A Randomized Controlled Trial of Exhaustive Drainage Versus Fixed-time Drainage for Chronic Subdural Hematoma After One-burr Hole Craniostomy

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A prospective, multicenter, randomized controlled trial is designed to compare the recurrence rates and clinical outcomes in patients with chronic subdural hematoma using exhaustive drainage or fixed-time drainage after one-burr hole craniostomy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: No
View:

• Patient (18 years to 90 years) presenting with clinical symptoms and neurological deficits of chronic subdural hematoma

• Chronic subdural hematoma verified on cranial computed tomography or magnetic resonance imaging

• Written informed consent from patients or their next of kin according to the patient's cognitive status

Locations
Other Locations
China
Beijing Chaoyang Hospital, Capital Medical University
Recruiting
Beijing
Beijing Ditan Hospital, Capital Medical University
Recruiting
Beijing
Beijing Luhe Hospital, Capital Medical University
Recruiting
Beijing
Beijing Tiantan Hospital, Capital Medical University
Recruiting
Beijing
Beijing Tongren Hospital, Capital Medical University
Recruiting
Beijing
Beijing Xuanwu Hospital, Capital Medical University
Recruiting
Beijing
Wangjing Hospital, China Academy of Chinese Medical Sciences
Not yet recruiting
Beijing
Wei County Hospital of Traditional Chinese Medicine
Recruiting
Handan
Hengshui People's Hospital
Not yet recruiting
Hengshui
First People's Hospital of Lianyungang
Recruiting
Lianyungang
The Second Nanning People's Hospital
Recruiting
Nanning
Puning People's Hospital
Recruiting
Puning
First Hospital of Qinhuangdao
Recruiting
Qinhuangdao
North China University of Science and Technology Affiliated Hospital
Not yet recruiting
Tangshan
Tianjin Huanhu Hospital
Recruiting
Tianjin
Yancheng Third People's Hospital
Recruiting
Yancheng
People's Hospital of Ningxia Hui Autonomous Region
Recruiting
Yinchuan
Xinxing County People's Hospital
Recruiting
Yunfu
Xiahuayuan District Hospital
Recruiting
Zhangjiakou
Contact Information
Primary
Liang Wu, MD
wuliang@bjtth.org
15001333582
Backup
Yuwei Ou, MD
ouyunwei@sina.com
15810549287
Time Frame
Start Date: December 29, 2020
Estimated Completion Date: May 31, 2023
Participants
Target number of participants: 304
Treatments
Active Comparator: Fixed-time drainage
Drainage will be removed after 48 hours.
Experimental: Exhaustive drainage
Drainage will be removed when postoperative hematoma volume is minimized with repeated urokinase injection into hematoma cavity through catheter.
Sponsors
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov

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