Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439615
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-28
Brief Title:
Baricitinib for the Lung Injury Following Spontaneous SAH
Sponsor:
Tang-Du Hospital
Organization:
Tang-Du Hospital
Study Overview
Official Title:
The Treatment Effect of Baricitinib for the Secondary Pulmonary Complications Following Spontaneous Subarachnoid Hemorrhage
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BLISS
Brief Summary:
The present study is a randomized parallel control and double-blind trial designed to assess the efficacy of baricitinib in reducing the occurrence of pulmonary complications in patients with spontaneous subarachnoid hemorrhage SAH The research protocol incorporates an adaptive design allowing for modifications to key elements such as the sample size enrolled during interim analysis
Detailed Description:
Subarachnoid hemorrhage SAH is an acute cerebrovascular disorder resulting from the rupture of intracranial vessels primarily caused by factors such as the rupture of intracranial aneurysms accounting for approximately 75-80 of SAH cases arteriovenous malformations and abnormal vasculature
Pulmonary complications including pneumonia and acute respiratory distress syndrome ARDS frequently manifest in a significant number of subarachnoid hemorrhage SAH patients significantly impacting their prognosis The pathogenesis of these complications can be partially attributed to an exaggerated inflammatory response during the acute phase following SAH The incidence of cerebrovascular spasm and mortality rates significantly increase in SAH patients with pulmonary complications thereby resulting in a poorer long-term prognosis However the current strategy for preventing or managing pulmonary complications after SAH is not sufficiently effective
The JAK-STAT signaling pathway a pivotal stress-induced inflammatory cascade triggered subsequent to SAH is characterized by its rapid response to external stimuli Baricitinib a JAK inhibitor developed by Eli Lilly Company exerts significant anti-inflammatory effects in diverse pathological processes and finds extensive application in patients with rheumatoid arthritis COVID-19 and alopecia areata However it remains uncertain whether early administration of baricitinib can mitigate the incidence of secondary pulmonary complications and enhance the prognosis of SAH by suppressing the exaggerated inflammatory response during the acute phase following SAH
The current multicenter clinical trial is designed as a randomized parallel control and double-blind study to assess the efficacy of baricitinib in reducing pulmonary complications among patients with SAH SAH Patients admitted to participating clinical centers with a Hunt-Hess score of Ⅲ-Ⅳ will undergo continuous screening based on predefined selection criteria The enrolled subjects will be randomly allocated into an experimental group and a control group receiving either Baricitinib 4mgday for 3 days in addition to conventional treatment or placebo in addition to conventional treatment respectively The primary outcome is the incidence of pneumonia within 14 days after SAH While the secondary outcome including the incidence of ARDS and other pulmonary complications within 14 days the incidence of serious adverse events within 14 days the proportion of patients requiring assisted ventilation measures within 14 days the mortality rate within 143090 days as well as the neurological outcome at 3090 days
Pulmonary complications including pneumonia and acute respiratory distress syndrome ARDS frequently manifest in a significant number of subarachnoid hemorrhage SAH patients significantly impacting their prognosis The pathogenesis of these complications can be partially attributed to an exaggerated inflammatory response during the acute phase following SAH The incidence of cerebrovascular spasm and mortality rates significantly increase in SAH patients with pulmonary complications thereby resulting in a poorer long-term prognosis However the current strategy for preventing or managing pulmonary complications after SAH is not sufficiently effective
The JAK-STAT signaling pathway a pivotal stress-induced inflammatory cascade triggered subsequent to SAH is characterized by its rapid response to external stimuli Baricitinib a JAK inhibitor developed by Eli Lilly Company exerts significant anti-inflammatory effects in diverse pathological processes and finds extensive application in patients with rheumatoid arthritis COVID-19 and alopecia areata However it remains uncertain whether early administration of baricitinib can mitigate the incidence of secondary pulmonary complications and enhance the prognosis of SAH by suppressing the exaggerated inflammatory response during the acute phase following SAH
The current multicenter clinical trial is designed as a randomized parallel control and double-blind study to assess the efficacy of baricitinib in reducing pulmonary complications among patients with SAH SAH Patients admitted to participating clinical centers with a Hunt-Hess score of Ⅲ-Ⅳ will undergo continuous screening based on predefined selection criteria The enrolled subjects will be randomly allocated into an experimental group and a control group receiving either Baricitinib 4mgday for 3 days in addition to conventional treatment or placebo in addition to conventional treatment respectively The primary outcome is the incidence of pneumonia within 14 days after SAH While the secondary outcome including the incidence of ARDS and other pulmonary complications within 14 days the incidence of serious adverse events within 14 days the proportion of patients requiring assisted ventilation measures within 14 days the mortality rate within 143090 days as well as the neurological outcome at 3090 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None