Trial Review

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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
Scientific title
A randomized controlled trial to evaluate the effects of hematoma evacuation plus decompressive craniectomy in patients with basal ganglia or putaminal hemorrhage
Secondary ID [1] 282322 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypertensive intracranial hemorrhage 288865 0
Condition category
Condition code
Neurological 289207 289207 0 0
Other neurological disorders
Stroke 289237 289237 0 0
Haemorrhagic
Cardiovascular 289238 289238 0 0
Hypertension

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 286938 0
Treatment: Surgery
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.
Control group
Active

Outcomes
Primary outcome [1] 289320 0
Functional outcome measured by the Glasgow Outcome Scale and modified Rankin Scale at 1-year follow-up.
Timepoint [1] 289320 0
Till death or one year after stroke
Primary outcome [2] 289357 0
30-day mortality rate after stroke
Timepoint [2] 289357 0
Till death or 30 days after stroke
Secondary outcome [1] 302234 0
Postoperative intracranial pressure levels measured by itraoperativvely-implanted probes
Timepoint [1] 302234 0
Till death or seven days after the surgery
Secondary outcome [2] 302300 0
Manitol dosages after surgery
Timepoint [2] 302300 0
Till death or the first discharge
Secondary outcome [3] 302301 0
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.
Timepoint [3] 302301 0
Till death or the discharge after cranioplasty
Secondary outcome [4] 302302 0
Duration of hospital stay
Timepoint [4] 302302 0
Till death or the dischrage after cranioplasty

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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
Identical preoperative preparations, computer-generated randomization. Envelops containing computer-generated randomized numbers are not opened until operations begin.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomized numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 5014 0
China
State/province [1] 5014 0
Shanghai
Country [2] 5015 0
China
State/province [2] 5015 0
Zhejiang
Country [3] 5016 0
China
State/province [3] 5016 0
Jiangsu

Funding & Sponsors
Funding source category [1] 287086 0
Hospital
Name [1] 287086 0
Shanghai Tenth People's Hospital
Country [1] 287086 0
China
Primary sponsor type
Individual
Name
Ke Wang
Address
301 Middle Yanchang Road, Shanghai,200072
Country
China
Secondary sponsor category [1] 285861 0
Individual
Name [1] 285861 0
Li Chen
Address [1] 285861 0
318 Chaowang Road, Hangzhou, Zhejiang Province, 310005
Country [1] 285861 0
China

Ethics approval
Ethics application status
Approved

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39226 0
Dr Ke Wang
Address 39226 0
Ke Wang
Shanghai Tenth People's Hospital, Tongji University
301 Middle Yanchang Road, Shanghai, China, 200072
Country 39226 0
China
Phone 39226 0
86-02166307370
Fax 39226 0
Email 39226 0
[email protected]
Contact person for public queries
Name 39227 0
Ke Wang
Address 39227 0
Ke Wang
Shanghai Tenth People's Hospital, Tongji University
301 Middle Yanchang Road, Shanghai, China, 200072
Country 39227 0
China
Phone 39227 0
86-02166307370
Fax 39227 0
Email 39227 0
[email protected]
Contact person for scientific queries
Name 39228 0
Ke Wang
Address 39228 0
Ke Wang
Shanghai Tenth People's Hospital, Tongji University
301 Middle Yanchang Road, Shanghai, China, 200072
Country 39228 0
China
Phone 39228 0
86-02166307370
Fax 39228 0
Email 39228 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
No additional documents have been identified.