Using human albumin to improve outcomes in patients with aneurysmal subarachnoid hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nitric Oxide Use to Predict Vasospasm in Aneurysmal Subarachnoid Hemorrhage

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• Dome-only coiling for severe aneurysmal subarachnoid hemorrhage

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• Transcutaneous Vagal Nerve Stimulation to help with brain vessel narrowing after aneurysm rupture

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• Tocilizumab-aazg to reduce stroke risk after a ruptured brain aneurysm

  This trial will try to see if a single IV dose of tocilizumab-aazg is safe and can help prevent delayed strokes in adults who have had a ruptured brain aneurysm (aneurysmal subarachnoid hemorrhage).

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.