A pioneering clinical trial investigating the therapeutic potential of human albumin in aneurysmal subarachnoid hemorrhage (aSAH) is set to commence at Hamad General Hospital, Doha, Qatar. The study, running from August 2024 to July 2027, marks the first randomized controlled trial of its kind in this critical area of neurosurgical care.
The HASH (Human Albumin in Subarachnoid Hemorrhage) trial will evaluate whether human albumin-enhanced fluid management can improve outcomes in aSAH patients compared to standard crystalloid therapy. This investigation comes at a crucial time, as aSAH continues to carry significant mortality rates of up to 60% within the first month if left untreated.
Disease Burden and Current Challenges
Aneurysmal subarachnoid hemorrhage represents approximately 5% of all stroke cases, predominantly affecting working-age individuals. Despite advances in neurosurgical techniques and critical care, cerebral vasospasm remains a major complication, contributing to poor outcomes in nearly 30% of patients.
Dr. Suarez and colleagues' pilot study (ALISAH) previously suggested that albumin might effectively prevent cerebral vasospasm's deleterious effects by enhancing cerebral blood flow. However, until now, no randomized controlled trial has definitively evaluated this potential benefit.
Trial Design and Methodology
The study will enroll 84 patients, randomly assigned to either receive human albumin plus crystalloid or standard crystalloid therapy alone. Key features of the trial include:
- Patient eligibility: Ages 18-80 years, presenting within 72 hours of aSAH onset
- Intervention protocol: Administration of 20% human albumin at 1.25g/kg body weight per 24 hours, divided into three doses
- Primary outcome measure: Modified Rankin Scale scores at day 14 and 3-month follow-up
- Secondary endpoints: Development of delayed cerebral ischemia, transcranial Doppler velocities, and hemodynamic parameters
Scientific Rationale
Human albumin's potential benefits in aSAH stem from multiple neuroprotective mechanisms, including:
- Regulation of intracellular calcium
- Modulation of arachidonic acid concentration
- Enhancement of cellular antioxidation
- Inhibition of adhesion molecular expression
Clinical Implications
"This trial aims to provide firsthand evidence on the beneficial use of human albumin to achieve optimal fluid management and explore its potential role in improving clinical outcomes in aSAH patients," states the research team. The results could significantly impact treatment protocols for this severe neurological condition.
The study addresses a critical need in neurosurgical care, as current treatment modalities, including calcium channel blockers and triple-H therapy, have shown limited success in improving clinical outcomes. A positive result could establish human albumin as a valuable therapeutic option in the management of aSAH.
The trial is registered at ClinicalTrials.gov (NCT06548477) and will be conducted under the oversight of Hamad Medical Corporation's Medical Research Center and Clinical Trial Unit.
