Stereotactic Aspiration and Thrombolysis of Intracerebral Hemorrhage: a Prospective Controlled Study (SATIH)
Stereotactic Aspiration and Thrombolysis of Intracerebral Hemorrhage: a Prospective Controlled Study（SATIH）
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Hubei
-
Wuhan, Hubei, Cina, 430030
- Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
Altri nomi:
|
|
Comparatore attivo: 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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Il tasso di risanguinamento e mortalità, Glasgow Outcome Scale per la prognosi
Lasso di tempo: durata di 14 giorni dopo l'operazione (risanguinamento), durata della degenza ospedaliera (mortalità), 180 giorni dopo l'esordio (mortalità e GOS)
|
durata di 14 giorni dopo l'operazione (risanguinamento), durata della degenza ospedaliera (mortalità), 180 giorni dopo l'esordio (mortalità e GOS)
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Punteggio della Nation of Health Stroke Scale, scala Rankin modificata, complicanze dell'indice Barthel
Lasso di tempo: il momento del ricovero e post operazione (NIHSS), 14 giorni dopo il ricovero (NIHSS, MRS), la durata della degenza ospedaliera (complicanze), 180 giorni dopo l'esordio (BI, MRS)
|
il momento del ricovero e post operazione (NIHSS), 14 giorni dopo il ricovero (NIHSS, MRS), la durata della degenza ospedaliera (complicanze), 180 giorni dopo l'esordio (BI, MRS)
|
Collaboratori e investigatori
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2006AA301B50-1
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .