Intracerebral hemorrhage (stroke) Circulatory System
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients presenting with clinical syndrome of acute stroke 2. First-ever stroke 3. ICH confirmed on CT of the brain 4. Symptom onset within 6 hours (prior to randomization)
Exclusion criteria
Exclusion criteria: 1. Parenchymal hematoma volume >60 ml on baseline CT head 2. Patients with a deranged bleeding profile or platelet count less than 200,000/mm3 3. Injury or easy bruising of the upper arm skin due to underlying skin condition 4. Pain or tenderness in the upper arm muscles 5. Fever on admission 6. Secondary ICH (cerebral venous thrombosis, aneurysmal hemorrhage, traumatic and hemorrhagic transformation of ischemic stroke) 7. Patient on sulfonylurea medication for diabetes control 8. Patients with known upper arm peripheral arterial disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Edema extension distance (EED) assessed on computed tomography of the head, on day 7 or day of discharge whichever is earlier. This was assessed with the help of a software ANALYZE PRO ver 1 (Biomedical Imaging Resource). The software allows measuring of the hypodense area surrounding the hematoma in threshold-based (5-23 Hounsfield units) manner with semiautomatic tools. The measured perihematomal edema volume (ml) is then run through an equation proposed by Parry-Jones et al to obtain edema extension distance (cm). EED is a surrogate measure of perihematomal edema and is independent of intraparenchymal hematoma volume. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hematoma growth volume at 24 hours and 7 days. Measured by computed tomography of the head and assessed with help of ANALYZE PRO ver 1 (Biomedical Imaging Resource) with threshold-based semiautomatic tools. The hematoma growth was calculated by subtracting the final hematoma volume from the baseline hematoma volume. According to previous studies, hematoma expansion or hematoma growth volume was defined as an absolute increase in the hematoma volume of more than 3 ml. 2. Absolute perihematoma edema (PHE) volume at 24 hours and 7 days measured by computed tomography of the head. 3. Relative PHE volume at 24 hours and 7 days measured by computed tomography of the head. 4. Degree of disability/dependence following stroke measured by Modified Rankin scale (mRS) at day 90, either through individual assessments on follow up or through telephone interviews. | — |
Countries
India