DTI-guided Minimally Invasive Hematoma Evacuation for Intracerebral Hemorrhage
ConditionStroke Hemorrhagic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhongming Qiu
About this trial
Intracerebral hemorrhage (ICH) is a devastating disease with high early mortality, unfavorable neurological outcomes, and high cost of care. To date, the role of DTI-guided minimally invasive hematoma evacuation in ICH is still uncertain.
The investigators will conduct a multicenter randomized controlled trial, as well as a concurrent prospective observational study including all ICH patients who decline participation in the trial and will therefore receive minimally invasive hematoma evacuation or best medical therapy and consent to be followed up. All participants will be followed up at the same time using the same outcomes measures. The primary outcome will be collected by a blinded assessor.
Eligibility criteria
Qualifiers
Age 18-80 years old;
Intracerebral hemorrhage in the basal ganglia was diagnosed by CT examination;
The amount of bleeding is 20-40ml, and the midline structure is displaced horizontally by < 3mm in the pineal gland;
The degree of integrity and continuity of the corticospinal tract on the lesion side of magnetic resonance diffusion tensor imaging was graded as grade 2~4;
Disqualifiers
Bleeding in other parts (e.g., bleeding in subtentorial areas such as thalamus, brainstem or cerebellum);
Bleeding caused by other causes (such as aneurysm, arteriovenous malformation, brain trauma, brain tumor, bleeding transformation of large cerebral infarction, bleeding caused by β amyloidosis, bleeding caused by coagulation dysfunction) or combined with aneurysm, arteriovenous malformation, brain trauma, brain tumor, large-scale cerebral infarction, β amyloidosis, severe coagulation dysfunction;
Multiple intracranial hemorrhage;
Patients with ventricular hemorrhage or ICH rupture into the ventricles should consider the need for ventricular drainage;
Trial design
Treatments tested in this trial
- Minimally Invasive Hematoma Evacuation
- Best Medical Therapy
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Zhongming Qiu
Lead sponsor
Xinqiao Hospital of Chongqing
Sponsor institution
Xingguo County People's Hospital
Collaborator
Source ClinicalTrials.gov