Human Albumin for Clinical Outcome in Aneurysmal Subarachnoid Hemorrhages
NCT Number: NCT06548477
Acronym: HASH
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aneurysmal Subarachnoid Hemorrhage
Interventions: DRUG: Human albumin
Sponsor: Hamad Medical Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2027-07-31
Locations: Hamad General Hospital, Doha, Qatar

Summary:
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.

Primary Outcome Measures: Dichomatized modified Rankin Scale (mRS), Primary clinical outcome will be based on dichotomized modified Rankin Scale \[(Good grades (0 -2) and poor grades (3-6)\]. Primary outcome measures (values of mRS) will be compared between study arms to assess difference in the effect size of the intervention., Endpoints for primary outcome measures (values of mRS) will be assessed on Day-14 and at 3 month follow up.
Secondary Outcome Measures: Development of Symptomatic vasospasm (with/without new onset infarctions on unenhanced Computed Tomography scan, transcranial doppler velocities (daily average) and PiCCO parameters (daily average values), Secondary outcomes will include symptomatic vasospasm (with/without new onset infarctions on unenhanced Computed Tomography scan), transcranial doppler velocities (daily values), and all Pulse index Contour Cardiac Output (PiCCO) parameters (daily average values). On 14th day endpoint, a mean of all cumulative daily averaged values will be recorded for secondary outcome measures for; 1) the study period (4th-10th day) and 2) subsequently without albumin therapy (from day 11th -14th day) on Day-14 end-point. These secondary outcome measures will be compared between study arms to assess difference in the effect size of the intervention., Endpoint for secondary outcome is at day-14.