF (≥ 0.5 mg/dL reduction of serum creatinine from level at study entry), and achieving an eGFR > 30 ml/min/1.73 m2 and PCWP at or below level at study entry at termination of SCD therapy.
Percentage of subjects who no longer have severe right ventricular failure
Time frame: up to 6 days after initiation of SCD therapy
Among subjects with severe RVF, the percentage of subjects who no longer have severe right ventricular failure, as evidenced by absence of 3 or more of the following 4 indicators of right ventricular failure: 1. CVP > 16 mmHg 2. CVP/PCWP > 0.65 3. RVSWI < 300 mmHg * mL/m 4. PAPi < 2
Adverse Events
Time frame: up to 6 days after initiation of SCD therapy
Adverse Events due to SCD, hemodialysis catheter, KRT pump, circuit, and hemofilter
16 secondary outcomes
Percentage of subject receiving a left ventricular assist device
Time frame: up to 30 days after the last SCD
Change in 24 hour urine volume
Time frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in urine sodium
Time frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in urine creatinine
Time frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in urine urea
Time frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in creatinine clearance
Time frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in urine urea clearance
Time frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in Pulmonary Capillary Wedge Pressure (PCWP)
Time frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in serum sodium
Time frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in serum potassium
Time frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in serum dissolved carbon dioxide (CO2)
Time frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in blood urea nitrogen (BUN)
Time frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Change in serum creatinine
Time frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Percentage of subjects with reduction of serum creatinine (≥ 0.5 mg/dL) and PCWP (≤ 18 mmHg)
Time frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
Percentage of subjects receiving a left ventricular assist device with serum creatinine ≥ 0.5 mg/dL below level at study entry
Time frame: 30 days following discontinuation of SCD
Change in right ventricular fractional area change
Time frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation
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 31 Mar 2026.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective Cytopheretic Device in people with Acute on Chronic Systolic Congestive Heart Failure and Cardiorenal Syndrome, run by SeaStar Medical at 1 site in United States.
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 16 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 31 Mar 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 United States. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for continuous IV vasopressor support (time frame: measured daily, at or after 4 hours after termination of daily SCD therapy). The study lists 6 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 31 Mar 2026.