Acute Ischemic StrokePhase 1NCT06172387
Intra-arterial Albumin in Acute Ischemic Stroke After Endovascular Treatment for
A Phase 1 study testing intra-arterial infusion albumin and mechanical thrombectomy and a standard clinical therapy in people with Acute Ischemic Stroke, run by Tianjin Huanhu Hospital at 1 site in China.
Trial summary
Stroke is an acute focal injury of the central nervous system caused by cerebral vessels. One in every four people is affected by stroke at different times in life. Globally, stroke is the second leading cause of death and third leading cause of disability in adults. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- intra-arterial infusion albumin and mechanical thrombectomy and a standard clinical therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to Dec 2024
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Male or female, age≥18 and ≤ 80; 2. anterior circulation large vessel occlusion confirmed by CTA, MRA and DSA; 3. baseline National Institute of Health Stroke Scale (NIHSS) score ≥6； 4. Alberta Stroke Program Early CT Score (ASPECTS) 6-10; 5. Stroke symptoms present to femoral artery or brachial artery puncture within 24 hours； 6. occluded vessel reaches eTICI level ≥2b after thrombectomy confirmed by DSA；7. Informed consent obtained;
Who cannot join
- history of congestive heart failure or jugular dilatation, third heart sound, resting tachycardia due to heart failure (>100 beats/min), hepatomegaly and lower limb edema without obvious cause on admission physical examination; (2) hospitalization for acute myocardial infarction within 3 months; (3) symptoms of acute myocardial infarction or admission electrocardiogram; (4) second or third degree heart block or arrhythmia with hemodynamic instability; (5) acute or chronic renal failure (blood creatinine > 2.0 mg/dL); (6) severe anemia (hematocrit<32%); (7) symptoms or CT evidence of subarachnoid hemorrhage; (8) pregnancy; (9) allergy to albumin; (10) admission blood pressure higher than 185/110 mmHg; (11) any chronic lung disease, including chronic obstructive pulmonary disease, bronchiectasis, and other lung diseases that interfere with daily activities; (12) presence of other diseases that may endanger life.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Intra-arterial Albumin With Endovascular Treatment for Acute Ischemic Stroke : A Randomized, Controlled Pilot Study
Stroke is an acute focal injury of the central nervous system caused by cerebral vessels. One in every four people is affected by stroke at different times in life. Globally, stroke is the second leading cause of death and third leading cause of disability in adults. we hypothesized that in patients with acute large vessel occlusive ischemic stroke treated with mechanical thrombectomy, the infusion of 20% human serum albumin solution into the revascularization area can exert a stronger neuroprotective effect.
Read the detailed description
In the previous period, we have conducted a clinical trial on the safety and feasibility of arterial infusion of 20% human serum albumin solution. The results of the study found that after arterial infusion of 20% human serum albumin solution at a dose of 0.6g/kg to the subject's vascularization area, the subjects did not develop significant complications related to albumin solution. There were no serious adverse events associated with arterial infusion of albumin solution in all subjects. After the evaluation of the Data Safety Monitoring Board, the clinical study was considered to be the next step, which is to initially explore the effectiveness of 0.6g/kg arterial infusion of 20% human serum albumin solution for neuroprotection of subjects.
- Conditions
- Acute Ischemic Stroke
- Being tested
- intra-arterial infusion albumin, mechanical thrombectomy and a standard clinical therapy
- Keywords
- acute ischemic stroke, albumin, intra-arterial, thrombectomy, neuroprotection
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-arterial infusion albuminDrug
The experimental group would inject 20% human blood albumin solution into the responsible blood vessel supply area by catheter artery at a dose of 0.6g/kg. The infusion time is 20-30 minutes. All participant will receive mechanical thrombectomy and a standard clinical therapy.
mechanical thrombectomy and a standard clinical therapyOther
mechanical thrombectomy and a standard clinical therapy
| Study group | Role | What they receive |
|---|---|---|
| intra-arterial group | Experimental | 20% human serum albumin (0.6g/kg) solution will be injected into the artery after revascularization in acute ischemic stroke. All participants will receive mechanical thrombectomy and a standard clinical therapy. Receives: Drug: intra-arterial infusion albumin; Other: mechanical thrombectomy and a standard clinical therapy |
| sham group | Other | All participants have no intra-arterial albumin. Receives: Other: mechanical thrombectomy and a standard clinical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral infarct volume
infarct volume is evaluated mainly through brain MRI
Measured: 24-48 hours after randomization
Secondary outcomes (14)
modified Rankin Scale score(mRS)
the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
Measured: 90 ±10 days after randomization
the good prognosis at 90 days assessed by mRS
the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
Measured: 90 ±10 days after randomization
scores assessed by National Institutes of Health Stroke Scale (NIHSS)
the NIHSS is a stroke severity score that is composed of 11 items, range from 0 to 42, higher values indicate more severe deficits
Measured: 24 ± 6 hours, 48 ± 12 hours, 7 ± 2 days, 90 ±10 days after randomization
change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours
the NIHSS is a stroke severity score that is composed of 11 items, range from 0 to 42, higher values indicate more severe deficits
Measured: from baseline to 24 ± 6 hours
improvement of neurologic function after 24 hours
NIHSS score decreased by more than 4 points or NIHSS score was 0; secondary clinical efficacy endpoint; the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severs deficits)
Measured: 24 ± 6 hours after randomization
Barthel index (BI)
the BI is an ordinal disability score of 10 categories (range from 0-100, higher values indicate better prognosis)
Measured: 90 ±10 days after randomization
revascularization on follow-up imaging
secondary imaging efficacy endpoint
Measured: 24 (16 to 36) hours
24-hours neurologic deterioration
NIHSS score increased by more than 4 points; the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits); clinical safety endpoint
Measured: 24 ± 6 hours after randomization
any intracranial hemorrhage on follow-up imaging
imaging safety endpoints; per ECASSIII definition and per Heidelberg bleeding classification
Measured: 24 (12 to 36) hours
symptomatic intracerebral hemorrhage
imaging safety endpoints; deterioration in NIHSS score of ≥4 point within 24 hours;per ECASS III definition and per Heidelberg bleeding classification
Measured: 24 (12 to 36) hours
Mortality
clinical safety endpoint
Measured: 90 ± 10 days after randomization
Stroke recurrence
clinical safety endpoint
Measured: 90 ± 10 days after randomization
Survival rates
secondary clinical efficacy endpoint
Measured: 7 ± 2 days, 90 ± 10 days after randomization
mRS4-6
secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death)
Measured: 90 ± 10 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start1 Nov 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Huanhu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Wei, Tianjin Huanhu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172387
- Sponsor's protocol ID
- TJHH-2023-WM121
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 15 Dec 2023
- 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 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Intra-arterial Albumin With Endovascular Treatment for Acute Ischemic Stroke : A Randomized, Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06172387
- Acronym / sponsor ID
- TJHH-2023-WM121
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute ischemic stroke, albumin, intra-arterial, thrombectomy, neuroprotection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Tianjin Huanhu HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Dec 2023 (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.
Stroke is an acute focal injury of the central nervous system caused by cerebral vessels. One in every four people is affected by stroke at different times in life. Globally, stroke is the second leading cause of death and third leading cause of disability in adults. we hypothesized that in patients with acute large vessel occlusive ischemic stroke treated with mechanical thrombectomy, the infusion of 20% human serum albumin solution into the revascularization area can exert a stronger neuroprotective effect.
Detailed description
In the previous period, we have conducted a clinical trial on the safety and feasibility of arterial infusion of 20% human serum albumin solution. The results of the study found that after arterial infusion of 20% human serum albumin solution at a dose of 0.6g/kg to the subject's vascularization area, the subjects did not develop significant complications related to albumin solution. There were no serious adverse events associated with arterial infusion of albumin solution in all subjects. After the evaluation of the Data Safety Monitoring Board, the clinical study was considered to be the next step, which is to initially explore the effectiveness of 0.6g/kg arterial infusion of 20% human serum albumin solution for neuroprotection of subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intra-arterial group | Experimental | Drug: intra-arterial infusion albumin, Other: mechanical thrombectomy and a standard clinical therapy20% human serum albumin (0.6g/kg) solution will be injected into the artery after revascularization in acute ischemic stroke. All participants will receive mechanical thrombectomy and a standard clinical therapy. |
| sham group | Other | Other: mechanical thrombectomy and a standard clinical therapyAll participants have no intra-arterial albumin. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Male or female, age≥18 and ≤ 80; 2. anterior circulation large vessel occlusion confirmed by CTA, MRA and DSA; 3. baseline National Institute of Health Stroke Scale (NIHSS) score ≥6； 4. Alberta Stroke Program Early CT Score (ASPECTS) 6-10; 5. Stroke symptoms present to femoral artery or brachial artery puncture within 24 hours； 6. occluded vessel reaches eTICI level ≥2b after thrombectomy confirmed by DSA；7. Informed consent obtained;
Key exclusion criteria (1 listed)
- history of congestive heart failure or jugular dilatation, third heart sound, resting tachycardia due to heart failure (>100 beats/min), hepatomegaly and lower limb edema without obvious cause on admission physical examination; (2) hospitalization for acute myocardial infarction within 3 months; (3) symptoms of acute myocardial infarction or admission electrocardiogram; (4) second or third degree heart block or arrhythmia with hemodynamic instability; (5) acute or chronic renal failure (blood creatinine > 2.0 mg/dL); (6) severe anemia (hematocrit<32%); (7) symptoms or CT evidence of subarachnoid hemorrhage; (8) pregnancy; (9) allergy to albumin; (10) admission blood pressure higher than 185/110 mmHg; (11) any chronic lung disease, including chronic obstructive pulmonary disease, bronchiectasis, and other lung diseases that interfere with daily activities; (12) presence of other diseases that may endanger life.
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 |
|---|---|---|
| intra-arterial infusion albuminThe experimental group would inject 20% human blood albumin solution into the responsible blood vessel supply area by catheter artery at a dose of 0.6g/kg. The infusion time is 20-30 minutes. All participant will receive mechanical thrombectomy and a standard clinical therapy. | Drug | intra-arterial group |
| mechanical thrombectomy and a standard clinical therapymechanical thrombectomy and a standard clinical therapy | Other | intra-arterial group, sham group |
Primary outcome
cerebral infarct volume
Time frame: 24-48 hours after randomization
infarct volume is evaluated mainly through brain MRI
14 secondary outcomes
modified Rankin Scale score(mRS)
Time frame: 90 ±10 days after randomization
the good prognosis at 90 days assessed by mRS
Time frame: 90 ±10 days after randomization
scores assessed by National Institutes of Health Stroke Scale (NIHSS)
Time frame: 24 ± 6 hours, 48 ± 12 hours, 7 ± 2 days, 90 ±10 days after randomization
change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours
Time frame: from baseline to 24 ± 6 hours
improvement of neurologic function after 24 hours
Time frame: 24 ± 6 hours after randomization
Barthel index (BI)
Time frame: 90 ±10 days after randomization
revascularization on follow-up imaging
Time frame: 24 (16 to 36) hours
24-hours neurologic deterioration
Time frame: 24 ± 6 hours after randomization
any intracranial hemorrhage on follow-up imaging
Time frame: 24 (12 to 36) hours
symptomatic intracerebral hemorrhage
Time frame: 24 (12 to 36) hours
Mortality
Time frame: 90 ± 10 days after randomization
Stroke recurrence
Time frame: 90 ± 10 days after randomization
Survival rates
Time frame: 7 ± 2 days, 90 ± 10 days after randomization
mRS4-6
Time frame: 90 ± 10 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing intra-arterial infusion albumin and mechanical thrombectomy and a standard clinical therapy in people with Acute Ischemic Stroke, run by Tianjin Huanhu Hospital 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 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
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?
cerebral infarct volume (time frame: 24-48 hours after randomization). 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 15 Dec 2023.