Stereotactic Aspiration and Thrombolysis of Intracerebral Hemorrhage: a Prospective Controlled Study (SATIH)
Stereotactic Aspiration and Thrombolysis of Intracerebral Hemorrhage: a Prospective Controlled Study（SATIH）
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Hubei
-
Wuhan, Hubei, Kina, 430030
- Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Intracranial or serious systemic infection
- Marked cognitive impairment or mental abnormality
- Other such as pregnancy, cancer
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 1
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.
|
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.
Andre navne:
|
|
Aktiv komparator: 2
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.
|
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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Hyppigheden af genblødning og dødelighed, Glasgow Outcome Scale for prognose
Tidsramme: varighed på 14 dage efter operation (genblødning), varighed af hospitalsophold (dødelighed), 180 dage efter debut (dødelighed og GOS)
|
varighed på 14 dage efter operation (genblødning), varighed af hospitalsophold (dødelighed), 180 dage efter debut (dødelighed og GOS)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Nation of Health Stroke Scale Score, modificeret Rankin Scale, Barthel Index komplikationer
Tidsramme: tidspunktet for indlæggelse og efter operation (NIHSS), 14 dage efter indlæggelse (NIHSS, MRS), varighed af hospitalsophold (komplikationer), 180 dage efter debut (BI, MRS)
|
tidspunktet for indlæggelse og efter operation (NIHSS), 14 dage efter indlæggelse (NIHSS, MRS), varighed af hospitalsophold (komplikationer), 180 dage efter debut (BI, MRS)
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2006AA301B50-1
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .