- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05266326
Bloodletting Puncture in the Treatment of Acute Ischemic Stroke
Bloodletting Puncture in the Treatment of Acute Ischemic Stroke: a Mixed-method Study of a Multi-centre Randomised Controlled Trial and Focus Group
Study Overview
Status
Conditions
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, 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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jun Tang
- Phone Number: 13709482548
- Email: Cqszyy_Tangjun2021@163.com
Study Contact Backup
- Name: Zixiu Zeng
- Phone Number: 15116996525
- Email: zengzixiu1991@163.com
Study Locations
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-
State
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Chongqing, State, China, 400021
- Recruiting
- Chongqing Traditional Chinese Medicine Hospital
-
Contact:
- Jun Tang
- Phone Number: 13709482548
- Email: Cqszyy_Tangjun2021@163.com
-
Contact:
- Zixiu Zeng
- Phone Number: 151 1699 6525
- Email: zengzixiu1991@163.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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;
- 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 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Test group
conventional Western medical treatment + bloodletting puncture
|
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.
|
Other: Control group
conventional Western medical treatment.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The National Institutes of Health Stroke Scale(NIHSS)score 7 days after bloodletting puncture treatment
Time Frame: 7 days after the start of 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.
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7 days after the start of bloodletting puncture treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 7, 14 and 30 days after the start of bloodletting puncture
|
0-42; higher scores mean a worse outcome.
|
7, 14 and 30 days after the start of bloodletting puncture
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The value of change in Glasgow Coma Scale (GCS) score from baseline at 7, 14 and 30 days after the start of bloodletting puncture
Time Frame: 7, 14 and 30 days after the start of bloodletting puncture
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3-15; the lower the score means the greater the impairment of consciousness
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7, 14 and 30 days after the start of bloodletting puncture
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The value of change in modified Rankin Scale (mRS) score from baseline at 7, 14 and 30 days after the start of bloodletting puncture
Time Frame: 7, 14 and 30 days after the start of bloodletting puncture
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0-5;the higher the score means the greater the degree of disability
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7, 14 and 30 days after the start of bloodletting puncture
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The incidence of new vascular events within 30 days after the start of bloodletting puncture
Time Frame: 30 days after the start of bloodletting puncture
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ischemic stroke, hemorrhagic stroke, myocardial infarction, and cardio-cerebral revascularization
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30 days after the start of bloodletting puncture
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All-cause mortality 30 days after the start of administration
Time Frame: 30 days after the start of bloodletting puncture
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All-cause deaths within 30 days / (total number of people in each group) x 100%
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30 days after the start of bloodletting puncture
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The number of adverse events/serious adverse events reported by the investigator throughout the study period
Time Frame: 7 days after the start of bloodletting puncture
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Significant abnormalities in vital signs, blood count, urine count, liver function, kidney function
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7 days after the start of bloodletting puncture
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Semi-structured interviews
Time Frame: 7 days after the start of bloodletting puncture
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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
|
7 days after the start of bloodletting puncture
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Collaborators and Investigators
Investigators
- Study Chair: Jun Tang, Chongqing Traditional Chinese Medicine Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019XZZX-NB014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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