NCT06628817: ICB-MRAIS

The Intensive Care Bundle with Mortality Reduction in Acute Ischemic Stroke Trial

Not yet recruiting NA Last updated 8 October 2024

What this trial tests

NA trial testing The Intensive Care Bundle with Mortality Reduction in Acute Ischemic Stroke in 55,000 participants. Not yet recruiting.

Timeline

1 November 2024

Primary endpoint
30 October 2025

1 November 2026

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	55,000
Start date	1 November 2024
Primary completion	30 October 2025
Estimated completion	1 November 2026

Drugs / interventions tested

• The Intensive Care Bundle with Mortality Reduction

Conditions studied

• Acute Ischemic Stroke — all drugs for Acute Ischemic Stroke →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

18 and older, any sex, with Acute Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Ischemic stroke, also known as cerebral infarction, accounts for as high as 60% to 80% of all stroke cases, and it is characterized by high morbidity, high disability rate, and high mortality rate. In recent years, acute ischemic stroke (AIS) has risen to the top of the list of causes of death in Chinese people, bringing a heavy burden on families, society and the country. In the process of continuous accumulation of evidence-based evidence, the management of stroke has gradually become systematic, and the demand for multi-disciplinary collaboration has become increasingly prominent, thus the concept of organized medical care has emerged.

Improving the prognosis of stroke faces multiple challenges, including timely identification of stroke patients, intravenous thrombolysis after clinical doctors evaluate indications and contraindications, reducing in-hospital stroke complications, accurately diagnosing the cause of stroke and implementing precise prevention. In the past, there were relatively few clinical trials on reducing mortality. The 2023 Dutch PRECIOUS study used metoclopramide, ceftriaxone and acetaminophen to prevent aspiration, infection and fever in elderly patients with acute stroke. The results showed that there was no significant difference in acute 90-day good functional outcomes and reduced mortality. The INTERACT3 trial results showed that for patients with acute cerebral hemorrhage, compared with conventional medical care, the use of a new combination management plan, namely early intensive blood pressure management, strict control of blood sugar elevation, body temperature control and anticoagulation therapy, can significantly reduce the risk of 6-month adverse functional prognosis in patients, improve the survival rate and quality of life of patients, and the possibility of patients being discharged within 7 days. Therefore, the use of a new combination management plan, including improving the efficiency of reperfusion therapy, reducing the occurrence of stroke complications, and carrying out precise etiological treatment, may reduce the mortality rate of patients.

The Zhejiang Stroke Online Platform can monitor the comprehensive information of treatment and management in the process of clinical doctors receiving AIS patients in real time. According to the self-feedback of each unit of the online platform, the provincial center conducts multi-level new combined management intervention on it. The purpose of this study is to explore whether the new combined management intervention measures can reduce the mortality rate of AIS patients on the basis of the implementation of stroke online platform monitoring.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.