WP 07: Study Conduct

Objectives

The major goal of the work package study conduct is to perform the randomized, controlled, clinical trial in 1500 patients.

Work package Description

This WP is led by Dr. Rainer Kollmar (University of Erlangen-Nürnberg) and Dr. H.B. van der Worp (UMC Utrecht). After registration of the study, we will implement a structured patient inclusion programme  in close cooperation with the national coordinators and the center for clinical studies Erlangen. The most experienced centers will participate in a 24 hours/ 7days helpline in order to facilitate patient inclusion and solve potential treatment problems/questions.

The aim of the study

To determine whether systemic cooling to a target temperature of 34 to 35°C, started within 6 hours of symptom onset and maintained for 24 hours, improves functional outcome at 3 months in patients with acute ischaemic stroke.

Methods

This is an open, randomised, phase III, multicentre, international clinical trial with masked outcome assessment testing the benefits and harms of therapeutic cooling in 1500 awake adult patients with acute ischaemic stroke.

Inclusion criteria

1. A clinical diagnosis of acute ischaemic stroke;

2. A possibility to initiate cooling within 6 hours of symptom onset AND within 90 minutes of start of thrombolysis, OR within 90 minutes of hospital admission in patients who are not treated with thrombolysis;

3. A score on the national Institutes of Health Stroke Scale (NIHSS) of 6 up to and including 18 at the time of study inclusion;

4. Age ≥ 18 years;

5. Written informed consent.

WP Leader

Dr. Rainer Kollmar (UKER)

Dr. H.B. van der Worp (UMC)