NCT05266326

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

March 8, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

December 12, 2021

Last Update Submit

April 21, 2022

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic StrokeBloodletting punctureAcupunctureTraditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    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

    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

    30 days after the start of bloodletting puncture

  • All-cause mortality 30 days after the start of administration

    30 days after the start of bloodletting puncture

  • +2 more secondary outcomes

Study Arms (2)

Test group

OTHER

conventional Western medical treatment + bloodletting puncture

Other: Western medicine conventional treatment +Bloodletting punctureOther: Western medicine conventional treatment

Control group

OTHER

conventional Western medical treatment.

Other: Western medicine conventional treatment

Interventions

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.

Test group
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.

Control groupTest group

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chongqing Traditional Chinese Medicine Hospital

Chongqing, State, 400021, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jun Tang

    Chongqing Traditional Chinese Medicine Hospital

    STUDY CHAIR

Central Study Contacts

Jun Tang

CONTACT

13709482548Cqszyy_Tangjun2021@163.com

Zixiu Zeng

CONTACT

15116996525zengzixiu1991@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2021

First Posted

March 4, 2022

Study Start

March 8, 2022

Primary Completion

December 1, 2022

Study Completion

December 31, 2022

Last Updated

April 22, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)