Effectiveness of Human Albumin for Clinical Outcome in Aneurysmal Subarachnoid Hemorrhages: A Protocol for Randomized Controlled (Hash) Trial.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Qatar
Hamad General Hospital
RECRUITING
Doha
Contact Information
Primary
Arshad Ali, MBBS, MPH, FCPS, MSc
aali84@hamad.qa
(+974) 4439 2799
Backup
Muhammad Mohsin Khan, MD, MSc
mmkyousafzai@gmail.com
(+974) 4439 2440
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 84
Treatments
Experimental: Intervention group (Albumin group)
Intervention group will receive of intermittent boluses of human albumin plus standard fluid therapy (with crystalloids only) to maintain a euvolemic fluid balance.
No_intervention: Control (crystalloid group)
Control group will receive only standard fluid therapy with crystalloid solutions with intermittent boluses crystalloid solution to maintain euvolemic balance
Related Therapeutic Areas
Sponsors
Leads: Hamad Medical Corporation

This content was sourced from clinicaltrials.gov

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