China Research for Severe Spontaneous Intracerebral Hemorrhage（CRISIH）

Status Recruiting

Clinical Trial Summary

Background: Despite the capability of emergency surgery to reduce the mortality of severe spontaneous intracranial hemorrhage (SSICH) patients, the effect and safety of surgical treatment for severe spontaneous intracranial hemorrhage (SSICH) patients receiving long-term oral antiplatelet treatment (LOAPT) remains unclear. In consideration of this, the cohort study is aimed at figuring out the effect and safety of emergency surgery for SSICH patients on LOAPT. Methods: As a multicenter and prospective cohort study, it will be conducted across 7 representative clinical centers. Starting in September 2019, the observation is scheduled to be completed by December 2022, with a total of 450 SSICH patients recruited. The information on clinical, radiological, and laboratory practices will be recorded objectively. All of the patients will be monitored until death or 6 months after the occurrence of primary hemorrhage. Study Design: In this study, two comparative cohorts and an observational cohort will be set up. The primary outcome is the effect of emergency surgery, which is subject to assessment using the total mortality and comparison in the survival rate of SSICH patients on LOAPT between surgical treatment and conservative treatment. The second outcome is the safety of surgery, with the postoperative hemorrhagic complication which is compared between the operated SSICH patients on and not on LOAPT. Based on the observation of the characteristics and outcome of SSICH patients on LOAPT, the ischemic events after discontinuing LOAPT will be further addressed, and the coagulation function assessment system for operated SSICH patients on LOAPT will be established. Objective: In this study, investigators will estimate the effect and safety of emergency surgery for SSICH patients on LOAPT, which will provide an evidence for management in the future.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05975398
Study type	Observational [Patient Registry]
Source	Beijing Tiantan Hospital
Contact	Shuo Wang
Phone	+86 13801180330
Email	captain9858@126.com
Status	Recruiting
Phase
Start date	July 1, 2022
Completion date	December 31, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02246153` - Laparoscopy-assisted and Open Distal Gastrectomy for Gastric Cancer in the Elderly Patients	Phase 3
Recruiting	`NCT02228473` - Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort	N/A
Recruiting	`NCT01917253` - Standard Length Catheters vs Long Catheters in Peripheral Vein Cannulation.	N/A
Completed	`NCT02245854` - Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps	N/A
Completed	`NCT01574196` - Assessment of Cardiac Autonomic Function in Adulthood After Chemotherapy or Radiotherapy in Childhood	N/A
Completed	`NCT02447523` - The Impact of Metabolic Syndrome on Patients Undergoing Elective Laparotomy	N/A
Terminated	`NCT00616824` - The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction	Phase 4
Completed	`NCT04061655` - Effect of Intravenous Iron Supplementation in Reducing Allogenic Blood Transfusion	Early Phase 1
Recruiting	`NCT03984747` - Study for the Prediction of Active Rejection in Organs Using Donor-derived Cell-free DNA Detection
Completed	`NCT03641365` - Sleeves Versus Sleeveless Template	N/A
Completed	`NCT02901665` - Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes	N/A
Completed	`NCT02675166` - Getting Long-term Management of Adult Children Cured of Childhood Cancer in Rhône-Alpes
Not yet recruiting	`NCT02252445` - Propofol and Sevoflurane for Catheter-Related Bladder Discomfort	N/A
Completed	`NCT01997658` - Preoperative Glucocorticoid Use in Major Hepatectomy	Phase 2/Phase 3
Active, not recruiting	`NCT01775150` - Saving Mother and Baby With Text Messaging	N/A
Completed	`NCT01631799` - Outcome of Patients After Total Knee Replacement: A Comparison of Femoral Nerve Block and Epidural Anesthesia	N/A
Completed	`NCT03440138` - Defining Benchmarks in Bariatric Surgery
Recruiting	`NCT02835404` - Pelvic External Combined With 252-Cf Neutron Intracavitary Radiotherapy With or Without Platinum in Treating Advanced Cervical Cancer	Phase 2
Completed	`NCT01489800` - The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer	N/A
Completed	`NCT02096224` - Sevoflurane Versus Desflurane for Catheter-related Bladder Discomfort	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.