Status:
RECRUITING
Human Albumin for Clinical Outcome in Aneurysmal Subarachnoid Hemorrhages
Lead Sponsor:
Hamad Medical Corporation
Conditions:
Aneurysmal Subarachnoid Hemorrhage
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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...
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 alm...
Eligibility Criteria
Inclusion
- Inclusion 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.
- Exclusion criteria
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06548477
Start Date
August 1 2024
End Date
July 31 2027
Last Update
August 12 2024
Active Locations (1)
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1
Hamad General Hospital
Doha, Qatar