Role of albumin-induced volume expansion therapy for cerebral vasospasm in aneurysmal subarachnoid hemorrhage: A systematic review.
Arshad Ali, Arun Babu Rajeswaran, Nisar Shaikh...
https://pubmed.ncbi.nlm.nih.gov/38059246Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06548477
Effectiveness of Human Albumin for Clinical Outcome in Aneurysmal Subarachnoid Hemorrhages: A Protocol for Randomized Controlled Trial
Led by Hamad Medical Corporation · Updated on 2024-08-12
84
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Aneurysmal subarachnoid hemorrhage (aSAH) is a severe neurological emergency with high rates of disability and death. Despite advances in surgical techniques and imaging, outcomes remain poor, largely due to cerebral vasospasm causing delayed brain injury. This trial investigates whether using human albumin for fluid management can improve recovery compared to standard crystalloid fluids in patients with aSAH. Participants will be randomly assigned to receive either intermittent doses of 20% human albumin plus standard crystalloid fluids or standard crystalloid fluids alone to maintain normal fluid balance. Human albumin will be given as boluses totaling 1.25 g/kg per day over a 7-day treatment period covering the peak risk of vasospasm (days 4 to 10 after hemorrhage). Before treatment and after day 10, all patients receive standard fluid therapy. During the study, participants will be monitored through clinical assessments including the modified Rankin Scale at 14 days and 3 months to measure recovery. Secondary outcomes include observing symptomatic vasospasm, brain blood flow velocities via transcranial Doppler, and cardiac output parameters. The trial runs from August 2024 to July 2027 at a single center with follow-up lasting three months post-treatment.
CONDITIONS
Brief Title
Human Albumin for Clinical Outcome in Aneurysmal Subarachnoid Hemorrhages
Who Can Participate
Age: 18Years - 80Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years, any gender
- First symptom of aneurysmal subarachnoid hemorrhage within 72 hours before randomization
- Clinical signs consistent with aneurysmal subarachnoid hemorrhage such as thunderclap headache, neurological deficits, or neck stiffness
- World Federation of Neurosurgical Societies (WFNS) grade 1 to 5 at randomization
- Head CT scan shows evidence of subarachnoid hemorrhage
- Cerebral angiography confirms saccular aneurysm(s) matching clinical findings
- Ruptured aneurysm treated by clipping or coiling within 72 hours before randomization
- Signed informed consent by patient or legal representative
You will not qualify if you...
- Unclear timing of first subarachnoid hemorrhage symptom
- Negative cerebral angiogram for aneurysm
- Presence of mycotic, traumatic, or fusiform aneurysms
- Symptomatic or angiographic vasospasm before recruitment
- Heart failure hospitalization within past 6 months
- Prior albumin treatment during current hospital stay
- Acute myocardial infarction within past 3 months or signs on current admission
- Second or third degree heart block or arrhythmias affecting blood flow
- Echocardiogram showing ejection fraction below 40%
- Kidney failure with creatinine >2.0 mg/dl or clearance <50 ml/min
- Pregnancy, breastfeeding, or recent childbirth within 30 days
- Allergy to human albumin ingredients
- Severe disability (modified Rankin Scale >2) limiting outcome assessment
- Advanced lung disease with frequent severe episodes
- Liver failure or suspected liver dysfunction
- Participation in another drug study
- Terminal illness with life expectancy under 6 months
- Language barrier preventing informed consent
- Withdrawal or loss to follow-up before 3-month visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - Up to 72 hours before randomization
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - 7 days (from day 4 to day 10 post-ictus)
Participants receive intermittent boluses of human albumin plus standard fluid therapy or standard fluid therapy alone to maintain euvolemic fluid balance during the peak period of cerebral vasospasm.
Daily visits or monitoring during treatment period
Follow-up
Duration - Up to 3 months after treatment
Participants are monitored for clinical outcomes including neurological status and development of symptomatic vasospasm after treatment ends.
Visits at Day 14 and at 3 months post-treatment
Trial Site Locations
Total: 1 location
1
Hamad General Hospital
Doha, Qatar
Actively Recruiting
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Research Team
A
Arshad Ali, MBBS, MPH, FCPS, MSc
M
Muhammad Mohsin Khan, MD, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Effect of human albumin administration on clinical outcome and hospital cost in patients with subarachnoid hemorrhage.
Jose I Suarez, Larry Shannon, Osama O Zaidat...
https://pubmed.ncbi.nlm.nih.gov/15070109Effectiveness of human albumin for clinical outcome in aneurysmal subarachnoid hemorrhages: a protocol for randomized controlled (HASH) trial.
Arshad Ali, Mohsin Khan, Nissar Shaikh...
https://pubmed.ncbi.nlm.nih.gov/39953562