Modified Stereotactic Aspiration and Thrombolysis of Intracerebral Hemorrhage:a Multi-center Controlled Study

NCT00940745 | Unknown DMC

• 1 other identifier: 2009JX4A03
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertensive Intracerebral Hemorrhage

Keywords

HICH; Suction drainages; TTAC

Outcome Measures

Primary Outcomes (1)

• The rate of rebleeding and mortality, Glasgow Outcome Scale for prognosis

  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

  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)

Study Arms (2)

Stereotactic Aspiration and Thrombolysis

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.

Device: Stereotactic Aspiration and Thrombolysis

conservative treatment

ACTIVE COMPARATOR

dehydrating agent, haemostatic 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.

Drug: conservative treatment

Interventions

Stereotactic Aspiration and Thrombolysis DEVICE

Device: YL-1 type of intracranial hematoma puncture needle 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.

Also known as: aspiration drainage

Stereotactic Aspiration and Thrombolysis

conservative treatment DRUG

dehydrating agent, haemostatic 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.

Also known as: traditional therapy

conservative treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CT diagnosis of spontaneous supratentorial intracerebral hemorrhage, the amount of bleeding is more than 30 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.
• former GCS score \> = 5 points
• Systolic blood pressure \<= 200 mmHg, mean arterial pressure \<= 150 mmHg
• Fasting plasma glucose \<= 11.1 mmol / L
• Patients aged 18 to 80
• 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.

You may not qualify if:

• Patients clotting mechanisms are obstacles or having the experience of he 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
• Intracranial or serious systemic infection
• Marked cognitive impairment or mental abnormality
• patients with possible poor compliance or fail to be followed up
• Other such as pregnancy, cancer

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Intracranial Hemorrhage, Hypertensive

Interventions

Suction; Conservative Treatment

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drainage; Surgical Procedures, Operative; Therapeutics

Study Officials

• Zhouping Tang, doctor

  Tongji Hospital

  STUDY DIRECTOR

Central Study Contacts

Zhouping Tang, doctor

CONTACT

86-013971616328; ddjtzp@163.com

Wei Wang, doctor

CONTACT

86-027-8366-3648; daodetongji@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 15, 2009
• First Posted: July 16, 2009
• Study Start: July 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 16, 2009

Record last verified: 2009-07

Locations

CN (1)