scholarly journals Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trial

2020 ◽  
Author(s):  
Junhao Zhu ◽  
Chao Tang ◽  
Zixiang Cong ◽  
Jin Yang ◽  
Xiangming Cai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intraventricular Hemorrhage ◽  
Controlled Trial ◽  
External Ventricular Drainage ◽  
Primary Objective ◽  
Controlled Clinical Trial ◽  
Ventricular Drainage ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Tertiary Hospitals

Abstract Background The application of neuroendoscopy in intraventricular hemorrhage (IVH) has attracted more and more attention in recent years. Studies have shown that the use of neuroendoscopy for IVH evacuation has advantages over external ventricular drainage (EVD) alone. However, the cases of most current research are small and all of them are retrospective studies. The aim of this study is to explore the prognosis of patients with moderate to severe IVH who undergo endoscopic IVH evacuation surgery versus those who undergo EVD alone. Methods The study is a prospective, randomized, controlled, multi-center clinical trial. Nine hundred and fifty-six subjects with moderate to severe IVH across four tertiary hospitals in China will be randomly assigned (1:1) to receive either endoscopic IVH evacuation surgery or EVD. The primary objective is to compare patients’ survival rate at 12 months postoperatively. Discussion The trial is designed to investigate the prognostic benefits of endoscopic IVH evacuation surgery for patients with moderate to severe IVH. Currently, it has never been investigated in a prospective randomized controlled clinical trial.

scholarly journals Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trial

2020 ◽  
Author(s):  
Junhao Zhu ◽  
Chao Tang ◽  
Zixiang Cong ◽  
Jin Yang ◽  
Xiangming Cai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intraventricular Hemorrhage ◽  
Controlled Trial ◽  
External Ventricular Drainage ◽  
Primary Objective ◽  
Controlled Clinical Trial ◽  
Ventricular Drainage ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Tertiary Hospitals

Abstract Background: The application of neuroendoscopy in intraventricular hemorrhage (IVH) has attracted more and more attention in recent years. Studies have shown that the use of neuroendoscopy for IVH evacuation has advantages over external ventricular drainage (EVD) alone. However, the cases of most current research are small and all of them are retrospective studies. The aim of this study is to explore the prognosis of patients with moderate to severe IVH who undergo endoscopic IVH evacuation surgery versus those who undergo EVD alone.Methods: The study is a prospective, randomized, controlled, multi-center clinical trial. Nine hundred and fifty-six subjects with moderate to severe IVH across four tertiary hospitals in China will be randomly assigned (1:1) to receive either endoscopic IVH evacuation surgery or EVD. The primary objective is to compare patients’ survival rate at 12 months after surgery.Discussion: The trial is designed to investigate the prognostic benefits of endoscopic IVH evacuation surgery for patients with moderate to severe IVH. Currently, it has never been investigated in a prospective randomized controlled clinical trial.Trial registration: ClinicalTrials.gov, NCT04037267. Registered on 26 July 2019.

scholarly journals Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trial

2019 ◽  
Author(s):  
Junhao Zhu ◽  
Chao Tang ◽  
Zixiang Cong ◽  
Jin Yang ◽  
Xiangming Cai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intraventricular Hemorrhage ◽  
Controlled Trial ◽  
External Ventricular Drainage ◽  
Primary Objective ◽  
Controlled Clinical Trial ◽  
Ventricular Drainage ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Tertiary Hospitals

Abstract Background The application of neuroendoscopy in intraventricular hemorrhage (IVH) has attracted more and more attention in recent years. Studies have shown that the use of neuroendoscopy for IVH evacuation has advantages over external ventricular drainage (EVD) alone. However, the cases of most current research are small and all of them are retrospective studies. The aim of this study is to explore the prognosis of patients with moderate to severe IVH who undergo endoscopic IVH evacuation surgery versus those who undergo EVD alone.Methods The trial is a prospective, randomized, controlled, multi-center clinical trial. Nine hundred and fifty-six subjects with moderate to severe IVH across four tertiary hospitals in China will be randomly assigned (1:1) to receive either endoscopic IVH evacuation surgery or EVD. The primary objective is to compare patients’ survival rate at 12 months postoperatively after the two approaches.Discussion The trial is designed to investigate the prognostic benefits of endoscopic IVH evacuation surgery for patients with moderate to severe IVH. Currently, it has never been investigated in a prospective randomized controlled clinical trial.

scholarly journals Rapid Pore Cranial Drilling With External Ventricular Drainage for Treatment of Intraventricular Hemorrhage: A 36-Year Case Series

2015 ◽  
Vol 100 (6) ◽  
pp. 1117-1123 ◽  
Author(s):  
Wei Zhang ◽  
Lin Wei ◽  
Gang Li ◽  
Jinlong Sun ◽  
Peng Jin ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Intraventricular Hemorrhage ◽  
Blood Clot ◽  
Controlled Trial ◽  
Case Series ◽  
External Ventricular Drainage ◽  
Therapeutic Effects ◽  
Ventricular Drainage ◽  
Drilling Technique ◽  
Conventional Drilling

This study aimed to describe the technique details of rapid pore cranial drilling with external ventricular drainage and document its clinical outcomes by highlighting the advantages over the traditional and modified cranial drilling technique. Intraventricular hemorrhage is one of the most severe subtypes of hemorrhagic stroke with high mortality. The amount of blood in the ventricles is associated with severity of outcomes, and fast removal of the blood clot is the key to a good prognosis. Between 1977 and 2013, 3773 patients admitted for intraventricular hemorrhage underwent rapid pore cranial drilling drainage. The therapeutic effects and clinical outcomes were retrospectively analyzed. Of these patients, 1049 (27.8%) experienced complete remission, 1788 (47.4%) had improved condition, and 936 (24.8%) died. A total of 3229 (85.6%) patients gained immediate remission. One typical case was illustrated to demonstrate the efficacy of the rapid pore drilling technique. Rapid pore cranial drilling drainage in patients with intraventricular hemorrhage is fast, effective, and provides immediate relief in patients with severe conditions. It could be a better alternative to the conventional drilling approach for treatment of intraventricular hemorrhage. A randomized controlled trial for direct comparison between the rapid pore cranial drilling drainage and conventional drilling technique is in urgent need.

scholarly journals Baidu Jieduan granule, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial

2020 ◽  
Author(s):  
Wen Zhang ◽  
Qin Xie ◽  
Xiaoming Xu ◽  
Shuting Sun ◽  
Tian Fan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Controlled Trial ◽  
Theory And Practice ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled

Abstract Background: Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive impact on human health. Due to the absence of antiviral medicine for COVID-19 thus far, it is desperately need to develop the effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, hoping to produce clinical efficacy and decrease the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Baidu Jieduan granule in curing COVID-19. Methods/design: This multicenter, open-label randomized controlled trial is conducted 300 cases with COVID-19. The patients will be randomly (1:1) divided into treatment group or control group. All cases will receive standard therapy at the same time. The experiment group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes are assessed at baseline and at 3, 5, 7, 14 days after treatment initiation. The primary outcome is the rate of symptom (fever, fatigue, and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial.Discussion: The study will provide a high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granule in treatment of moderate COVID-19, and also enrich the theory and practice of TCM in treating COVID-19. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029869. Registered on 15 February 2020

scholarly journals GnRHa vs. observation in the treatment of multiple leiomyomas after myomectomy: study protocol for a multicenter, prospective, randomized controlled clinical trial

2020 ◽  
Author(s):  
Jia Wei ◽  
Xiangyi Ma ◽  
Wenwen Wang ◽  
Minli Zhang ◽  
Zhiying Yu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trials ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Gonadotropin Releasing Hormone ◽  
Controlled Clinical Trial ◽  
Releasing Hormone ◽  
Gonadotropin Releasing Hormone Agonist ◽  
Randomized Controlled ◽  
Pathological Result

Abstract Background: Recurrence of the leiomyoma is one of the major concerns of myomectomy in the long-term management, especially for the multiple leiomyomas. Gonadotropin-releasing hormone agonist (GnRHa) is currently one of the most effective medications to reduce the volume of the fibroids and the uterus. However, its role in preventing recurrence after conservative surgery remains unclear. At present, there is no evidence from randomized clinical trials comparing the efficacy between GnRHa and follow-up observation in the recurrence rate of multiple leiomyomas after myomectomy.Methods: We are conducting a randomized controlled trial in women aged 18-45 undergoing myomectomy for the multiple leiomyomas. After the surgery, women whose pathological result confirms multiple leiomyoma are randomized into two parallel groups: observation group and GnRHa group. The primary outcome is the recurrence of either clinical symptoms or imaging.Discussion: The results of this study will provide evidence for the efficacy of the gonadotropin-releasing hormone agonist in preventing the recurrence of high-risk leiomyoma after myomectomy.Trial registration: Chinese Clinical Trial Registry, ChiCTR-IPR-17012992 (http://www.chictr.org.cn/showproj.aspx?proj=21797 ). Registered on 15 Oct 2017.

scholarly journals Yiqi Fumai Injection for patients with Septic Shock: study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Bo-jun Chen ◽  
Zeng Jing ◽  
Cai Xingui ◽  
Cai Hairong ◽  
Luo Sicong ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Septic Shock ◽  
Randomized Controlled Trial ◽  
Conventional Treatment ◽  
Controlled Trial ◽  
Small Sample ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled

Abstract Background: Septic shock is an important problem in critical care medicine and one of the leading causes of death in intensive care units (ICU). In China, Traditional Chinese medicine (TCM) has been widely used as the adjuvant treatment to improve the symptoms and prognosis in patients with septic shock. Yiqi Fumai Injection (YFI) is one of the most important proprietary TCM for septic shock, previous studies have demonstrated its efficacy and safety. However, these conclusions were limited due to the small sample size and low quality of methodologies of these studies. Therefore, we designed this study to evaluate the efficacy and safety of using YFI as an adjunct treatment for septic shock.Methods/design: This is a double-blind, randomized, parallel, placebo-controlled clinical trial. A total of 800 participants will be randomly assigned to receive either treatment or placebo in a 1:1 ratio. The treatment group will receive YFI combined with conventional treatment, and the control group will receive 0.9% sodium chloride injection combined with conventional treatment for 2 weeks. The primary outcome is the 28-days mortality. Secondary outcomes are blood lactate levels, hemodynamics, blood gas analysis, immune function indicators, inflammatory indicators, acute physiology improvement and chronic health assessment (APACHE) II scores, and sepsis-related organ failure score (SOFA). Adverse events will be observed and recorded at the same time for safety assessment.Discussion: This randomized controlled trial will help evaluate the efficacy and safety of YFI for the treatment of septic shock. The results of this trial will provide recommendations for the management of septic shock.Trial registration {2a and 2b}：China Clinical Trial Registry, ChiCTR-1900026424.Registered on 15 June 2019.

Sign in / Sign up

Export Citation Format

Share Document