Effectiveness 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/Actively Recruiting
Led by Hamad Medical Corporation · Updated on 2024-08-12
84
Participants Needed
1
Research Sites
N/A
Total Duration
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 gkg 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
Human Albumin for Clinical Outcome in Aneurysmal Subarachnoid Hemorrhages
A
Arshad Ali, MBBS, MPH, FCPS, MSc
M
Muhammad Mohsin Khan, MD, MSc
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Hamad Medical Corporation
Lead Sponsor
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Duration - Up to 72 hours before randomization
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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