Remote Ischemic Conditioning for Intracerebral Hemorrhage
Sleutelwoorden
Abstract
Datums
| Laatst geverifieerd: | 01/31/2020 |
| Eerste ingediend: | 04/19/2019 |
| Geschatte inschrijving ingediend: | 04/24/2019 |
| Eerst geplaatst: | 04/28/2019 |
| Laatste update ingediend: | 02/09/2020 |
| Laatste update geplaatst: | 02/10/2020 |
| Werkelijke startdatum van het onderzoek: | 07/08/2019 |
| Geschatte primaire voltooiingsdatum: | 11/16/2019 |
| Geschatte voltooiingsdatum van het onderzoek: | 02/09/2020 |
Conditie of ziekte
Interventie / behandeling
Device: RIC group
Other: Regular treatment
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| Experimental: RIC group RIC treatment and regular treatment. | Device: RIC group RIC is a non-invasive therapy that performed by an electric autocontrol device with cuffs placed on arm and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 4 to 5 times. |
| Other: Control group Regular treatment alone. |
Geschiktheidscriteria
| Leeftijden die in aanmerking komen voor studie | 18 Years Naar 18 Years |
| Geslachten die in aanmerking komen voor studie | All |
| Accepteert gezonde vrijwilligers | Ja |
| Criteria | Inclusion Criteria: 1. Age≥18 and ≤80. 2. The diagnosis of ICH is confirmed by brain CT scan. 3. Hematoma volume of 10 to 30 ml. 4. Glasgow Coma Score (GCS)>8. 5. Starting RIC treatment between 24 and 48 hours of ictus. 6. Signed and dated informed consented is obtained. Exclusion Criteria: 1. Patients with suspected secondary ICH related to tumor, coagulopathy, ruptured aneurysm or arteriovenous malformation, or venous sinus thrombosis. 2. ICH concomitant with subarachnoid hemorrhage or intraventricular hemorrhage. Planned surgical evacuation of hematoma prior to RIC. 3. Evidence of significant shift of midline brain structure (> 10 mm) or herniation on brain imaging. 4. Known pregnancy (or positive pregnancy test), or breast-feeding. 5. Concurrent participation in another research protocol for investigation of another experimental therapy. 6. Patients with a pre-existing neurological deficits (modified Ranks scale score >1) or psychiatric disease that would confound the neurological or functional evaluations. 7. Life expectancy of less than 90 days due to co-morbid conditions. 8. Severe hepatic and renal dysfunction. 9. Severe, sustained hypertension (SBP > 180 mmHg or DBP > 110 mmHg). 10. Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs. 11. Any condition which, in the judgment of the investigator, might increase the risk to the patient. |
Resultaat
Primaire uitkomstmaten
1. Incidence of Treatment-Emergent Adverse Events [Safety] [7 days.]
