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New treatment option for Aneurysmal Subarachnoid Hemorrhage
Official title Human Albumin for Clinical Outcome in Aneurysmal Subarachnoid Hemorrhages
ClinicalTrials.gov ID: NCT06548477
What this study is testing
What is Human albumin?
Human albumin is an investigational medicine, being studied as a potential treatment for aneurysmal subarachnoid hemorrhage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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).
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Doha, Qatar
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Doha, Qatar. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.