Using human albumin to improve outcomes in patients with aneurysmal subarachnoid hemorrhage
Effectiveness of Human Albumin for Clinical Outcome in Aneurysmal Subarachnoid Hemorrhages: A Protocol for Randomized Controlled (Hash) Trial.
This study is testing if giving human albumin to patients with a type of brain hemorrhage can help improve their recovery compared to standard fluid treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hamad Medical Corporation Industry-sponsored |
| Locations | 1 site (Doha) |
| Trial ID | NCT06548477 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of human albumin in enhancing fluid management for patients suffering from aneurysmal subarachnoid hemorrhage (aSAH). It is a single-center, open-label, prospective, parallel group randomized control trial comparing human albumin therapy to standard crystalloid fluid therapy. The study aims to address the high morbidity and mortality associated with aSAH, particularly focusing on the prevention of cerebral vasospasm, which is a significant contributor to poor clinical outcomes. Participants will be recruited based on specific clinical criteria and will receive treatment within 72 hours of symptom onset.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 who present with symptoms of aSAH within 72 hours and have a confirmed diagnosis of a ruptured aneurysm.
Not a fit: Patients who do not present with symptoms of aSAH or those who have already received definitive treatment beyond the specified time frame may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve clinical outcomes and reduce complications for patients with aneurysmal subarachnoid hemorrhage.
How similar studies have performed: While human albumin has shown promise in other neurological conditions, this specific application in aSAH is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Doha
- Hamad General Hospital — Doha, Qatar (Recruiting)
Study contacts
- Principal investigator: Arshad Ali, MBBS, MPH, FCPS, MSc — Hamad Medical Corporation
- Study coordinator: Arshad Ali, MBBS, MPH, FCPS, MSc
- Email: aali84@hamad.qa
- Phone: (+974) 4439 2799
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.