Acute Ischemic StrokeNCT05266326
Bloodletting Puncture in the Treatment of Acute Ischemic Stroke
A study testing Western medicine conventional treatment +Bloodletting puncture and Western medicine conventional treatment in people with Acute Ischemic Stroke, run by Chongqing Traditional Chinese Medicine Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Western medicine conventional treatment +Bloodletting puncture and Western medicine conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chongqing Traditional Chinese Medicine Hospital
Chongqing, State, 400021
Jun Tang, 13709482548, Cqszyy_Tangjun2021@163.com
Zixiu Zeng, 151 1699 6525, zengzixiu1991@163.com
About this study
Official title: Bloodletting Puncture in the Treatment of Acute Ischemic Stroke: a Mixed-method Study of a Multi-centre Randomised Controlled Trial and Focus Group
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Western medicine conventional treatment +Bloodletting puncture, Western medicine conventional treatment
- Keywords
- Acute Ischemic Stroke, Bloodletting puncture, Acupuncture, Traditional Chinese Medicine
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Western medicine conventional treatment +Bloodletting punctureOther
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.
Western medicine conventional treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Other | conventional Western medical treatment + bloodletting puncture Receives: Other: Western medicine conventional treatment +Bloodletting puncture; Other: Western medicine conventional treatment |
| Control group | Other | conventional Western medical treatment. Receives: Other: Western medicine conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 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.
Measured: 7 days after the start of bloodletting puncture treatment
Secondary outcomes (7)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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%
Measured: 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
Measured: 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
Measured: 7 days after the start of bloodletting puncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start8 Mar 2022
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Traditional Chinese Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Tang, Study chair, Chongqing Traditional Chinese Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266326
- Sponsor's protocol ID
- 2019XZZX-NB014
- Status last verified
- Apr 2022
- First submitted
- 12 Dec 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bloodletting Puncture in the Treatment of Acute Ischemic Stroke: a Mixed-method Study of a Multi-centre Randomised Controlled Trial and Focus Group
- ClinicalTrials.gov ID
- NCT05266326
- Acronym / sponsor ID
- 2019XZZX-NB014
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Bloodletting puncture, Acupuncture, Traditional Chinese Medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Chongqing Traditional Chinese Medicine HospitalUniversity, hospital or other
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Other | Other: Western medicine conventional treatment +Bloodletting puncture, Other: Western medicine conventional treatmentconventional Western medical treatment + bloodletting puncture |
| Control group | Other | Other: Western medicine conventional treatmentconventional Western medical treatment. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Western medicine conventional treatment +Bloodletting punctureAll 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. | Other | Test group |
| Western medicine conventional treatmentThe 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, Test group |
Primary outcome
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.
7 secondary outcomes
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
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
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
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
All-cause mortality 30 days after the start of administration
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
Time frame: 7 days after the start of bloodletting puncture
Semi-structured interviews
Time frame: 7 days after the start of bloodletting puncture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Tang study chair
Chongqing Traditional Chinese Medicine Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Western medicine conventional treatment +Bloodletting puncture and Western medicine conventional treatment in people with Acute Ischemic Stroke, run by Chongqing Traditional Chinese Medicine Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Tang (13709482548, Cqszyy_Tangjun2021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.