Immune Thrombocytopenia (ITP)NCT07070193
Longitudinal Cohort Study on Immune Thrombocytopenia Complicated With Acute Ischemic Stroke
An observational study of Immune Thrombocytopenia (ITP) and Acute Ischemic Stroke, run by Peking University People's Hospital.
Trial summary
Immune thrombocytopenia (ITP) is an acquired bleeding disorder mediated by immune-related platelet destruction and impaired platelet production. Immune thrombocytopenia may increase the risk of cerebral infarction and represents a relatively uncommon etiology of acute ischemic stroke. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Immune Thrombocytopenia (ITP), Acute Ischemic Stroke
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2025to 31 Dec 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with confirmed immune thrombocytopenia (ITP) combined with acute ischemic stroke（AIS) Diagnostic Criteria for ITP: 1. Sustained platelet count <100×10⁹/L 2. Normal or increased megakaryocyte count in bone marrow with maturation defects 3. Exclusion of other potential causes of thrombocytopenia including: pseudothrombocytopenia, drug-induced thrombocytopenia, viral infections, helicobacter pylori infection, hematologic disorders, autoimmune diseases, hypersplenism, malignancies Diagnostic Criteria for AIS: 1. Acute onset; 2. Focal neurological deficits (weakness or numbness of one side of the face or limb, language disorders, etc.), with a few cases presenting with comprehensive neurological deficits; 3. The presence of a responsible lesion on imaging or the symptoms/signs persisting for more than 24 hours; 4. Elimination of non-vascular causes; 5. Brain CT/MRI ruling out cerebral hemorrhage.
Who may be able to join
- Diagnosed with immune thrombocytopenia, and subsequently identified patients with acute ischemic stroke.
- Since January 1, 2005, patients who received treatment at Peking University People's Hospital.
Who cannot join
- For any reason, such as the occurrence of severe mental disorders, the follow-up information may be unavailable;
- Patients deemed unsuitable for the study by the researchers.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Retrospective and Prospective Longitudinal Observational Study on Immune Thrombocytopenia Complicated With Acute Ischemic Stroke
Immune thrombocytopenia (ITP) is an acquired bleeding disorder mediated by immune-related platelet destruction and impaired platelet production. Immune thrombocytopenia may increase the risk of cerebral infarction and represents a relatively uncommon etiology of acute ischemic stroke. This disease is associated with high disability and mortality rates, poses significant therapeutic challenges, and constitutes a serious threat to human health. Therefore, research on the diagnosis, treatment, and prognosis of ITP combined with acute ischemic stroke is of great significance for improving patients' quality of life and survival outcomes. However, most current hematologic cohort studies are based on single-center or limited multicenter sample sizes, lacking comprehensive and large-scale prospective cohort studies. Our center plans to conduct a large-sample, combined retrospective and prospective longitudinal cohort study. This study will register patients' basic information and diagnosis, follow up with patients through questionnaires, telephone calls, video consultations, online platforms, and in-person visits to record treatment and comorbidity data, collect prognostic information, and retrieve hospitalization and outpatient costs through medical record systems. The study aims to provide comprehensive data on the incidence, treatment, prognosis, and healthcare costs of ITP patients with acute ischemic stroke in China.
Read the detailed description
Immune thrombocytopenia (ITP) is an immune-mediated acquired bleeding disorder characterized by thrombocytopenia, with normal or increased megakaryocyte counts in the bone marrow but impaired maturation. The estimated incidence in the general population is approximately 2 to 5 cases per 100,000 individuals. The primary clinical manifestation of ITP is bleeding, ranging from mild skin/mucosal bleeding to life-threatening organ hemorrhage. However, some patients also face an increased risk of thrombosis/embolism. Embolic events in critical organs such as the heart and brain can severely impact patients' quality of life and lead to life-threatening complications.
In China, there are approximately 3.94 million new stroke cases annually, of which acute ischemic stroke (AIS) is the most common type, accounting for 69.6% to 72.8% of all new stroke cases. From an epidemiological perspective, AIS is a globally prevalent disease that significantly affects the quality of life and physical health across populations.
Research indicates that immune thrombocytopenia increases the risk of cerebral infarction and represents a relatively uncommon but important etiological factor for acute ischemic stroke. Currently, most cohort studies on ITP in China are either single-center studies or limited multicenter studies with small sample sizes, resulting in insufficient data and a lack of large-scale, longitudinal prospective cohort studies.
This study is a multicenter, retrospective and prospective longitudinal observational study that will enroll patients diagnosed with ITP and concurrent acute ischemic stroke. It will collect baseline patient information and diagnostic data, conduct regular prospective follow-ups via questionnaires, telephone interviews, video consultations, online platforms, and in-person visits, and record treatment regimens, comorbidities, and prognostic outcomes. Additionally, hospitalization and outpatient costs will be extracted from medical records. The study aims to provide comprehensive data on the epidemiology, treatment patterns, clinical outcomes, and healthcare costs of ITP patients with AIS in China, ultimately supporting the development of novel diagnostic and therapeutic strategies and improving long-term bleeding-free survival rates.
- Keywords
- Immune Thrombocytopenia, Acute Ischemic Stroke
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | Patients whose first visit to our institution and the termination of follow-up both occurred before the opening of this study will contribute to the retrospective cohort. | |
| Prospective cohort | Patients whose first visit to our institution occur after the opening of this study will contribute to the prospective cohort. | |
| Retrospective/Prospective cohort | Patients whose first visit to our institution occurred before the opening of this study and whose follow-up will terminate after the opening of this study will contribute to the ambispective cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognosis
To analyze the long-term prognosis of patients with immune thrombocytopenia (ITP) combined with acute ischemic stroke, and analyze the risk factors associated with their prognosis.
Measured: 5 years
Secondary outcomes (6)
Overall response rate
To analyze the therapeutic efficacy of patients with ITP with AIS, and analyze the impact factors associated with the efficacy.
Measured: 180 days
Long-term overall remission rate
Proportion of the participants with an overall remission.
Measured: 1 year
Comorbidities
The incidence, risk factors, treatments, and prognosis of complications
Measured: 5 years
Incidence
To describe the incidence of ITP and AIS, and analyze the risk factors associated with these diseases.
Measured: 5 years
Safety of treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: 1 year
Health economic evaluation
To perform hospital stay and hospitalization cost evaluation in patients with thrombosis and hemostasis diseases
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start10 Jul 2025 (estimated)
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenia (ITP)Studies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu province hospital of TCM, Army Medical University, China, Henan Cancer Hospital, The Affiliated People's Hospital of Ningbo University, West China Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital of Zhejiang University, The Second Hospital of Hebei Medical University, Kunming Medical University Second Affiliated Hospital, Shanghai Zhongshan Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Huazhong Science & Technology Shanxi Baiqiu En Hospital, Northern Jiangsu People's Hospital, Tongji Hospital, Xuzhou Medical University Affiliated Hospital of Huaian, Affiliated Hospital of Fujian Medical University, Xiehe Branch, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First Affiliated Hospital of Guangxi Medical University, The Third Xiangya Hospital of Central South University, Second Xiangya Hospital of Central South University, Xiangya Hospital of Central South University, Qilu Hospital of Shandong University, Southern Medical University, China, The First Affiliated Hospital of University of Science and Technology of China, The First Affiliated Hospital of Nanchang University, First Affiliated Hospital of Xinjiang Medical University, North China University of Science and Technology
- Responsible party
- Principal investigator, Xiao Hui Zhang, Peking University People's Hospital
- Investigators
- Xiao-Hui Zhang, MD, Principal investigator, eking University Institute of Hematology, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070193
- Sponsor's protocol ID
- ITP-AIS2025
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective Longitudinal Observational Study on Immune Thrombocytopenia Complicated With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07070193
- Acronym / sponsor ID
- ITP-AIS2025
- Keywords
- Immune Thrombocytopenia, Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Jiangsu province hospital of TCM, Army Medical University, China, Henan Cancer Hospital, The Affiliated People's Hospital of Ningbo University, West China Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital of Zhejiang University, The Second Hospital of Hebei Medical University, Kunming Medical University Second Affiliated Hospital, Shanghai Zhongshan Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Huazhong Science & Technology Shanxi Baiqiu En Hospital, Northern Jiangsu People's Hospital, Tongji Hospital, Xuzhou Medical University Affiliated Hospital of Huaian, Affiliated Hospital of Fujian Medical University, Xiehe Branch, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First Affiliated Hospital of Guangxi Medical University, The Third Xiangya Hospital of Central South University, Second Xiangya Hospital of Central South University, Xiangya Hospital of Central South University, Qilu Hospital of Shandong University, Southern Medical University, China, The First Affiliated Hospital of University of Science and Technology of China, The First Affiliated Hospital of Nanchang University, First Affiliated Hospital of Xinjiang Medical University, North China University of Science and Technology
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 17 Jul 2025 (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.
Immune thrombocytopenia (ITP) is an acquired bleeding disorder mediated by immune-related platelet destruction and impaired platelet production. Immune thrombocytopenia may increase the risk of cerebral infarction and represents a relatively uncommon etiology of acute ischemic stroke. This disease is associated with high disability and mortality rates, poses significant therapeutic challenges, and constitutes a serious threat to human health. Therefore, research on the diagnosis, treatment, and prognosis of ITP combined with acute ischemic stroke is of great significance for improving patients' quality of life and survival outcomes. However, most current hematologic cohort studies are based on single-center or limited multicenter sample sizes, lacking comprehensive and large-scale prospective cohort studies. Our center plans to conduct a large-sample, combined retrospective and prospective longitudinal cohort study. This study will register patients' basic information and diagnosis, follow up with patients through questionnaires, telephone calls, video consultations, online platforms, and in-person visits to record treatment and comorbidity data, collect prognostic information, and retrieve hospitalization and outpatient costs through medical record systems. The study aims to provide comprehensive data on the incidence, treatment, prognosis, and healthcare costs of ITP patients with acute ischemic stroke in China.
Detailed description
Immune thrombocytopenia (ITP) is an immune-mediated acquired bleeding disorder characterized by thrombocytopenia, with normal or increased megakaryocyte counts in the bone marrow but impaired maturation. The estimated incidence in the general population is approximately 2 to 5 cases per 100,000 individuals. The primary clinical manifestation of ITP is bleeding, ranging from mild skin/mucosal bleeding to life-threatening organ hemorrhage. However, some patients also face an increased risk of thrombosis/embolism. Embolic events in critical organs such as the heart and brain can severely impact patients' quality of life and lead to life-threatening complications.
In China, there are approximately 3.94 million new stroke cases annually, of which acute ischemic stroke (AIS) is the most common type, accounting for 69.6% to 72.8% of all new stroke cases. From an epidemiological perspective, AIS is a globally prevalent disease that significantly affects the quality of life and physical health across populations.
Research indicates that immune thrombocytopenia increases the risk of cerebral infarction and represents a relatively uncommon but important etiological factor for acute ischemic stroke. Currently, most cohort studies on ITP in China are either single-center studies or limited multicenter studies with small sample sizes, resulting in insufficient data and a lack of large-scale, longitudinal prospective cohort studies.
This study is a multicenter, retrospective and prospective longitudinal observational study that will enroll patients diagnosed with ITP and concurrent acute ischemic stroke. It will collect baseline patient information and diagnostic data, conduct regular prospective follow-ups via questionnaires, telephone interviews, video consultations, online platforms, and in-person visits, and record treatment regimens, comorbidities, and prognostic outcomes. Additionally, hospitalization and outpatient costs will be extracted from medical records. The study aims to provide comprehensive data on the epidemiology, treatment patterns, clinical outcomes, and healthcare costs of ITP patients with AIS in China, ultimately supporting the development of novel diagnostic and therapeutic strategies and improving long-term bleeding-free survival rates.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | –Patients whose first visit to our institution and the termination of follow-up both occurred before the opening of this study will contribute to the retrospective cohort. |
| Prospective cohort | – | –Patients whose first visit to our institution occur after the opening of this study will contribute to the prospective cohort. |
| Retrospective/Prospective cohort | – | –Patients whose first visit to our institution occurred before the opening of this study and whose follow-up will terminate after the opening of this study will contribute to the ambispective cohort. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with confirmed immune thrombocytopenia (ITP) combined with acute ischemic stroke（AIS) Diagnostic Criteria for ITP: 1. Sustained platelet count <100×10⁹/L 2. Normal or increased megakaryocyte count in bone marrow with maturation defects 3. Exclusion of other potential causes of thrombocytopenia including: pseudothrombocytopenia, drug-induced thrombocytopenia, viral infections, helicobacter pylori infection, hematologic disorders, autoimmune diseases, hypersplenism, malignancies Diagnostic Criteria for AIS: 1. Acute onset; 2. Focal neurological deficits (weakness or numbness of one side of the face or limb, language disorders, etc.), with a few cases presenting with comprehensive neurological deficits; 3. The presence of a responsible lesion on imaging or the symptoms/signs persisting for more than 24 hours; 4. Elimination of non-vascular causes; 5. Brain CT/MRI ruling out cerebral hemorrhage.
Key inclusion criteria (2 listed)
- Diagnosed with immune thrombocytopenia, and subsequently identified patients with acute ischemic stroke.
- Since January 1, 2005, patients who received treatment at Peking University People's Hospital.
Key exclusion criteria (2 listed)
- For any reason, such as the occurrence of severe mental disorders, the follow-up information may be unavailable;
- Patients deemed unsuitable for the study by the researchers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prognosis
Time frame: 5 years
To analyze the long-term prognosis of patients with immune thrombocytopenia (ITP) combined with acute ischemic stroke, and analyze the risk factors associated with their prognosis.
6 secondary outcomes
Overall response rate
Time frame: 180 days
Long-term overall remission rate
Time frame: 1 year
Comorbidities
Time frame: 5 years
Incidence
Time frame: 5 years
Safety of treatment
Time frame: 1 year
Health economic evaluation
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
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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.
Xiao-Hui Zhang, MD principal investigator
eking University Institute of Hematology, Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Thrombocytopenia (ITP) and Acute Ischemic Stroke, run by Peking University People's Hospital.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li-Qin Cao, MD (086-01088326002, caoliqin@pkuph.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognosis (time frame: 5 years). 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 17 Jul 2025.