- Reference
- Technique
- Selection criteria
Study inclusion criteria | - Age 18–80 years - Pre-randomization head CT demonstrating an acute, spontaneous, primary ICH - ICH volume between 30 and 80 ml as calculated by the ABC/2 method - Study intervention can reasonably be initiated within 24 h after the onset of stroke symptoms. If the actual time of onset is unclear, then the onset will be considered the time that the subject was last known to be well - Glasgow Coma Score GCS 5–14 - Historical Modified Rankin Score 0 or 1 |
Study exclusion criteria | - Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (<1 year) ICH, as diagnosed with radiographic imaging - NIHSS <5 - Bilateral fixed dilated pupils - Extensor motor posturing - Intraventricular extension of the hemorrhage is visually estimated to involve >50% of either of the lateral ventricles - Primary thalamic ICH - Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar - Use of anticoagulants that cannot be rapidly reversed - Evidence of active bleeding involving a retroperitoneal, gastrointestinal, genitourinary, or respiratory tract site - Uncorrected coagulopathy or known clotting disorder - Platelet count <75,000, INR >1.4 after correction - Patients requiring long-term anti-coagulation that needs to be initiated <5 days from index ICH - End stage renal disease - Patients with a mechanical heart valve - End-stage liver disease - History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements - Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or is post-menopausal - Known life-expectancy of <6 months - No reasonable expectation of recovery, DNR, or comfort measures only prior to randomization - Participation in a concurrent interventional medical investigation or clinical trial - Inability or unwillingness of subject or legal guardian/representative to give written informed consent - Homelessness or inability to meet follow up requirements |
- The mean score on the utility-weighted modified Rankin scale at 180 days was 0.458 in the surgery group and 0.374 in the control group (difference, 0.084; 95% Bayesian credible interval, 0.005 to 0.163;
- The percentage of patients who had died by 30 days was 9.3% in the surgery group and 18.0% in the control group.
- 3.3% in the surgery group had postoperative rebleeding and neurologic deterioration.
- Outcome
- Safety end points*
- *Plus–minus values are means ±SD. Percentages were compared across treatment groups with the use of a Bayesian beta-binomial model with noninformative prior distributions.
- ᵃRebleeding was defined as growth in hematoma volume between the initial CT and follow-up neuroimaging. Neurologic deterioration was defined as an increase of 4 or more points on the NIH stroke scale or a decrease of up to 2 points on the GCS that was not explained by planned medical interventions (e.g., sedatives, analgesics, and procedures).
- ᵇThe absolute change in hematoma volume was calculated as the follow-up neuroimaging volume minus the baseline volume. This was a safety measure (i.e., increase in volume can be an early sign of inadequate surgical procedures). One value was missing in the control group.
End point | Surgery group (N=150) | Control group (N=150) | Estimated difference (95% credible interval) | Posterior probability of superiority |
Death by 30 days — no. (%) | 14 (9.3) | 27 (18.0) | -8.7 (-16.4 to -1.0) | 0.987 |
Postoperative rebleeding associated with neurologic deterioration — no. (%)ᵃ | 5 (3.3) | NA | NA | NA |
Change in hematoma volume — mlᵇ | -43.9 ± 30.09 | 4.0 ± 17.82 | -47.91 (-53.59 to -42.36) | >0.999 |
One or more serious adverse events — no. (%) | 95 (63.3) | 118 (78.7) | -15.3 (-25.4 to -5.2) | 0.998 |
Death in the hospital after randomization — no. (%) | 7 (4.7) | 19 (12.7) | -8.0 (-14.5 to -1.8) | 0.994 |
- Critique
- Very strict inclusion and exclusion criteria
- They excluded any patient who are on long term anti coag
- Excluded deep (thalamic and basal ganglia)
- Only 2.6% of PT that were screen were included in the study
Made with Bullet