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.
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, the overall lifetime risk of stroke in China is 39.9%, ranking first in the world. Intravenous thrombolysis is one of the most effective treatment methods for AIS at present. Although the recanalization rate of intravenous thrombolysis with alteplase can reach about 50%, in actual treatment, about 1/3 of patients experience reocclusion after thrombolytic therapy, resulting in neurological deterioration. The bloodletting puncture as a traditional first aid measure in Chinese medicine could improves the patient's ability to perform activities of daily living, reduces the degree of neurological deficits and facilitates the recovery of consciousness in patients with impaired awareness. However, there is a lack of comprehensive and objective clinical observation and mechanistic studies on this treatment method, as well as a lack of scientific efficacy evaluation standards and technical specifications. This is a mixed-method study of a multi-centre randomised controlled trial and focus group, and the subjects are patients with acute ischemic stroke within 72 hours of onset. This study aims to evaluate the effectiveness, safety and accessibility of bloodletting puncture in the treatment of acute ischemic stroke. Subjects who meet the inclusion criteria but do not meet the exclusion criteria are randomly divided into two groups:respectively, namely: Group 1 Test group （conventional Western medical treatment + bloodletting puncture）；Group 2 Control group （conventional Western medical treatment）.The total duration of bloodletting puncture treatment is 7 days. The patients are observed immediately after the end of bloodletting puncture treatment, 7 days after the end of bloodletting puncture treatment, and followed up to 14 days and 30 days after the start of bloodletting puncture treatment. The study endpoints included NIHSS score after 7 days of bloodletting puncture treatment (primary efficacy indicator), change from baseline values of NIHSS score, Glasgow score and mRS score after 7, 14 and 30 days of bloodletting puncture treatment (secondary efficacy indicators), stroke recurrence rate and mortality rate within 30 days (secondary efficacy indicators), and separate patients and physicians interviews at day 7 of bloodletting puncture treatment. The safety，efficacy and accessibility of bloodletting puncture in the treatment of acute ischemic stroke by statistical analysis of endpoint indicators.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
All acupoints are positioned according to the WHO standard acupuncture point locations in the Western Pacific Region. Operation: The patient is placed in a reasonable position, the acupuncture site is exposed, and the operator uses pushing, rubbing, squeezing and butterfly on or around the acupuncture site to collect blood at the acupuncture site before pricking, and then disinfects the acupuncture site with 75% ethanol. If more bleeding occurs, press with sterile dry cotton balls to stop the bleeding. The treatment was performed once daily for 7 days.
The patients in both groups were given conventional comprehensive treatment such as improving cerebral circulation, neuroprotection, antiplatelet aggregation, lipid regulation and symptomatic management after admission. Patients with hypertension, hyperglycaemia, hyperlipidaemia and coronary atherosclerotic heart disease were given individualised symptomatic treatment and advised to stop smoking, drinking alcohol and other adverse lifestyles as far as possible.
Chongqing Traditional Chinese Medicine Hospital
Chongqing, State, China
RECRUITINGThe National Institutes of Health Stroke Scale（NIHSS）score 7 days after bloodletting puncture treatment
The NIHSS is an 11-item test that assesses the degree of functional impairment caused by stroke, with scores ranging from 0 to 42; higher scores mean a worse outcome.
Time frame: 7 days after the start of bloodletting puncture treatment
The value of change in National Institutes of Health Stroke Scale (NIHSS) score from baseline at 7, 14 and 30 days after the start of bloodletting puncture
0-42; higher scores mean a worse outcome.
Time frame: 7, 14 and 30 days after the start of bloodletting puncture
The value of change in Glasgow Coma Scale (GCS) score from baseline at 7, 14 and 30 days after the start of bloodletting puncture
3-15; the lower the score means the greater the impairment of consciousness
Time frame: 7, 14 and 30 days after the start of bloodletting puncture
The value of change in modified Rankin Scale (mRS) score from baseline at 7, 14 and 30 days after the start of bloodletting puncture
0-5；the higher the score means the greater the degree of disability
Time frame: 7, 14 and 30 days after the start of bloodletting puncture
The incidence of new vascular events within 30 days after the start of bloodletting puncture
ischemic stroke, hemorrhagic stroke, myocardial infarction, and cardio-cerebral revascularization
Time frame: 30 days after the start of bloodletting puncture
All-cause mortality 30 days after the start of administration
All-cause deaths within 30 days / (total number of people in each group) x 100%
Time frame: 30 days after the start of bloodletting puncture
The number of adverse events/serious adverse events reported by the investigator throughout the study period
Significant abnormalities in vital signs, blood count, urine count, liver function, kidney function
Time frame: 7 days after the start of bloodletting puncture
Semi-structured interviews
Semi-structured interviews were conducted with the doctors and patients participating in this study, to analyse the factors influencing the acceptance and feasibility of the implementation of the blood pricking method during the study
Time frame: 7 days after the start of bloodletting puncture
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