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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Minimally Invasive Hematoma Evacuation

    Procedure/Surgery

    Procedure of minimally invasive hematoma evacuation PLUS best medical therapy

  • Best Medical Therapy

    Other intervention

    Best medical therapy

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Minimally Invasive Hematoma EvacuationExperimental treatment 2 interventions
Group B: Best Medical TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of score of 0-3 on the modified Rankin scale

Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability.

Time frame
180 days after randomization

Secondary outcomes

1

Score of on the modified Rankin scale

Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability.

Time frame
180 days after randomization

Other outcomes

1

Incidence of symptomatic intracranial hemorrhage

Symptomatic intracranial hemorrhage will be defined according the Heidelberg bleeding classification criteria

Time frame
30 days after randomization

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhongming Qiu

Lead sponsor

Xinqiao Hospital of Chongqing

Sponsor institution

Xingguo County People's Hospital

Collaborator

Source ClinicalTrials.gov
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