Human Albumin for Clinical Outcome in Aneurysmal Subarachnoid Hemorrhages

Recruiting now · Not applicable

Conditions studied: Aneurysmal Subarachnoid Hemorrhage

In brief

Aneurysmal subarachnoid hemorrhage (aSAH) is a dreadful acute neurological condition with overwhelmingly high rate of associated morbidities and mortality. Despite leaping advancement in neurosurgical techniques and imaging modalities, there is no substantiative improvement in overall prognosis for aSAH. Cerebral vasospasm remains the predominant cause of associated morbidities. Human albumin has been used in different neurological conditions including head trauma, intracerebral hemorrhages, and ischemic strokes with favorable outcome. However, its beneficial use in aSAH has not been sufficiently explored until recently a published systematic review by our team. In view of scarcity of published data and lack of robust evidence, our group has designed for the first ever RCT to compare the use human albumin-enhanced fluid management versus standard fluid therapy with crystalloids in patients with aSAH. This single center open label, prospective, parallel group randomized control trial will be conducted at Hamad General Hospital, Doha-Qatar from August 2024 to July 2027. A sample size of 84 (42 in each arm) has been calculated to detect as sufficient to detect a clinically significant difference in modified Rankin Scale good score between two groups (human-albumin induced volume expansion therapy versus crystalloid only) for fluid management in aneurysmal subarachnoid hemorrhages patients. Primary outcome will be based on dichotomized modified Rankin scale \[(Good grades (0-2) and poor grades (3-6)\], while secondary outcome will include symptomatic vasospasm, transcranial doppler velocities, and Pulse Index Contour Cardiac Output (PiCCO) parameters. The trial aims to provide firsthand evidence on the beneficial use of human albumin to achieve optimal fluid management regime to explore its potential role to improve clinical outcome in patients with aSAH.

Key facts

Study ID

NCT06548477

Run by

Hamad Medical Corporation

People needed

84

Starts

2024-08-01

Expected to finish

2027-07-31

Last updated by the study team

2024-08-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Hamad General Hospital — Doha, Qatar (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.