Human Albumin for Clinical Outcome in Aneurysmal Subarachnoid Hemorrhages

Launched by HAMAD MEDICAL CORPORATION · Aug 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of human albumin, a protein found in blood, to see if it can improve treatment outcomes for patients with aneurysmal subarachnoid hemorrhage (aSAH), a serious condition caused by bleeding in the space surrounding the brain. The trial will compare traditional fluid therapy with human albumin-enhanced fluid management to see which approach leads to better recovery. Researchers at Hamad General Hospital in Doha, Qatar, will enroll 84 participants, aged 18 to 80, who have shown symptoms of aSAH within the last 72 hours and have been diagnosed with a ruptured aneurysm.

Eligible participants will receive care as usual but may be chosen to receive either the standard treatment or the new human albumin approach. Throughout the study, researchers will monitor their health and recovery progress, focusing on how well they do on a specific scale that measures their ability to function. Participants will be carefully assessed to ensure they meet the study's criteria, and those with certain health conditions or recent treatments may not be able to participate. This trial aims to provide important information that could help improve the care and outcomes for patients facing this critical medical situation.

Gender

ALL

Eligibility 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.