Bloodletting Puncture in the Treatment of Acute Ischemic Stroke (NCT05266326) | Clinical Trial Compass
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Bloodletting Puncture in the Treatment of Acute Ischemic Stroke
China360 participantsStarted 2022-03-08
Plain-language 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 special treatment for acute ischemic stroke, it has been used clinically in hospitals of traditional Chinese medicine in China for many years and has achieved certain efficacy. However, there is a lack of comprehensive and objective clinical observation and mechanism research on this treatment method, as well as a lack of scientific efficacy evaluation standards and technical specifications. Therefore, we planned to explore the effectiveness, safety and accessibility of bloodletting puncture in the treatment of acute ischemic stroke through a mixed-method study of a multi-center randomised controlled trial and focus group.
Who can participate
Age range40 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. According to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, the patient is clinically diagnosed as acute ischemic stroke;
✓. The subject or his/her guardian participates voluntarily and signs the ICF.
Exclusion criteria
✕. 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;
What they're measuring
1
The National Institutes of Health Stroke Scale（NIHSS）score 7 days after bloodletting puncture treatment
Timeframe: 7 days after the start of bloodletting puncture treatment
Trial details
NCT IDNCT05266326
SponsorChongqing Traditional Chinese Medicine Hospital
. 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;