Thrombocytopenia; DrugsPhase 4NCT04915287
Efficacy of Avatrombopag in Thrombocytopenic Patients With Chronic Liver Disease Undergoing an Elective Procedure
A Phase 4 study testing Avatrombopag maleate, Platelet transfusion and Medicine in people with Thrombocytopenia; Drugs and Chronic Liver Disease, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
In this study, investigators aimed to evaluate the efficacy of Avatrombopag in thrombocytopenic patients with chronic liver disease undergoing an elective invasive procedure through a prospective, non-randomized controlled, multicenter clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia; Drugs, Chronic Liver Disease
- What is being tested?
- Avatrombopag maleate, Platelet transfusion and Medicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 476 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2021to 31 Jul 2023
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both men and women are at least 18 years old at the time of signing the informed consent;
- Baseline platelet count<50×10^9/L;
- Patients with chronic liver disease undergo elective invasive procedures with high bleeding risk. The invasive procedures include liver/kidney biopsy or ablation, biliary drainage/stent implantation, cholecystostomy, transjugular intrahepatic portal venous shunt, nephrostomy and catheterization, chemotherapy embolization, abdominal/pelvic/retroperitoneal/mediastinal biopsy or ablation, endoscopic polypectomy, endoscopic stricture dilation or mucosal resection, balloon-assisted enteroscopy, percutaneous endoscopic gastrostomy, endoscopic retrograde cholangiopancreatography with sphincterotomy (ERCP + EST), endoscopic ultrasound with fine-needle aspiration (EUS-FNA), cyst gastrostomy, dental extraction, angiography or interventional venography and therapeutic coronary angiography such as PCI), and intraarticular injection, etc.;
- Be able to understand the study and is willing to follow all study procedures, and voluntarily sign informed consent before screening;
- According to the opinions of the researchers, it can meet the requirements of this study.
Who cannot join
- Subjects with a history of arterial or venous thrombosis within six months before baseline;
- Subjects with a known history of the hereditary prethrombotic syndrome include thrombin factor V Leiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency;
- Subjects could not suspend anticoagulants or antiplatelet therapy within one week preoperatively, such as heparin (within 24 hours before the procedure for Low molecular weight heparin), warfarin, rivaroxaban, dipyridamole, non-steroidal anti-inflammatory drugs, aspirin, verapamil, ticlopidine, clopidogrel, glycoprotein IIb/IIIa antagonists, and erythropoietin, etc.;
- Subjects could not suspend Chinese patent medicines within three days before the procedure to promote blood circulation and remove blood stasis, such as pseudo-ginseng, red-rooted salvia, etc.;
- Subjects received thrombopoietin receptor agonists within two weeks before enrolment, such as rhuTPO, Romiplostim, Eltrombopag, Avatrombopag, or Lusutrombopag, etc. Subjects received rhIL-11 within two weeks before enrolment. Moreover, subjects received platelet transfusion within one week before enrolment;
- Subjects with thrombocytopenia caused by primary blood diseases (immune thrombocytopenia, myelodysplastic syndrome, etc.) or drugs (such as chemotherapy drugs, targeted therapy drugs, immune checkpoint inhibitors, etc.). Exceptions: Subjects are allowed to receive targeted drugs that do not cause thrombocytopenia, provided that these targeted therapy drugs are discontinued for a while to reduce the risk of bleeding, as follows: Bevacizumab for four weeks (6 weeks for patients with coagulation abnormality), lumvaritinib, sorafenib, pazopanib, axitinib, cabozantinib, anlotinib, apatinib, nidanib, and sunitinib for one week, and fuquanitinib for two weeks, etc.;
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- Subjects scheduled for splenic embolization (excluding those with persistent low platelet counts after splenic embolization or splenectomy);
- Concomitant medical histories (e.g., gastrointestinal bleeding within three months; high risk of thrombosis, e.g., portal vein blood flow velocity < 10cm/s) may prevent subjects from completing the study safely;
- Subjects are allergic to avatrombopag or any of its excipients;
- A woman who is pregnant or who intends to become pregnant;
- Subjects participate in another clinical study using any exploratory drug or device within 30 days before their baseline visit; Participation in observational studies is permitted;
- The investigator considers that any accompanying medical history of the subject may affect the subject's ability to complete the study safely.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Ping Liang, Doctor
About this study
Official title: Efficacy of Avatrombopag in Thrombocytopenic Patients With Chronic Liver Disease Undergoing an Elective Procedure: A Prospective Non-randomized Controlled Trial
In this study, investigators aimed to evaluate the efficacy of Avatrombopag in thrombocytopenic patients with chronic liver disease undergoing an elective invasive procedure through a prospective, non-randomized controlled, multicenter clinical trial. The patients were non-randomly assigned to the Avatrombopag group (119 patients) and the conventional treatment group (357 patients). The primary endpoint was the proportion of patients not requiring prophylactic platelet transfusion or rescue therapy due to bleeding from grouping up to 10 days post-procedure. Second endpoints included the proportion of patients achieving a platelet count of ≥50x10^9/L and the mean change in platelet count from baseline at the time before the procedure, the proportion of patients requiring platelet transfusion and the mean platelet transfusion units per capita, the incidence of bleeding events (WHO≥2 and requiring rescue therapy), the imaging evaluations of bleeding events, the incidence of adverse events, the changes in life quality between two groups before and after treatment, and the pharmacoeconomic index of two groups.
Note: According to the results of interim statistical analysis (200-300 cases), it is up to the sponsor to decide whether to terminate the study in advance or increase the number of included cases at a later stage.
Read the detailed description
Thrombocytopenia is a common complication of chronic liver disease (CLD), which severity increases with the aggravation of CLD. TPO, the primary physiological regulator of platelet production, is mainly produced by the liver. With the progressive liver injury in patients with CLD, TPO production decreases, resulting in the reduction of platelet production and thrombocytopenia, which cause the significantly increased risk of bleeding during the invasive procedure in these patients and pose a severe challenge to clinical management.
Platelet transfusion is a standard clinical treatment for CLD-related thrombocytopenia. Whether prophylactic platelet transfusion is needed before elective invasive procedure depends on the level of platelet count and the judgment of medical staff on the risk of bleeding in those procedures. Clinically, without effective preventive treatment in severe thrombocytopenia (PLT< 50×10^9/L), the risk of bleeding in related procedures is high, the hospitalization is prolonged after bleeding, and other post-procedure complications may occur. However, repeated prophylactic platelet transfusion may lead to ineffective platelet transfusion.
ADAPT-1 and ADAPT-2 were identical design randomized, double-blinded, placebo-controlled, international multicenter phase III clinical trials. They confirmed that 1. Avatrombopag could significantly increase the platelet count in patients with chronic liver disease with severe thrombocytopenia (PLT<50×10^9/L), thus reducing the proportion of platelet transfusion or rescue due to bleeding in adult patients with chronic liver disease-associated thrombocytopenia undergoing elective invasive procedures; 2. In terms of safety, the incidence of adverse events in the Avatrombopag group was comparable to that in the placebo group. At present, Avatrombopag has been successively approved in Europe, the United States, and China for adult patients with chronic liver disease-associated thrombocytopenia undergoing elective invasive procedures.
Avatrombopag is effective and safe in raising platelet count in patients with chronic liver disease. In addition, it has the characteristics of no risk of neutralizing antibody generation from small molecules and convenient oral administration.
The purpose of this study was to observe the clinical benefit of Avatrombopag to raise platelet count in adult patients with chronic liver disease-associated thrombocytopenia who received elective high-risk invasive procedures and to validate the efficacy and safety of Avatrombopag further in Chinese population with different spectrum of etiology in chronic liver disease.
Note: According to the results of interim statistical analysis (200-300 cases), it is up to the sponsor to decide whether to terminate the study in advance or increase the number of included cases at a later stage.
- Conditions
- Thrombocytopenia; Drugs, Chronic Liver Disease
- Being tested
- Avatrombopag maleate, Platelet transfusion, Medicine
- Keywords
- Thrombocytopenia, Chronic Liver Disease, Avatrombopag, Invasive procedure
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avatrombopag maleateDrug
Also called Doptelet
- Mean baseline platelet count 40 to less than 50 × 10^9/L: 40mg Avatrombopag QD × 5 days from 10-13 days pre-procedure
- Mean baseline platelet count less than 40 × 10^9/L: 60mg Avatrombopag QD × 5 days from 10-13 days pre-procedure
Platelet transfusionBiological
Mean baseline platelet count less than 50 × 10^9/L pre-procedure: platelet transfusion if needed
MedicineDrug
Also called Other drugs
Mean baseline platelet count less than 50 × 10^9/L pre-procedure: rhuTPO, rhIL-11, Romiplostim, Eltrombopag, or Lusutrombopag, etc.
| Study group | Role | What they receive |
|---|---|---|
| Avatrombopag | Experimental | Oral administration of Avatrombopag Maleate Tablets to the thrombocytopenic patients with chronic liver disease undergoing an elective procedure whose mean baseline platelet count is less than 50 × 10^9/L. RhuTPO, rhIL-11, Romiplostim, Eltrombopag, or Lusutrombopag, etc., are prohibited during the trial. Receives: Drug: Avatrombopag maleate |
| Conventional treatment | Experimental | Conventional treatment (platelet transfusion if needed or rhuTPO, rhIL-11, Romiplostim, Eltrombopag, or Lusutrombopag, etc.) to the thrombocytopenic patients with chronic liver disease undergoing an elective procedure whoes mean baseline platelet count is less than 50 × 10^9/L. Receives: Biological: Platelet transfusion; Drug: Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients not requiring prophylactic platelet transfusion
The proportion of patients not requiring prophylactic platelet transfusion
Measured: From grouping up to 10 days post-procedure
The proportion of patients not requiring rescue therapy due to bleeding
The proportion of patients not requiring rescue therapy due to bleeding
Measured: From grouping up to 10 days post-procedure
Secondary outcomes (9)
The proportion of patients achieving a platelet count of ≥50x10^9/L
The proportion of patients achieving a platelet count of ≥50x10^9/L
Measured: The time before the procedure in the procedure day
The mean change in platelet count from baseline
The mean change in platelet count from baseline
Measured: The time before the procedure in the procedure day
The proportion of patients requiring platelet transfusion
The proportion of patients requiring platelet transfusion
Measured: From grouping up to 10 days post-procedure
The mean platelet transfusion units per capital
The mean platelet transfusion units per capital
Measured: From grouping up to 10 days post-procedure
The incidence of bleeding events
The recorded bleeding events included WHO≥2 and requiring rescue therapy
Measured: From grouping up to 10 days post-procedure
The imaging evaluations of bleeding events
The imaging evaluations of bleeding events
Measured: From grouping up to 10 days post-procedure
The Incidence of adverse events
The Incidence of adverse events
Measured: From grouping up to 10 days post-procedure
The changes in life quality between two groups assessed by EuroQol Five Dimensions Questionnaire
The changes in life quality between two groups assessed by EuroQol Five Dimensions Questionnaire (EQ-5D) include mobility, self-care, usual activities, pain/discomfort, anxiety/depression. All five dimensions are described by three problem levels corresponding to patient response choices. The EQ-5D total score from the five dimensions ranges from 0 (worst health state) to 1 (perfect health state), and 1 reflects the best outcome.
Measured: From grouping up to 10 days post-procedure
The pharmacoeconomic indexes of two groups
The pharmacoeconomic indexes include the cost of examination, the cost of medicine in platelet-raising, the cost of preventive measures for bleeding, the cost related to bleeding events, the cost of adverse events and the cost of health insurance, which are recorded in Chinese Yuan.
Measured: From grouping up to 10 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start6 Jun 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombocytopenia; DrugsStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 476 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
- Investigators
- Ping Liang, Doctor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915287
- Sponsor's protocol ID
- S2021-240-02
- Status last verified
- Nov 2022
- First submitted
- 23 May 2021
- Last updated
- 15 Nov 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Avatrombopag in Thrombocytopenic Patients With Chronic Liver Disease Undergoing an Elective Procedure: A Prospective Non-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04915287
- Acronym / sponsor ID
- S2021-240-02
- Conditions
- Thrombocytopenia; Drugs, Chronic Liver Disease
- Keywords
- Thrombocytopenia, Chronic Liver Disease, Avatrombopag, Invasive procedure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 476 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 7 Jun 2021 (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.
In this study, investigators aimed to evaluate the efficacy of Avatrombopag in thrombocytopenic patients with chronic liver disease undergoing an elective invasive procedure through a prospective, non-randomized controlled, multicenter clinical trial. The patients were non-randomly assigned to the Avatrombopag group (119 patients) and the conventional treatment group (357 patients). The primary endpoint was the proportion of patients not requiring prophylactic platelet transfusion or rescue therapy due to bleeding from grouping up to 10 days post-procedure. Second endpoints included the proportion of patients achieving a platelet count of ≥50x10^9/L and the mean change in platelet count from baseline at the time before the procedure, the proportion of patients requiring platelet transfusion and the mean platelet transfusion units per capita, the incidence of bleeding events (WHO≥2 and requiring rescue therapy), the imaging evaluations of bleeding events, the incidence of adverse events, the changes in life quality between two groups before and after treatment, and the pharmacoeconomic index of two groups.
Note: According to the results of interim statistical analysis (200-300 cases), it is up to the sponsor to decide whether to terminate the study in advance or increase the number of included cases at a later stage.
Detailed description
Thrombocytopenia is a common complication of chronic liver disease (CLD), which severity increases with the aggravation of CLD. TPO, the primary physiological regulator of platelet production, is mainly produced by the liver. With the progressive liver injury in patients with CLD, TPO production decreases, resulting in the reduction of platelet production and thrombocytopenia, which cause the significantly increased risk of bleeding during the invasive procedure in these patients and pose a severe challenge to clinical management.
Platelet transfusion is a standard clinical treatment for CLD-related thrombocytopenia. Whether prophylactic platelet transfusion is needed before elective invasive procedure depends on the level of platelet count and the judgment of medical staff on the risk of bleeding in those procedures. Clinically, without effective preventive treatment in severe thrombocytopenia (PLT< 50×10^9/L), the risk of bleeding in related procedures is high, the hospitalization is prolonged after bleeding, and other post-procedure complications may occur. However, repeated prophylactic platelet transfusion may lead to ineffective platelet transfusion.
ADAPT-1 and ADAPT-2 were identical design randomized, double-blinded, placebo-controlled, international multicenter phase III clinical trials. They confirmed that 1. Avatrombopag could significantly increase the platelet count in patients with chronic liver disease with severe thrombocytopenia (PLT<50×10^9/L), thus reducing the proportion of platelet transfusion or rescue due to bleeding in adult patients with chronic liver disease-associated thrombocytopenia undergoing elective invasive procedures; 2. In terms of safety, the incidence of adverse events in the Avatrombopag group was comparable to that in the placebo group. At present, Avatrombopag has been successively approved in Europe, the United States, and China for adult patients with chronic liver disease-associated thrombocytopenia undergoing elective invasive procedures.
Avatrombopag is effective and safe in raising platelet count in patients with chronic liver disease. In addition, it has the characteristics of no risk of neutralizing antibody generation from small molecules and convenient oral administration.
The purpose of this study was to observe the clinical benefit of Avatrombopag to raise platelet count in adult patients with chronic liver disease-associated thrombocytopenia who received elective high-risk invasive procedures and to validate the efficacy and safety of Avatrombopag further in Chinese population with different spectrum of etiology in chronic liver disease.
Note: According to the results of interim statistical analysis (200-300 cases), it is up to the sponsor to decide whether to terminate the study in advance or increase the number of included cases at a later stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avatrombopag | Experimental | Drug: Avatrombopag maleateOral administration of Avatrombopag Maleate Tablets to the thrombocytopenic patients with chronic liver disease undergoing an elective procedure whose mean baseline platelet count is less than 50 × 10^9/L. RhuTPO, rhIL-11, Romiplostim, Eltrombopag, or Lusutrombopag, etc., are prohibited during the trial. |
| Conventional treatment | Experimental | Biological: Platelet transfusion, Drug: MedicineConventional treatment (platelet transfusion if needed or rhuTPO, rhIL-11, Romiplostim, Eltrombopag, or Lusutrombopag, etc.) to the thrombocytopenic patients with chronic liver disease undergoing an elective procedure whoes mean baseline platelet count is less than 50 × 10^9/L. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both men and women are at least 18 years old at the time of signing the informed consent;
- Baseline platelet count<50×10^9/L;
- Patients with chronic liver disease undergo elective invasive procedures with high bleeding risk. The invasive procedures include liver/kidney biopsy or ablation, biliary drainage/stent implantation, cholecystostomy, transjugular intrahepatic portal venous shunt, nephrostomy and catheterization, chemotherapy embolization, abdominal/pelvic/retroperitoneal/mediastinal biopsy or ablation, endoscopic polypectomy, endoscopic stricture dilation or mucosal resection, balloon-assisted enteroscopy, percutaneous endoscopic gastrostomy, endoscopic retrograde cholangiopancreatography with sphincterotomy (ERCP + EST), endoscopic ultrasound with fine-needle aspiration (EUS-FNA), cyst gastrostomy, dental extraction, angiography or interventional venography and therapeutic coronary angiography such as PCI), and intraarticular injection, etc.;
- Be able to understand the study and is willing to follow all study procedures, and voluntarily sign informed consent before screening;
- According to the opinions of the researchers, it can meet the requirements of this study.
Key exclusion criteria (12 listed)
- Subjects with a history of arterial or venous thrombosis within six months before baseline;
- Subjects with a known history of the hereditary prethrombotic syndrome include thrombin factor V Leiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency;
- Subjects could not suspend anticoagulants or antiplatelet therapy within one week preoperatively, such as heparin (within 24 hours before the procedure for Low molecular weight heparin), warfarin, rivaroxaban, dipyridamole, non-steroidal anti-inflammatory drugs, aspirin, verapamil, ticlopidine, clopidogrel, glycoprotein IIb/IIIa antagonists, and erythropoietin, etc.;
- Subjects could not suspend Chinese patent medicines within three days before the procedure to promote blood circulation and remove blood stasis, such as pseudo-ginseng, red-rooted salvia, etc.;
- Subjects received thrombopoietin receptor agonists within two weeks before enrolment, such as rhuTPO, Romiplostim, Eltrombopag, Avatrombopag, or Lusutrombopag, etc. Subjects received rhIL-11 within two weeks before enrolment. Moreover, subjects received platelet transfusion within one week before enrolment;
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 |
|---|---|---|
| Avatrombopag maleateAlso: Doptelet1. Mean baseline platelet count 40 to less than 50 × 10^9/L: 40mg Avatrombopag QD × 5 days from 10-13 days pre-procedure 2. Mean baseline platelet count less than 40 × 10^9/L: 60mg Avatrombopag QD × 5 days from 10-13 days pre-procedure | Drug | Avatrombopag |
| Platelet transfusionMean baseline platelet count less than 50 × 10^9/L pre-procedure: platelet transfusion if needed | Biological | Conventional treatment |
| MedicineAlso: Other drugsMean baseline platelet count less than 50 × 10^9/L pre-procedure: rhuTPO, rhIL-11, Romiplostim, Eltrombopag, or Lusutrombopag, etc. | Drug | Conventional treatment |
Primary outcome
The proportion of patients not requiring prophylactic platelet transfusion
Time frame: From grouping up to 10 days post-procedure
The proportion of patients not requiring prophylactic platelet transfusion
The proportion of patients not requiring rescue therapy due to bleeding
Time frame: From grouping up to 10 days post-procedure
The proportion of patients not requiring rescue therapy due to bleeding
9 secondary outcomes
The proportion of patients achieving a platelet count of ≥50x10^9/L
Time frame: The time before the procedure in the procedure day
The mean change in platelet count from baseline
Time frame: The time before the procedure in the procedure day
The proportion of patients requiring platelet transfusion
Time frame: From grouping up to 10 days post-procedure
The mean platelet transfusion units per capital
Time frame: From grouping up to 10 days post-procedure
The incidence of bleeding events
Time frame: From grouping up to 10 days post-procedure
The imaging evaluations of bleeding events
Time frame: From grouping up to 10 days post-procedure
The Incidence of adverse events
Time frame: From grouping up to 10 days post-procedure
The changes in life quality between two groups assessed by EuroQol Five Dimensions Questionnaire
Time frame: From grouping up to 10 days post-procedure
The pharmacoeconomic indexes of two groups
Time frame: From grouping up to 10 days post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 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.
Ping Liang, Doctor principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Avatrombopag maleate, Platelet transfusion and Medicine in people with Thrombocytopenia; Drugs and Chronic Liver Disease, run by Chinese PLA General 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 12 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 15 Nov 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shuilian Tan, Master (15910606696, 15910606696@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients not requiring prophylactic platelet transfusion (time frame: From grouping up to 10 days post-procedure). The study lists 2 primary outcomes in all. 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 15 Nov 2022.