Treatments and Outcomes of Untreated Cerebral Cavernous Malformations in CHina. (TOUCH)
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|ClinicalTrials.gov Identifier: NCT03467295|
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : March 19, 2018
|Condition or disease||Intervention/treatment|
|Cerebral Cavernous Malformations||Procedure: Surgery Procedure: Observation|
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Treatments and Outcomes of Untreated Cerebral Cavernous Malformations in CHINA (TOUCH): A Nationwide Multicenter Prospective Cohort Study.|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||March 31, 2023|
|Estimated Study Completion Date :||March 31, 2023|
Surgically treated group
Surgical removal of intracerebral CMs by craniotomy with or without following stereotactic radiosurgery.
For patient in surgically treated group, surgical removal of intracerebral CMs by craniotomy is performed according to the principles as follows: less transgression of normal brain tissue; identification and protection of eloquent brain tissue; sparing associated developmental venous anomaly; hemosiderin rim resection for non-eloquent and superficial CMs and sparing yellowish tissue for eloquent and deep ones; Extended resections (mesial resection, standard temporal lobe resection) are recommend for epileptogenic CMs based on intra-operative EEG.
Conservatively treated group
Observation with the best medicine administration and supportive treatment are performed.
Observation is performed in conservatively treated patients with best medicine and supportive treatment, such as antiepileptic drugs, analgesic drugs and neurotrophic drugs. For patients with underlying diseases such as hypertension, hyperlipidemia or diabetes mellitus, after consulting with the relevant experts, the patients can be treated accordingly.
- Poor outcome [ Time Frame: 3 years ]The primary outcome of this study is patients with poor outcome (mRS>2 lasting at least 1year) at the last follow up.
- symptomatic hemorrhage [ Time Frame: 3 years ]Requiring acute or subacute onset symptoms (any of headache, epileptic seizure, impaired consciousness, or new/worsened brain function deficit referable to the anatomic location of the CM) accompanied by radiological, pathological, surgical, or rarely only cerebrospinal fluid evidence of recent extra- or intralesional hemorrhage.
- drug refractory epilepsy [ Time Frame: 3 years ]Failure of adequate trials of two tolerated, appropriately chosen and used antiepileptic drug schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
- All-cause mortality [ Time Frame: 3 years ]Death caused by all the causes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467295
|Contact: Fuxin Lin, MDfirstname.lastname@example.org|
|Contact: Dezhi Kang, MD,PHDemail@example.com|
|The first affiliated hospital of fujian medical university||Recruiting|
|Fuzhou, Fujian, China, 350005|
|Contact: Fuxin Lin, MD 13552358381 firstname.lastname@example.org|
|Principal Investigator: Dezhi Kang, PHD,MD|
|Sub-Investigator: Fuxin Lin, MD|
|Study Chair:||Dezhi Kang, MD,PHD||First Affiliated Hospital of Fujian Medical University|