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Clot removal plus decompressive craniectomy in surgical treatment of patients with hypertensive intracranial hemorrhage

A randomized controlled trial to evaluate the effects of hematoma evacuation plus decompressive craniectomy in patients with basal ganglia or putaminal hemorrhage

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000459729
Enrollment
200
Registered
2013-04-22
Start date
2013-05-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Hematoma evacuation is regarded as a life-saving procedure for a fraction of patients with a large hypertensive intracranial hematoma. Additional early decompressive craniectomy may play a positive role in the surgical management of the disease due to better control of postoperative intracranial pressure. This study compares clinical outcomes between the patients with hematoma evacuation plus decompressive craniectomy and those with hematoma evacuation alone.

Interventions

Enrolled subjects will receive hematoma evacuation using microsurgical techniques plus decompressive craniectomy. A part of ipsilateral temporo-fronal skull with the anterioposterior diameter of 10-15 cm will be removed in the surgery. External ventricular drainage will be applied for the subjects with the hematoma extending into lateral ventricles. An intracrnial pressure monitoring probe will be implanted in the surgery. The surgery will take approximate 120-180 minutes. Cranioplasty will be p

Enrolled subjects will receive hematoma evacuation using microsurgical techniques plus decompressive craniectomy. A part of ipsilateral temporo-fronal skull with the anterioposterior diameter of 10-15 cm will be removed in the surgery. External ventricular drainage will be applied for the subjects with the hematoma extending into lateral ventricles. An intracrnial pressure monitoring probe will be implanted in the surgery. The surgery will take approximate 120-180 minutes. Cranioplasty will be performed at 4-6 moths after the first surgery, which will take about 45-60 minutes.

Sponsors

Ke Wang
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

(1)patients who suffered from hypertensive basal ganglia or putaminal hemorrhage with a least volume of 30 mL; (2) admitted within 24 hours after ictus; (3) the Glasgow Coma Scale score of 4 or higher; (4) informed consent is obtained from family members

Exclusion criteria

(1) Failure to obtain informed consent; (2) Presence of coagulation disorders or thrombocytopenia before surgery; (3) Presence of chronic heart failure, respiratory insufficiency, liver dysfunction or renal impairment before surgery; (4) Patients on oral anticoagulant agents before admission.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026