Hypertensive Intracerebral HemorrhageSATIHNCT00752024
Stereotactic Aspiration and Thrombolysis of Intracerebral Hemorrhage: a Prospective Controlled Study
A study testing YL-1 type of intracranial hematoma puncture needle and dehydrating agent, haemostatic in people with Hypertensive Intracerebral Hemorrhage, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The purpose of this study is to evaluate the superiority of effect of the modified micro-invasive aspiration and drainage and conservative medical therapy in the treatment of ICH spontaneously hypertensive scientifically. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertensive Intracerebral Hemorrhage
- What is being tested?
- YL-1 type of intracranial hematoma puncture needle and dehydrating agent, haemostatic
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CT diagnosis of spontaneous supratentorial intracerebral hemorrhage, the amount of bleeding more than 50 ml, and had neurological signs
- All income groups the incidence of medical records to be random, the time should be < 69 hours to ensure that within 72 hours of the onset of the operation
- To be random, former GCS score > = 5 points
- Systolic blood pressure <= 200 mmHg, mean arterial pressure <= 150 mmHg (if higher than this value, but as corresponding to this standard can be dealt with the group, and only reached the standard before they can ask for random)
- Fasting plasma glucose <= 11.1 mmol / L (if higher than this value, but as corresponding to this standard can be dealt with the group, and only reached the standard before they can ask for random)
- Patients aged 18 to 80-year-old.
- Based on China's relevant laws, the patient himself or family members (only in patients with the loss of his ability to judge the acts of circumstances) agreed to participate in this study, a good compliance, to fully comply with random, in accordance with the decision by the treatment, patients himself Or family members must sign informed consent moreover.
- Patients themselves or their families (only in patients with the loss of his ability to judge the acts of circumstances) have willingness and ability to follow the research program, data collection and preservation of history and follow-up process of informed consent.
Who cannot join
- Patients clotting mechanisms are obstacles or having the experience of the use of anticoagulant drug (PT> 15s, APTT> 40s, INR> 1.4, platelet count <100 × 10 9 / L).
- Cerebral hernia formed more than two hours
- The merger of other serious system failure (heart, liver and kidney, etc.) or a variety of end-stage disease with cerebral hematoma (such as renal failure late cerebral hemorrhage, blood disease with cerebral hemorrhage)
- Prior to the onset of a variety of reasons for the defect or neurological movement disorder
- A clear cause of cerebral hemorrhage such as intracranial aneurysm, or dynamic
- such as a venous malformation
Show all 9Show fewer
- Intracranial or serious systemic infection
- Marked cognitive impairment or mental abnormality
- Other such as pregnancy, cancer
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
wei wang, doctor, 86-027-8366-3648, daodetongji@163.com
zhouping tang, doctor, 86-013971616328, ddjtzp@163.com
About this study
Official title: Stereotactic Aspiration and Thrombolysis of Intracerebral Hemorrhage: a Prospective Controlled Study（SATIH）
The purpose of this study is to evaluate the superiority of effect of the modified micro-invasive aspiration and drainage and conservative medical therapy in the treatment of ICH spontaneously hypertensive scientifically.
Read the detailed description
The stereotactic computed tomographic-guided aspiration and drainage is one of the best choices in the treatment of a large-scale deep supratentorial intracerebral hematoma. It uses hardware access technology, in a relatively short time to enter the hematoma center, with suction liquefaction technology. It has the advantage of a higher clearance rate of the hematoma, simple convenience, small trauma and low-cost. We carry on the suitable improvement in this technology's foundation in view of its deficiency, the introduction of the concept of the individual, will further reduce the rate of bleeding and mortality, improve survival, such as long-term quality of life.
We will adopt scales such as the rate of rebleeding, mortality, complication,NIHSS, MRS, BI, GOS scale to analysis and evaluating efficacy and safety of this technology and conservative treatment in the treatment of HICH.
- Conditions
- Hypertensive Intracerebral Hemorrhage
- Being tested
- YL-1 type of intracranial hematoma puncture needle, dehydrating agent, haemostatic
- Keywords
- HICH, Suction drainages, TTAC
- Medical subject headings
- Intracranial Hemorrhage, Hypertensive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YL-1 type of intracranial hematoma puncture needleDevice
Also called aspiration drainage
YL-1 type of intracranial hematoma puncture needle(Pat. NO.is ZL：93244252•8) was originated by Beijing WanTeFu Medical Apparatus Co.Ltd in 1997. With integration of needle and bur drill it is designed as hard tunnel.By the technique of skull self-holding, the puncture needle can being fixed in the target of haematoma for several days.This technique is convenient, simple and safe.
To position haematoma's location, drills 3 millimeter holes in the localization point of puncture, then insert the drainage tube to inhale haematoma, gives the filament resolver interrupted for liquefication drainage afterward.
dehydrating agent, haemostaticDrug
Also called conservative treatment
In the treatment, under the convention we use the dehydrator for patients, the ultra early patient may use anti-filament medicinal preparation 6- amino-caproic acid 6-12g/d, intravenous drip, the period of revolution does not surpass for 24 hours, then just right for the illness treatment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | To position haematoma's location, drills several millimeter holes in the localization point of puncture, then insert the drainage tube to inhale haematoma, gives the filament resolver interrupted for liquefication drainage afterward. Receives: Device: YL-1 type of intracranial hematoma puncture needle |
| 2 | Active comparator | In the treatment, under the convention we use the dehydrator for patients, the ultra early patient may use anti-filament medicinal preparation 6- amino-caproic acid 6-12g/d, intravenous drip, the period of revolution does not surpass for 24 hours, then just right for the illness treatment. Receives: Drug: dehydrating agent, haemostatic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of rebleeding and mortality, Glasgow Outcome Scale for prognosis
Measured: duration of 14 days after operation(rebleeding), duration of hospital stay(mortality), 180 days after onset(mortality and GOS)
Secondary outcomes (1)
Nation of Health Stroke Scale Score , modified Rankin Scale, Barthel Index complications
Measured: the moment of admission and post operation(NIHSS), 14 days after admission(NIHSS,MRS), duration of hospital stay(complications), 180 days after onset(BI, MRS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertensive Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Investigators
- wei wang, doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752024
- Sponsor's protocol ID
- 2006AA301B50-1
- Acronym
- SATIH
- Status last verified
- Sep 2008
- First submitted
- 9 Jun 2008
- Last updated
- 15 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tang ZP, Shi YH, Yin XP, Xu JZ, Zhang SM, Wang W. Modifying the details of aspiration operation may contribute to the improvement of prognosis of patients with ICH. Turk Neurosurg. 2012;22(1):13-20. doi: 10.5137/1019-5149.JTN.4219-11.0.
PubMed 22274965
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Aspiration and Thrombolysis of Intracerebral Hemorrhage: a Prospective Controlled Study（SATIH）
- ClinicalTrials.gov ID
- NCT00752024
- Acronym / sponsor ID
- SATIH / 2006AA301B50-1
- Conditions
- Hypertensive Intracerebral Hemorrhage
- Keywords
- HICH, Suction drainages, TTAC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 15 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the superiority of effect of the modified micro-invasive aspiration and drainage and conservative medical therapy in the treatment of ICH spontaneously hypertensive scientifically.
Detailed description
The stereotactic computed tomographic-guided aspiration and drainage is one of the best choices in the treatment of a large-scale deep supratentorial intracerebral hematoma. It uses hardware access technology, in a relatively short time to enter the hematoma center, with suction liquefaction technology. It has the advantage of a higher clearance rate of the hematoma, simple convenience, small trauma and low-cost. We carry on the suitable improvement in this technology's foundation in view of its deficiency, the introduction of the concept of the individual, will further reduce the rate of bleeding and mortality, improve survival, such as long-term quality of life.
We will adopt scales such as the rate of rebleeding, mortality, complication,NIHSS, MRS, BI, GOS scale to analysis and evaluating efficacy and safety of this technology and conservative treatment in the treatment of HICH.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: YL-1 type of intracranial hematoma puncture needleTo position haematoma's location, drills several millimeter holes in the localization point of puncture, then insert the drainage tube to inhale haematoma, gives the filament resolver interrupted for liquefication drainage afterward. |
| 2 | Active comparator | Drug: dehydrating agent, haemostaticIn the treatment, under the convention we use the dehydrator for patients, the ultra early patient may use anti-filament medicinal preparation 6- amino-caproic acid 6-12g/d, intravenous drip, the period of revolution does not surpass for 24 hours, then just right for the illness treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- CT diagnosis of spontaneous supratentorial intracerebral hemorrhage, the amount of bleeding more than 50 ml, and had neurological signs
- All income groups the incidence of medical records to be random, the time should be < 69 hours to ensure that within 72 hours of the onset of the operation
- To be random, former GCS score > = 5 points
- Systolic blood pressure <= 200 mmHg, mean arterial pressure <= 150 mmHg (if higher than this value, but as corresponding to this standard can be dealt with the group, and only reached the standard before they can ask for random)
- Fasting plasma glucose <= 11.1 mmol / L (if higher than this value, but as corresponding to this standard can be dealt with the group, and only reached the standard before they can ask for random)
Key exclusion criteria (9 listed)
- Patients clotting mechanisms are obstacles or having the experience of the use of anticoagulant drug (PT> 15s, APTT> 40s, INR> 1.4, platelet count <100 × 10 9 / L).
- Cerebral hernia formed more than two hours
- The merger of other serious system failure (heart, liver and kidney, etc.) or a variety of end-stage disease with cerebral hematoma (such as renal failure late cerebral hemorrhage, blood disease with cerebral hemorrhage)
- Prior to the onset of a variety of reasons for the defect or neurological movement disorder
- A clear cause of cerebral hemorrhage such as intracranial aneurysm, or dynamic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YL-1 type of intracranial hematoma puncture needleAlso: aspiration drainageYL-1 type of intracranial hematoma puncture needle(Pat. NO.is ZL：93244252•8) was originated by Beijing WanTeFu Medical Apparatus Co.Ltd in 1997. With integration of needle and bur drill it is designed as hard tunnel.By the technique of skull self-holding, the puncture needle can being fixed in the target of haematoma for several days.This technique is convenient, simple and safe. To position haematoma's location, drills 3 millimeter holes in the localization point of puncture, then insert the drainage tube to inhale haematoma, gives the filament resolver interrupted for liquefication drainage afterward. | Device | 1 |
| dehydrating agent, haemostaticAlso: conservative treatmentIn the treatment, under the convention we use the dehydrator for patients, the ultra early patient may use anti-filament medicinal preparation 6- amino-caproic acid 6-12g/d, intravenous drip, the period of revolution does not surpass for 24 hours, then just right for the illness treatment. | Drug | 2 |
Primary outcome
The rate of rebleeding and mortality, Glasgow Outcome Scale for prognosis
Time frame: duration of 14 days after operation(rebleeding), duration of hospital stay(mortality), 180 days after onset(mortality and GOS)
1 secondary outcome
Nation of Health Stroke Scale Score , modified Rankin Scale, Barthel Index complications
Time frame: the moment of admission and post operation(NIHSS), 14 days after admission(NIHSS,MRS), duration of hospital stay(complications), 180 days after onset(BI, MRS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2008.
- Derived from this study: PubMed 22274965Tang ZP, Shi YH, Yin XP, Xu JZ, Zhang SM, Wang W. Modifying the details of aspiration operation may contribute to the improvement of prognosis of patients with ICH. Turk Neurosurg. 2012;22(1):13-20. doi: 10.5137/1019-5149.JTN.4219-11.0.
Related trials for Hypertensive Intracerebral Hemorrhage
Not yet recruitingPhase 3
Huayu Jiedu Formula (FTFY-919) Granules Versus Traditional Decoction for Acute Hypertensive Intracerebral Hemorrhage
Intracerebral Hemorrhage, Hypertension
Not yet recruiting
Efficacy and Safety of Antihypertensive Treatment With Mobile Stroke Units in Ultra-Early Intracerebral Hemorrhage
Nervous System Diseases, Cerebrovascular Disorders
Not yet recruiting
Yiqi Huayu Jiedu Therapy for Non-Surgical Supratentorial Hypertensive Intracerebral Hemorrhage
Intracranial Hemorrhage, Hypertensive
Recruiting
Timing of Venous Thromboembolism Prophylaxis in Patients With Hypertensive Intracerebral Hemorrhage
Venous Thromboembolism, Pulmonary Embolism
Not yet recruitingPhase 2
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial on the Treatment of Hypertensive Intracerebral Hemorrhage With Naoxuekang Dropping Pills
Hypertensive Intracerebral Hemorrhage, Cerebral Small Vessel Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wei wang, doctor principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YL-1 type of intracranial hematoma puncture needle and dehydrating agent, haemostatic in people with Hypertensive Intracerebral Hemorrhage, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wei wang, doctor (86-027-8366-3648, daodetongji@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of rebleeding and mortality, Glasgow Outcome Scale for prognosis (time frame: duration of 14 days after operation(rebleeding), duration of hospital stay(mortality), 180 days after onset(mortality and GOS)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00752024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2008.