Cooling in intracerebral hemorrhage (CINCH) trial: protocol of a randomized German-Austrian clinical trial

作者：Kollmar Rainer^*; Juettler Eric; Huttner Hagen B; Doerfler Arnd; Staykov Dimitre; Kallmuenzer Bernd; Schmutzhard Erich; Schwab Stefan; Broessner Gregor

来源：International Journal of Stroke, 2012, 7(2): 168-172.

DOI：10.1111/j.1747-4949.2011.00707.x

• edema
• hypothermia
• intracerebral hemorrhage
• neuroprotection
• stroke

Background Intracerebral hemorrhage accounts for up to 15% of all strokes and is frequently associated with poor functional outcome and high mortality. So far, there is no clear evidence for a specific therapy, apart from general stroke unit or neurointensive care and management of secondary complications. Promising experimental and pilot clinical data support the use of therapeutic hypothermia after intracerebral hemorrhage. %26lt;br%26gt;Aims The study aims to determine if therapeutic hypothermia improves survival rates and reduces cerebral lesion volume after large intracerebral hemorrhage compared with conventional treatment. %26lt;br%26gt;Material and methods The Cooling in IntraCerebral Hemorrhage trial is a prospective, multicenter, interventional, randomized, parallel, two- arm (1 : 1) phase II trial with blinded end- point adjudication. Enrolment: 50 patients (age: 18 to 65 years) with large (25 to 64 ml on cranial computertomography), primary intracerebral hemorrhage of the basal ganglia or thalamus within 6 to 18 h after symptom onset are randomly allocated to therapeutic hypothermia for eight- days or conventional temperature management. In the therapeutic hypothermia group, a target temperature of 35.0 degrees C is achieved by endovascular catheters and followed by slow controlled rewarming. Data analysis is based on the intentto- treat population. The primary outcome measure of the study is the development in total lesion volume on cranial computertomography (intracerebral hemorrhage plus perihemorrhagic edema on day 8 +/- 0.5 and day 11 +/- 0.5 after intracerebral hemorrhage) and the mortality after 30 days. Secondary end- points are the in-hospital mortality, mortality, and functional outcome (modified Rankin Scale and BarthelIndex) after 90 and 180 days. Safety measures include any adverse events associated with therapeutic hypothermia. %26lt;br%26gt;Discussion In the face of a lack of evidence- based therapies for patients with large intracerebral hemorrhage, new promising approaches are desperately needed, but need evaluation in randomized controlled trials. %26lt;br%26gt;Conclusion The results of Cooling in IntraCerebral Hemorrhage trial are believed to directly influence future therapy of large intracerebral hemorrhage.

• 出版日期2012-2