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Updated: Jan 30, 2026

Double Direct Injection of Blood into the Cisterna Magna as a Model of Subarachnoid Hemorrhage
Published on: August 30, 2020
[Effect of Chinese Drugs for Breaking Blood Expelling Stasis on Acute Cerebral Hemorrhage: a Prospective Randomized
Insights
Chinese drugs for breaking blood expelling stasis (CDBBES) did not increase hematoma enlargement in patients with intracerebral hemorrhage. This study found no significant difference in hematoma enlargement rates among treatment and placebo groups.
Area of Science:
- Neurology
- Pharmacology
- Traditional Chinese Medicine
Background:
- Intracerebral hemorrhage (ICH) is a critical condition often managed with interventions to control bleeding.
- Chinese drugs for breaking blood expelling stasis (CDBBES) are used in traditional medicine, but their safety in acute ICH requires rigorous evaluation.
Purpose of the Study:
- To assess the safety of CDBBES in patients with ICH within 6 hours of onset.
- To determine if CDBBES contributes to hematoma enlargement in this patient population.
Main Methods:
- A prospective, randomized, double-blind, placebo-controlled study involving 76 ICH patients within 6 hours of symptom onset.
- Patients were assigned to receive either whole CDBBES, CDBBES without specific components, or placebo for 10 days.
- Outcomes measured included hematoma enlargement rate within 24 hours and adverse events.
Main Results:
- The hematoma enlargement rates were 11.5% (Group A), 16.0% (Group B), and 20.0% (Group C), with no statistically significant differences between groups (P = 0.682).
- Adverse events were reported in 7 patients, including acute myocardial infarction and diarrhea, primarily in the group receiving whole CDBBES.
Conclusions:
- Interim analysis indicates that CDBBES does not cause hematoma enlargement in patients with intracerebral hemorrhage treated within 6 hours of onset.
- Further research may be warranted to fully elucidate the safety profile and efficacy of CDBBES in ICH management.
Objective:
To study the safety of using Chinese drugs for breaking blood expelling stasis (CDBBES) in hypertension patients with intracerebral hemorrhage within 6 h, and to observe whether they would result in hematoma enlargement.
Methods:
A prospective randomized double-blind controlled clinical study was employed. Totally 128 cerebral hemorrhage patients within 6 h were recruited from 8 research centers from October 2013 to March 2015, and finally 76 of them were included. These patients were assigned to 3 groups by simple random sampling, group A, B, and C. Patients in group A (26 cases) took whole CDBBES recipe (containing leeches and equivalent insects). Those in group B (25 cases) took CDBBES recipe (removing leech and gradfly). Those in group C (25 cases) took placebos. Medication lasted for 10 successive days. The hematoma enlargement rate within 24 h, the occurrence of adverse reactions and adverse events were observed. To guarantee the safety of this trial, an interim analysis of first level unblinding was used.
Results:
The hematoma enlargement rate was 11. 5% (3/26) in group A, 16. 0% (4/25) in group B, and 20. 0% (5/25) in group C. There was no statistical difference in the hematoma enlargement rate among the 3 groups (X² =0. 823, P =0. 682). Adverse reactions and adverse events occurred in 7 cases, 1 patient with acute myocardial infarction, 1 with chest op- pression and palpitation, 2 with diarrhea in group A. No patient had adverse reaction or adverse event in group B. And diarrhea occurred in 3 patients of group C.
Conclusion:
The interim analysis of first level unblinding showed that hematoma enlargement within 6 h was not resulted from using CDBBES.
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