Status:
UNKNOWN
Bloodletting Puncture in the Treatment of Acute Ischemic Stroke
Lead Sponsor:
Chongqing Traditional Chinese Medicine Hospital
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief Summary
The bloodletting puncture is an external treatment for acute ischemic stroke by releasing an appropriate amount of blood with a three-edged needle at specific points on the patient's body. As a specia...
Detailed Description
Ischemic stroke is a common disease of nervous system, with high morbidity, mortality and disability, which seriously threatens human health. According to the latest global burden of disease research,...
Eligibility Criteria
Inclusion
- According to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, the patient is clinically diagnosed as acute ischemic stroke;
- Age 40-85, regardless of gender;
- NIHSS score: 4 ≤ screening period/baseline NIHSS score ≤ 20;
- Within 7 days of the onset;
- The subject or his/her guardian participates voluntarily and signs the ICF.
Exclusion
- Patients with transient cerebral ischaemic attack or cerebral embolism caused by brain tumour or traumatic brain injury, or acute cerebral haemorrhage or intracranial tumour;
- Patients who have received other vascular opening therapies before enrollment, such as: arterial thrombolysis, endovascular thrombectomy, angioplasty stenting, etc;
- Patients who have received thrombolytic therapy prior to enrollment, including: recombinant tissue-type fibrinogen activator (r-TPA), urokinase, etc;
- Presence of severe coagulation disorders, history of systemic bleeding;
- Fasting blood glucose \< 2.8 or \> 16.8 mmol/L or with severe complications due to diabetes (e.g. peripheral neuropathy or diabetic gangrene);
- Life expectancy of \< 3 months due to any advanced disease;
- Patients with a combination of serious primary diseases of the cardiovascular, hepatic, renal and haematopoietic systems, psychiatric disorders (including addiction and substance use disorders, dissociative disorders and schizophrenia);
- Pregnant/lactating women, or women of childbearing potential who plan to have a pregnancy during the 12-month period;
- Patients who have participated in drug or device trials within one month.
Key Trial Info
Start Date :
March 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT05266326
Start Date
March 8 2022
End Date
December 31 2022
Last Update
April 22 2022
Active Locations (1)
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1
Chongqing Traditional Chinese Medicine Hospital
Chongqing, State, China, 400021