Aneurysmal Subarachnoid HemorrhageHASHNCT06548477
Human Albumin for Clinical Outcome in Aneurysmal Subarachnoid Hemorrhages
A study testing Human albumin in people with Aneurysmal Subarachnoid Hemorrhage, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
Aneurysmal subarachnoid hemorrhage (aSAH) is a dreadful acute neurological condition with overwhelmingly high rate of associated morbidities and mortality. Despite leaping advancement in neurosurgical techniques and imaging modalities, there is no substantiative improvement in overall prognosis for aSAH. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Human albumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteQatar
- Study dates
- 1 Aug 2024to 31 Jul 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age limits of participants will be between 18 and 80 years with either gender (male or female).
- Clinical presentation with the first of symptom of aSAH must be within 72 hours before randomization.
- Clinical manifestation must be suggestive of aSAH that may include classical thunderclap headache, cranial nerve deficits, changes in level of consciousness, neck rigidity and neurological deficits.
- All cases with WFNS grade 1 to 5 (at the time of randomization) will be recruited in the study.
- Head computed tomography demonstrates evidence of SAH (graded on Claassen's scale).
- Diagnostic cerebral angiography shows a saccular aneurysm/s, consistent with clinical presentation of SAH.
- Definitive treatment of ruptured aneurysm/s (with clipping or coiling of combined) must be carried out within 72 hours prior to randomization.
- An informed consent by patient or surrogate representative, must be duly signed and dated.
Who cannot join
- Timing of first symptom of SAH cannot be reliably ascertained.
- Cerebral angiogram negative SAH.
- Cerebral angiography showing mycotic/traumatic/fusiform aneurysm/s.
- Symptomatic vasospasm or angiographic (on TCD or CTA) sets in before recruitment within 72 hours.
- History of clinical findings/hospitalization due to heart failure within the past 6 months,
- Albumin administration prior to randomization in the same hospital admission.
Show all 20Show fewer
- History of acute myocardial infarction (MI) within past 3 months.
- Any clinical presentations or electrocardiography (ECG) findings suggestive of acute MI on current admission.
- ECG evidence and/or clinical findings of 2nd or 3rd degree heart block or arrhythmias causing hemodynamic changes.
- Echocardiogram done before intervention/randomization showing an ejection fraction of <40%.
- A creatinine level of >2.0 mg/dl or a creatinine clearance of <50 ml/min
- Pregnancy, lactation, or parturition within previous 30 days
- Any allergies to any ingredient in human albumin preparation.
- A prior severe physical disability (mRS >2) that may hamper assessment of clinical outcome.
- Advanced chronic obstructive pulmonary diseases (with FEV1 <50%) may manifest as frequent episodes significantly affecting the overall quality of life.
- Hepatic failure or suspected liver dysfunction due to deranged liver functions, decreased serum albumin levels, high bilirubin levels with/without peripheral edema and hepatic encephalopathy.
- Patient has been already enrolled in another study involving a drug administration.
- Patient suffering from terminal diseases with life expectancy < 6 months
- If patient speaks any other language in which consent has not been translated.
- In case, patient drops out/withdraws from study or transferred out of state of Qatar and therefore lost to follow up short of 3-month follow up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qatar1 site, 1 recruiting
- Recruiting
Hamad General Hospital
Doha
Arshad, (+974) 44292799, AAli84@hamad.qa
Mohammad Mohsin Khan, (+974) 44392440, mmkyousafzai@gmail.com
About this study
Official title: Effectiveness of Human Albumin for Clinical Outcome in Aneurysmal Subarachnoid Hemorrhages: A Protocol for Randomized Controlled (Hash) Trial.
Aneurysmal subarachnoid hemorrhage (aSAH) is a dreadful acute neurological condition with overwhelmingly high rate of associated morbidities and mortality. Despite leaping advancement in neurosurgical techniques and imaging modalities, there is no substantiative improvement in overall prognosis for aSAH. Cerebral vasospasm remains the predominant cause of associated morbidities. Human albumin has been used in different neurological conditions including head trauma, intracerebral hemorrhages, and ischemic strokes with favorable outcome. However, its beneficial use in aSAH has not been sufficiently explored until recently a published systematic review by our team. In view of scarcity of published data and lack of robust evidence, our group has designed for the first ever RCT to compare the use human albumin-enhanced fluid management versus standard fluid therapy with crystalloids in patients with aSAH.
This single center open label, prospective, parallel group randomized control trial will be conducted at Hamad General Hospital, Doha-Qatar from August 2024 to July 2027. A sample size of 84 (42 in each arm) has been calculated to detect as sufficient to detect a clinically significant difference in modified Rankin Scale good score between two groups (human-albumin induced volume expansion therapy versus crystalloid only) for fluid management in aneurysmal subarachnoid hemorrhages patients. Primary outcome will be based on dichotomized modified Rankin scale [(Good grades (0-2) and poor grades (3-6)], while secondary outcome will include symptomatic vasospasm, transcranial doppler velocities, and Pulse Index Contour Cardiac Output (PiCCO) parameters.
The trial aims to provide firsthand evidence on the beneficial use of human albumin to achieve optimal fluid management regime to explore its potential role to improve clinical outcome in patients with aSAH.
Read the detailed description
Aneurysmal subarachnoid hemorrhage (aSAH) is a fatal neurosurgical emergency that may reach to a mortality of up to nearly 60% within one month of symptoms onset in untreated cases. Accounting for almost 5% of all stroke cases, aSAH predominantly affects the working age population with significant socioeconomic effect due to its impact on their quality of healthy life. Despite refined contemporary neurosurgical techniques and advancements in neurocritical care, secondary/delayed ischemia neurological deficits due to cerebral vasospasm, have been implicated as the main contributing factor, related to poor clinical outcome in nearly 30% of the patients. Although, over the years, many different treatment modalities have been used to counter the detrimental effects of vasospasm including calcium channel blockers and triple-H therapy (hypervolemic, hemodilution, hypertension) with no substantiative improvement in clinical outcome and a search for an effective management strategy continues.
In aSAH, hyponatremia due to increased release of natriuretic factors and reduction in intravascular volume have been attributed to cause clinical vasospasm and delayed ischemic neurological deficits as a part of natural course of the disease. Reduced cerebral blood flow during aSAH has been explained based on two etiological factors. Firstly, immediately with the clinical onset of aSAH, there is a generalized decrease in brain oxidative metabolism that contributes to drop in global cerebral blood flow (CBF). This disruption in brain metabolic harmony is primarily caused by presence of toxic blood products in subarachnoid spaces although other contributing factors including acute hydrocephalus, brain edema and rise in intracranial pressure may also play their roles to already compromised CBF. Secondly, during the course of subsequent days to weeks when cerebral vasospasm sets in, it can further cause drop in CBF and cerebral metabolism. This drop in CBF is topographically heterogenous in brain parenchyma and this manifests as the delayed cerebral ischemia causing neurological deficits. Based on these pathophysiological mechanisms, the standard use of hypervolemic therapy was rationalized in neurosurgical practice in the past to mitigate the detrimental effects of hypoperfusion and it used to be achieved by routine use of crystalloids/isotonic solutions and complementary colloidal agents including dextran, hypertonic saline and human albumin in neurocritical care.
In animal studies with rat models for acute focal ischemia, albumin treatment has effectively reduced size of penumbra. In contemporary clinical practice, the beneficial effects of human albumin has been investigated in cerebral strokes, acute brain injury, intracranial hemorrhages, including aSAH with promising results. In a pilot study conducted by Suarez et al (ALISAH) for a clinically safe dosage regimen for aSAH, it has also been observed that the use of albumin may be effective to prevent the deleterious effects of cerebral vasospasm by enhanced CBF leading to improvements in neurological outcome in aSAH patients. Ali A. et al recently published a systematic review that underscores obvious gaps in literature for the use of human albumin with no randomized control trial published to-date and highlighting the lack of any robust clinical evidence for the role of albumin to treat cerebral vasospasm in aSAH This single center RCT will aim to explore potential beneficial role of human albumin to improve clinical outcome in patients with aSAH.
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Being tested
- Human albumin
- Keywords
- HASH trial, Human Albumin, Subarachnoid hemorrhage, Aneurysmal, Effectiveness, Clinical Outcome, Protocol
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human albuminDrug
Patients in intervention arm will also receive intermittent boluses of 20 percent human albumin (in addition to standard fluid therapy) that will be administered with dosage regimen of 1.25gm/kg of body weight per 24 hours. The maximum total calculated dose/volume of albumin for the patient will be infused @ 34 ml/hour (over 3 hours) and will be divided in 3 boluses, spaced at 8 hours intervals. During intervention period, duration of treatment (7-day study period) will cover the peak period of cerebral vasospasm from day 4th until 10th day. Albumin administration will be tailored according to the targeted values set for euvolemic fluid balance in each patient. Before randomization (within 72 hours post-ictus) and after day-10 (from day 11th-14th, patient will only receive standard fluid therapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (Albumin group) | Experimental | Intervention group will receive of intermittent boluses of human albumin plus standard fluid therapy (with crystalloids only) to maintain a euvolemic fluid balance. Receives: Drug: Human albumin |
| Control (crystalloid group) | No intervention | Control group will receive only standard fluid therapy with crystalloid solutions with intermittent boluses crystalloid solution to maintain euvolemic balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dichomatized modified Rankin Scale (mRS)
Primary clinical outcome will be based on dichotomized modified Rankin Scale [(Good grades (0 -2) and poor grades (3-6)]. Primary outcome measures (values of mRS) will be compared between study arms to assess difference in the effect size of the intervention.
Measured: Endpoints for primary outcome measures (values of mRS) will be assessed on Day-14 and at 3 month follow up.
Secondary outcomes (1)
Development of Symptomatic vasospasm (with/without new onset infarctions on unenhanced Computed Tomography scan, transcranial doppler velocities (daily average) and PiCCO parameters (daily average values)
Secondary outcomes will include symptomatic vasospasm (with/without new onset infarctions on unenhanced Computed Tomography scan), transcranial doppler velocities (daily values), and all Pulse index Contour Cardiac Output (PiCCO) parameters (daily average values). On 14th day endpoint, a mean of all cumulative daily averaged values will be recorded for secondary outcome measures for; 1) the study period (4th-10th day) and 2) subsequently without albumin therapy (from day 11th -14th day) on Day-14 end-point. These secondary outcome measures will be compared between study arms to assess difference in the effect size of the intervention.
Measured: Endpoint for secondary outcome is at day-14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
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 Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe 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
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr Arshad Ali, Hamad Medical Corporation
- Investigators
- Arshad Ali, MBBS, MPH, FCPS, MSc, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548477
- Sponsor's protocol ID
- MR-01-24-229
- Acronym
- HASH
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ali A, Rajeswaran AB, Shaikh N, Al-Rumaihi G, Al-Sulaiti G. Role of albumin-induced volume expansion therapy for cerebral vasospasm in aneurysmal subarachnoid hemorrhage: A systematic review. J Neurosci Rural Pract. 2023 Oct-Dec;14(4):582-590. doi: 10.25259/JNRP_372_2023. Epub 2023 Oct 3.
PubMed 38059246Suarez JI, Shannon L, Zaidat OO, Suri MF, Singh G, Lynch G, Selman WR. Effect of human albumin administration on clinical outcome and hospital cost in patients with subarachnoid hemorrhage. J Neurosurg. 2004 Apr;100(4):585-90. doi: 10.3171/jns.2004.100.4.0585.
PubMed 15070109Ali A, Khan M, Shaikh N, Mohamad AE, Al-Maadhadi M, Shah N, Al-Najjar Y, Salam A, Al-Rumaihi G, Ayyad A, Belkhair S, Al-Sulaiti G. Effectiveness of human albumin for clinical outcome in aneurysmal subarachnoid hemorrhages: a protocol for randomized controlled (HASH) trial. Trials. 2025 Feb 14;26(1):53. doi: 10.1186/s13063-025-08762-5.
PubMed 39953562
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Human Albumin for Clinical Outcome in Aneurysmal Subarachnoid Hemorrhages: A Protocol for Randomized Controlled (Hash) Trial.
- ClinicalTrials.gov ID
- NCT06548477
- Acronym / sponsor ID
- HASH / MR-01-24-229
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Keywords
- HASH trial, Human Albumin, Subarachnoid hemorrhage, Aneurysmal, Effectiveness, Clinical Outcome, Protocol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 12 Aug 2024 (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.
Aneurysmal subarachnoid hemorrhage (aSAH) is a dreadful acute neurological condition with overwhelmingly high rate of associated morbidities and mortality. Despite leaping advancement in neurosurgical techniques and imaging modalities, there is no substantiative improvement in overall prognosis for aSAH. Cerebral vasospasm remains the predominant cause of associated morbidities. Human albumin has been used in different neurological conditions including head trauma, intracerebral hemorrhages, and ischemic strokes with favorable outcome. However, its beneficial use in aSAH has not been sufficiently explored until recently a published systematic review by our team. In view of scarcity of published data and lack of robust evidence, our group has designed for the first ever RCT to compare the use human albumin-enhanced fluid management versus standard fluid therapy with crystalloids in patients with aSAH.
This single center open label, prospective, parallel group randomized control trial will be conducted at Hamad General Hospital, Doha-Qatar from August 2024 to July 2027. A sample size of 84 (42 in each arm) has been calculated to detect as sufficient to detect a clinically significant difference in modified Rankin Scale good score between two groups (human-albumin induced volume expansion therapy versus crystalloid only) for fluid management in aneurysmal subarachnoid hemorrhages patients. Primary outcome will be based on dichotomized modified Rankin scale [(Good grades (0-2) and poor grades (3-6)], while secondary outcome will include symptomatic vasospasm, transcranial doppler velocities, and Pulse Index Contour Cardiac Output (PiCCO) parameters.
The trial aims to provide firsthand evidence on the beneficial use of human albumin to achieve optimal fluid management regime to explore its potential role to improve clinical outcome in patients with aSAH.
Detailed description
Aneurysmal subarachnoid hemorrhage (aSAH) is a fatal neurosurgical emergency that may reach to a mortality of up to nearly 60% within one month of symptoms onset in untreated cases. Accounting for almost 5% of all stroke cases, aSAH predominantly affects the working age population with significant socioeconomic effect due to its impact on their quality of healthy life. Despite refined contemporary neurosurgical techniques and advancements in neurocritical care, secondary/delayed ischemia neurological deficits due to cerebral vasospasm, have been implicated as the main contributing factor, related to poor clinical outcome in nearly 30% of the patients. Although, over the years, many different treatment modalities have been used to counter the detrimental effects of vasospasm including calcium channel blockers and triple-H therapy (hypervolemic, hemodilution, hypertension) with no substantiative improvement in clinical outcome and a search for an effective management strategy continues.
In aSAH, hyponatremia due to increased release of natriuretic factors and reduction in intravascular volume have been attributed to cause clinical vasospasm and delayed ischemic neurological deficits as a part of natural course of the disease. Reduced cerebral blood flow during aSAH has been explained based on two etiological factors. Firstly, immediately with the clinical onset of aSAH, there is a generalized decrease in brain oxidative metabolism that contributes to drop in global cerebral blood flow (CBF). This disruption in brain metabolic harmony is primarily caused by presence of toxic blood products in subarachnoid spaces although other contributing factors including acute hydrocephalus, brain edema and rise in intracranial pressure may also play their roles to already compromised CBF. Secondly, during the course of subsequent days to weeks when cerebral vasospasm sets in, it can further cause drop in CBF and cerebral metabolism. This drop in CBF is topographically heterogenous in brain parenchyma and this manifests as the delayed cerebral ischemia causing neurological deficits. Based on these pathophysiological mechanisms, the standard use of hypervolemic therapy was rationalized in neurosurgical practice in the past to mitigate the detrimental effects of hypoperfusion and it used to be achieved by routine use of crystalloids/isotonic solutions and complementary colloidal agents including dextran, hypertonic saline and human albumin in neurocritical care.
In animal studies with rat models for acute focal ischemia, albumin treatment has effectively reduced size of penumbra. In contemporary clinical practice, the beneficial effects of human albumin has been investigated in cerebral strokes, acute brain injury, intracranial hemorrhages, including aSAH with promising results. In a pilot study conducted by Suarez et al (ALISAH) for a clinically safe dosage regimen for aSAH, it has also been observed that the use of albumin may be effective to prevent the deleterious effects of cerebral vasospasm by enhanced CBF leading to improvements in neurological outcome in aSAH patients. Ali A. et al recently published a systematic review that underscores obvious gaps in literature for the use of human albumin with no randomized control trial published to-date and highlighting the lack of any robust clinical evidence for the role of albumin to treat cerebral vasospasm in aSAH This single center RCT will aim to explore potential beneficial role of human albumin to improve clinical outcome in patients with aSAH.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (Albumin group) | Experimental | Drug: Human albuminIntervention group will receive of intermittent boluses of human albumin plus standard fluid therapy (with crystalloids only) to maintain a euvolemic fluid balance. |
| Control (crystalloid group) | No intervention | –Control group will receive only standard fluid therapy with crystalloid solutions with intermittent boluses crystalloid solution to maintain euvolemic balance |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age limits of participants will be between 18 and 80 years with either gender (male or female).
- Clinical presentation with the first of symptom of aSAH must be within 72 hours before randomization.
- Clinical manifestation must be suggestive of aSAH that may include classical thunderclap headache, cranial nerve deficits, changes in level of consciousness, neck rigidity and neurological deficits.
- All cases with WFNS grade 1 to 5 (at the time of randomization) will be recruited in the study.
- Head computed tomography demonstrates evidence of SAH (graded on Claassen's scale).
Key exclusion criteria (20 listed)
- Timing of first symptom of SAH cannot be reliably ascertained.
- Cerebral angiogram negative SAH.
- Cerebral angiography showing mycotic/traumatic/fusiform aneurysm/s.
- Symptomatic vasospasm or angiographic (on TCD or CTA) sets in before recruitment within 72 hours.
- History of clinical findings/hospitalization due to heart failure within the past 6 months,
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 |
|---|---|---|
| Human albuminPatients in intervention arm will also receive intermittent boluses of 20 percent human albumin (in addition to standard fluid therapy) that will be administered with dosage regimen of 1.25gm/kg of body weight per 24 hours. The maximum total calculated dose/volume of albumin for the patient will be infused @ 34 ml/hour (over 3 hours) and will be divided in 3 boluses, spaced at 8 hours intervals. During intervention period, duration of treatment (7-day study period) will cover the peak period of cerebral vasospasm from day 4th until 10th day. Albumin administration will be tailored according to the targeted values set for euvolemic fluid balance in each patient. Before randomization (within 72 hours post-ictus) and after day-10 (from day 11th-14th, patient will only receive standard fluid therapy. | Drug | Intervention group (Albumin group) |
Primary outcome
Dichomatized modified Rankin Scale (mRS)
Time frame: Endpoints for primary outcome measures (values of mRS) will be assessed on Day-14 and at 3 month follow up.
Primary clinical outcome will be based on dichotomized modified Rankin Scale [(Good grades (0 -2) and poor grades (3-6)]. Primary outcome measures (values of mRS) will be compared between study arms to assess difference in the effect size of the intervention.
1 secondary outcome
Development of Symptomatic vasospasm (with/without new onset infarctions on unenhanced Computed Tomography scan, transcranial doppler velocities (daily average) and PiCCO parameters (daily average values)
Time frame: Endpoint for secondary outcome is at day-14.
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 12 Aug 2024.
- Background: PubMed 38059246Ali A, Rajeswaran AB, Shaikh N, Al-Rumaihi G, Al-Sulaiti G. Role of albumin-induced volume expansion therapy for cerebral vasospasm in aneurysmal subarachnoid hemorrhage: A systematic review. J Neurosci Rural Pract. 2023 Oct-Dec;14(4):582-590. doi: 10.25259/JNRP_372_2023. Epub 2023 Oct 3.
- Background: PubMed 15070109Suarez JI, Shannon L, Zaidat OO, Suri MF, Singh G, Lynch G, Selman WR. Effect of human albumin administration on clinical outcome and hospital cost in patients with subarachnoid hemorrhage. J Neurosurg. 2004 Apr;100(4):585-90. doi: 10.3171/jns.2004.100.4.0585.
- Derived from this study: PubMed 39953562Ali A, Khan M, Shaikh N, Mohamad AE, Al-Maadhadi M, Shah N, Al-Najjar Y, Salam A, Al-Rumaihi G, Ayyad A, Belkhair S, Al-Sulaiti G. Effectiveness of human albumin for clinical outcome in aneurysmal subarachnoid hemorrhages: a protocol for randomized controlled (HASH) trial. Trials. 2025 Feb 14;26(1):53. doi: 10.1186/s13063-025-08762-5.
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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.
Arshad Ali, MBBS, MPH, FCPS, MSc principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human albumin in people with Aneurysmal Subarachnoid Hemorrhage, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 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 12 Aug 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 Qatar. 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?
Contact Arshad Ali, MBBS, MPH, FCPS, MSc ((+974) 4439 2799, aali84@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dichomatized modified Rankin Scale (mRS) (time frame: Endpoints for primary outcome measures (values of mRS) will be assessed on Day-14 and at 3 month follow up.). 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 NCT06548477, 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 12 Aug 2024.