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Trial registered on ANZCTR
Registration number
ACTRN12613000459729
Ethics application status
Approved
Date submitted
13/04/2013
Date registered
22/04/2013
Date last updated
22/04/2013
Type of registration
Prospectively registered
Titles & IDs
Public title
Clot removal plus decompressive craniectomy in surgical treatment of patients with hypertensive intracranial hemorrhage
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Scientific title
A randomized controlled trial to evaluate the effects of hematoma evacuation plus decompressive craniectomy in patients with basal ganglia or putaminal hemorrhage
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Secondary ID [1]
282322
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
hypertensive intracranial hemorrhage
288865
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Condition category
Condition code
Neurological
289207
289207
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0
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Other neurological disorders
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Stroke
289237
289237
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0
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Haemorrhagic
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Cardiovascular
289238
289238
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0
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
286938
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Treatment: Surgery
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Comparator / control treatment
Subjects will receive hematoma evacuation alone using microsurgical techniques. Bone flap will be returned 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 appromiate 120-180 minutes.
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Control group
Active
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Outcomes
Primary outcome [1]
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Functional outcome measured by the Glasgow Outcome Scale and modified Rankin Scale at 1-year follow-up.
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Assessment method [1]
289320
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Timepoint [1]
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Till death or one year after stroke
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Primary outcome [2]
289357
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30-day mortality rate after stroke
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Assessment method [2]
289357
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Timepoint [2]
289357
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Till death or 30 days after stroke
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Secondary outcome [1]
302234
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Postoperative intracranial pressure levels measured by itraoperativvely-implanted probes
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Assessment method [1]
302234
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Timepoint [1]
302234
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Till death or seven days after the surgery
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Secondary outcome [2]
302300
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Manitol dosages after surgery
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Assessment method [2]
302300
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Timepoint [2]
302300
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Till death or the first discharge
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Secondary outcome [3]
302301
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Complications during hospitalization including intracranial rebleeding confirmed by radiographic images, postoperative meningitis by cerebrospinal fluid culture and clinical symptoms, postoperative epilepsy by clinical symptoms, pneumonia by sputum culture and clinical symptoms, acute gastrointestinal bleeding, acute renal failure.
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Assessment method [3]
302301
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Timepoint [3]
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Till death or the discharge after cranioplasty
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Secondary outcome [4]
302302
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Duration of hospital stay
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Assessment method [4]
302302
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Timepoint [4]
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Till death or the dischrage after cranioplasty
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Identical preoperative preparations, computer-generated randomization. Envelops containing computer-generated randomized numbers are not opened until operations begin.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomized numbers.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/05/2013
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
5014
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China
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State/province [1]
5014
0
Shanghai
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Country [2]
5015
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China
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State/province [2]
5015
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Zhejiang
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Country [3]
5016
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China
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State/province [3]
5016
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Jiangsu
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Funding & Sponsors
Funding source category [1]
287086
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Hospital
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Name [1]
287086
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Shanghai Tenth People's Hospital
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Address [1]
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301 Middle Yanchang Road, Shanghai, China, 200072
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Country [1]
287086
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China
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Primary sponsor type
Individual
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Name
Ke Wang
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Address
301 Middle Yanchang Road, Shanghai,200072
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Country
China
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Secondary sponsor category [1]
285861
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Individual
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Name [1]
285861
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Li Chen
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Address [1]
285861
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318 Chaowang Road, Hangzhou, Zhejiang Province, 310005
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Country [1]
285861
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China
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Ethics approval
Ethics application status
Approved
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
39226
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Dr Ke Wang
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Address
39226
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Ke Wang
Shanghai Tenth People's Hospital, Tongji University
301 Middle Yanchang Road, Shanghai, China, 200072
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Country
39226
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China
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Phone
39226
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86-02166307370
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Fax
39226
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Email
39226
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[email protected]
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Contact person for public queries
Name
39227
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Dr Ke Wang
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Address
39227
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Ke Wang
Shanghai Tenth People's Hospital, Tongji University
301 Middle Yanchang Road, Shanghai, China, 200072
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Country
39227
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China
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Phone
39227
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86-02166307370
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Fax
39227
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Email
39227
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[email protected]
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Contact person for scientific queries
Name
39228
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Dr Ke Wang
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Address
39228
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Ke Wang
Shanghai Tenth People's Hospital, Tongji University
301 Middle Yanchang Road, Shanghai, China, 200072
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Country
39228
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China
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Phone
39228
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86-02166307370
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Fax
39228
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Email
39228
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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