Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000945022
Ethics application status
Approved
Date submitted
2/11/2010
Date registered
5/11/2010
Date last updated
5/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A clinical contrast study on minimally invasive stereotactic puncture and thrombolysis therapy on hemorrhagic
stroke
Scientific title
Minimally invasive stereotactic puncture and thrombolysis therapy versus conventional craniotomy in the treatment of acute intracerebral hemorrhage:a randomized controlled trial
Secondary ID [1] 252997 0
no
Secondary ID [2] 253030 0
no
Universal Trial Number (UTN)
U1111-1117-6523
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute intracerebral hemorrhage 258545 0
Condition category
Condition code
Stroke 258692 258692 0 0
Haemorrhagic
Surgery 258717 258717 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
minimally invasive stereotactic puncture and thrombolysis therapy (one intervention group): firstly, the target points was defined according to the computer tomography and mostly target points were chosen in the scan with the largest expansion of the haematoma. Puncture situs was measured and marked on head noticing to get out of the way of main blood vessel, then puncture needle of suitable length(Type YL-1) was fixed on the operative electric drill. The puncture needle was perforated into predetermined depth, then the probe core removed, hematoma drawn out gently by syringe (diluted by saline solution if blood thicken) until 1/3 of hematoma were removed, then hematoma was continuiosly liquefied by liquefacient(containing 20000U-40000U urokinase/2-3mL saline solution)for 2-4 days(3-5 times per day) until 90% hematoma drained.
Intervention code [1] 257521 0
Treatment: Surgery
Comparator / control treatment
conventional craniotomy:after 6-24h of onset, clearance of hematoma by traditional craniotomy with large bone flap removed was operated in Department of Neurosurgery.
Control group
Active

Outcomes
Primary outcome [1] 259550 0
Glasgow Coma Scale(GCS) score
Timepoint [1] 259550 0
1 year postoperation
Primary outcome [2] 259551 0
activities of daily living (ADL):To study the full impact of haemorrhagic stroke on long-term follow-up,activities of daily living (ADL) were measured with the Barthel Index (BI) 1 year after stroke.
Timepoint [2] 259551 0
1 year postoperation
Secondary outcome [1] 266170 0
modified Rankin Scale (mRS)
Timepoint [1] 266170 0
1 year postoperation

Eligibility
Key inclusion criteria
(1) diagnosed as having spontaneous hemorrhage in the basal ganglion or brain lobe of the brain by CT scan; (2) hemorrhage volume: 30–100 ml; (3) age range: 40–75 years; (4) muscle strength of the paralyzed limbs: grades 0–3 on the muscle strength scale; (5) hemorrhagic duration (from stroke onset to hospital) within 24 h; (6) informed consent from patients and/or their law representative.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) disturbances of blood coagulation, such as thrombocytopenia, hepatitis, etc; (2) traumatic intracranial hemorrhage; (3)intracranial or general infection; (4) complicated with serious heart, liver, renal or lung disease or functional failure; (5) a previous stroke history with neurological deficits; (6) intracranial aneurysm or arteriovenous malformation complicated with hemorrhage; (7) consent form cannot be obtained from the patient herself or her law representative.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A randomized control clinical trial was undertaken. All ICH patients came from in-hospital, diagnosed as ICH according to the ICH criteria of which is drafted by ASA. The clinical trial was in compliance with the WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, and was performed with the approval of our hospital ethics committee(ID JSCS2005058). Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
we generate the sequence by a randomized number generated by computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
no
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 3011 0
China
State/province [1] 3011 0

Funding & Sponsors
Funding source category [1] 257977 0
Self funded/Unfunded
Name [1] 257977 0
Country [1] 257977 0
Primary sponsor type
Individual
Name
zhou houguang
Address
12# Middle WuLuMuQi Rd, Shanghai, 200040,China.
Country
China
Secondary sponsor category [1] 257172 0
Individual
Name [1] 257172 0
xue jianzhong
Address [1] 257172 0
Affiliated ChangShu Hospital, Yangzhou University, Changshu 215500,China
Country [1] 257172 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259979 0
Huanshan Hospital ethics committee
Ethics committee address [1] 259979 0
12# Middle WuLuMuQi Rd, Shanghai, 200040,China
Ethics committee country [1] 259979 0
China
Date submitted for ethics approval [1] 259979 0
07/05/2005
Approval date [1] 259979 0
09/06/2005
Ethics approval number [1] 259979 0
JSCS2005058

Summary
Brief summary
The purpose of this study is to judge the clinical value of minimally invasive stereotactic puncture and thrombolysis therapy (MISPTT) on acute intracerebral hemorrhage(ICH).
A randomized control clinical trial was undertaken by means of compare of Glasgow Coma Scale(GCS) score, postoperative complications(PC) and long-term outcome of 1 year postoperation with conventional craniotomy. We expect to verify whether MISPTT could displayed its superiority in minute trauma, safety, and improving long-term outcome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31857 0
Address 31857 0
Country 31857 0
Phone 31857 0
Fax 31857 0
Email 31857 0
Contact person for public queries
Name 15104 0
zhou houguang
Address 15104 0
12# Middle WuLuMuQi Rd, Shanghai,200040.
Country 15104 0
China
Phone 15104 0
+86 2152887282
Fax 15104 0
+86 2152887285
Email 15104 0
[email protected]
Contact person for scientific queries
Name 6032 0
zhou houguang
Address 6032 0
12# Middle WuLuMuQi Rd, Shanghai,200040.
Country 6032 0
China
Phone 6032 0
+86 2152887282
Fax 6032 0
+86 2152887285
Email 6032 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseA prospective controlled study: Minimally invasive stereotactic puncture therapy versus conventional craniotomy in the treatment of acute intracerebral hemorrhage.2011https://dx.doi.org/10.1186/1471-2377-11-76
N.B. These documents automatically identified may not have been verified by the study sponsor.