OBJECTIVES: To evaluate and compare the curative effect between the minimally invasive craniopuncture combined with urokinase infusion therapy and the clearance of hematoma by craniotomy with small bone flap in treating patients with 30-80 ml hemorrhage in the basal ganglion part of the brain. METHODS: A multicenter, randomized control clinical trial was undertaken; it comprised of 22 hospitals in China. Three hundred and four patients with hemorrhage in the basal ganglion were randomly assigned to receive the craniopuncture combined with urokinase infusion therapy (n=159) or clearance of hematoma by craniotomy with small bone flap treatment (n=145). The main indexes of evaluation were the neurological impairment degree at day 14 after treatment, activities of daily living at day 90 and the case fatality by 90 days. RESULTS: The main results were as follows: (1) there was a significant difference in favorable outcomes (Barthel index >or=95) between the two groups (chi(2)=3.95, p<0.05), which showed a better prognosis in the craniopuncture group, although there was no significant difference in improving the neurological functions and activities of daily living at day 90; (2) there was a remarkable decrease in case fatality by 90 days in the cranipuncture group, with statistically significant difference between the two groups (chi(2)=5.35, p=0.02); (3) the re-bleeding rate in cranipuncture group was 8.8%, significantly (chi(2)=9.51, p=0.002) lower than 21.4% in the craniotomy group. CONCLUSION: The craniopuncture combined with urokinase infusion therapy could reduce the rate of re-bleeding after surgery and the case fatality by 90 days. It also could improve the activities of daily living (Barthel index >or=95) at day 90. Thus, this therapy was a safe and practical technique in treating cerebral hemorrhage (30-80 ml), especially suitable for hospitals in rural areas or developing countries.
RCT Entities:
OBJECTIVES: To evaluate and compare the curative effect between the minimally invasive craniopuncture combined with urokinase infusion therapy and the clearance of hematoma by craniotomy with small bone flap in treating patients with 30-80 ml hemorrhage in the basal ganglion part of the brain. METHODS: A multicenter, randomized control clinical trial was undertaken; it comprised of 22 hospitals in China. Three hundred and four patients with hemorrhage in the basal ganglion were randomly assigned to receive the craniopuncture combined with urokinase infusion therapy (n=159) or clearance of hematoma by craniotomy with small bone flap treatment (n=145). The main indexes of evaluation were the neurological impairment degree at day 14 after treatment, activities of daily living at day 90 and the case fatality by 90 days. RESULTS: The main results were as follows: (1) there was a significant difference in favorable outcomes (Barthel index >or=95) between the two groups (chi(2)=3.95, p<0.05), which showed a better prognosis in the craniopuncture group, although there was no significant difference in improving the neurological functions and activities of daily living at day 90; (2) there was a remarkable decrease in case fatality by 90 days in the cranipuncture group, with statistically significant difference between the two groups (chi(2)=5.35, p=0.02); (3) the re-bleeding rate in cranipuncture group was 8.8%, significantly (chi(2)=9.51, p=0.002) lower than 21.4% in the craniotomy group. CONCLUSION: The craniopuncture combined with urokinase infusion therapy could reduce the rate of re-bleeding after surgery and the case fatality by 90 days. It also could improve the activities of daily living (Barthel index >or=95) at day 90. Thus, this therapy was a safe and practical technique in treating cerebral hemorrhage (30-80 ml), especially suitable for hospitals in rural areas or developing countries.
Authors: Daniel F Hanley; Richard E Thompson; Michael Rosenblum; Gayane Yenokyan; Karen Lane; Nichol McBee; Steven W Mayo; Amanda J Bistran-Hall; Dheeraj Gandhi; W Andrew Mould; Natalie Ullman; Hasan Ali; J Ricardo Carhuapoma; Carlos S Kase; Kennedy R Lees; Jesse Dawson; Alastair Wilson; Joshua F Betz; Elizabeth A Sugar; Yi Hao; Radhika Avadhani; Jean-Louis Caron; Mark R Harrigan; Andrew P Carlson; Diederik Bulters; David LeDoux; Judy Huang; Cully Cobb; Gaurav Gupta; Ryan Kitagawa; Michael R Chicoine; Hiren Patel; Robert Dodd; Paul J Camarata; Stacey Wolfe; Agnieszka Stadnik; P Lynn Money; Patrick Mitchell; Rosario Sarabia; Sagi Harnof; Pal Barzo; Andreas Unterberg; Jeanne S Teitelbaum; Weimin Wang; Craig S Anderson; A David Mendelow; Barbara Gregson; Scott Janis; Paul Vespa; Wendy Ziai; Mario Zuccarello; Issam A Awad Journal: Lancet Date: 2019-02-07 Impact factor: 79.321