BleedingNCT02677818
The Relationship Between Clotting Factor VIII and Bleeding Adverse Reactions in Patients Under the Therapies of Thrombolysis, Anticoagulation and Anti-platelet
An observational study of Bleeding and Ischemic Stroke, run by Zhujiang Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether Plasma Factor VIII Levels are related to the treatment of bleeding in ischemic stroke（IS）. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Bleeding, Ischemic Stroke
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Aug 2021
- Phase
- Observational
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The stroke patient using Anti-thrombotic drugs diagnosed by Zhujiang Hospital.
Who may be able to join
- Guidelines prepared by the diagnostic criteria(according to the diagnostic criteria of the Fourth National Stroke Conference prepared,have been more than one times skull CT and/or MRI)was confirmed for ischemic stroke,and requires the use of antithrombotic therapy(including thrombolysis, anticoagulation, antiplatelet) patients
- Willing and able to comply with the study protocol and visits planned
Who cannot join
- At the same time the presence of other active malignancy.
- There is known brain metastases or leptomeningeal metastases
- Systemic active infection ( ie infection leads to body temperature ≥38 ℃)
- The last 4 weeks there is a need drainage ascites, pleural effusion or pericardial fluid .
- Clinically significant obstruction , pulmonary fibrosis , kidney failure , liver failure and other diseases.
- Uncontrolled diabetes.
Show all 13Show fewer
- Severe / unstable angina, New York Heart Association (NYHA) class III or IV symptoms of congestive heart failure
- there is other reason (not the antithrombotic drugs) caused by bleeding.
- The presence of an autoimmune disease or a history of organ transplant patients require immunosuppressive therapy
- Psychiatric presence may increase the risks associated with study participation or study drug , or may interfere with the interpretation of study results
- Pregnant and lactating women
- Bleeding disorders may exist on admission
- The researchers added that the study is not appropriate to the circumstances
Trial locations and contacts
1 site in 1 country.
China1 site
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
About this study
The purpose of this study is to determine whether Plasma Factor VIII Levels are related to the treatment of bleeding in ischemic stroke（IS）.
Read the detailed description
Clear cerebral infarction patients during hospitalization, treatment process, discharge and hemorrhage occurs, the stages F VIII level change and its correlation with bleeding adverse reactions. Analysis F VIII whether belong to hemorrhage occurs independent risk factors of adverse drug reactions,as well as the feasibility of predicting bleeding occurred adverse reaction index.
- Conditions
- Bleeding, Ischemic Stroke
- Keywords
- Plasma Factor VIII Levels, Ischemic stroke, Antithrombotic therapy, Bleeding
- Medical subject headings
- Hemorrhage, 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 |
|---|---|---|
| experimental group | The risk of bleeding adverse reactions when FVIII below the normal level. | |
| control group | The risk of bleeding adverse reactions when FVIII in normal level. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The levels of FVIII are measured by enzyme-linked immuno sorbent assay.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2018 (estimated)
- Study completionAug 2021 (estimated)
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- More trials run by Zhujiang 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Province, Department of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Yong Wang, Doctor, Study director, clinical drug trial institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677818
- Sponsor's protocol ID
- 2014-YXB-001
- Status last verified
- Jul 2021
- First submitted
- 5 Feb 2016
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Clotting Factor VIII and Bleeding Adverse Reactions in Patients Under the Therapies of Thrombolysis, Anticoagulation and Anti-platelet
- ClinicalTrials.gov ID
- NCT02677818
- Acronym / sponsor ID
- 2014-YXB-001
- Conditions
- Bleeding, Ischemic Stroke
- Keywords
- Plasma Factor VIII Levels, Ischemic stroke, Antithrombotic therapy, Bleeding
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Guangdong Province, Department of Science and Technology
- Study start
- May 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 9 Feb 2016 (estimated)
- 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 purpose of this study is to determine whether Plasma Factor VIII Levels are related to the treatment of bleeding in ischemic stroke（IS）.
Detailed description
Clear cerebral infarction patients during hospitalization, treatment process, discharge and hemorrhage occurs, the stages F VIII level change and its correlation with bleeding adverse reactions. Analysis F VIII whether belong to hemorrhage occurs independent risk factors of adverse drug reactions,as well as the feasibility of predicting bleeding occurred adverse reaction index.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | –The risk of bleeding adverse reactions when FVIII below the normal level. |
| control group | – | –The risk of bleeding adverse reactions when FVIII in normal level. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The stroke patient using Anti-thrombotic drugs diagnosed by Zhujiang Hospital.
Key inclusion criteria (2 listed)
- Guidelines prepared by the diagnostic criteria(according to the diagnostic criteria of the Fourth National Stroke Conference prepared,have been more than one times skull CT and/or MRI)was confirmed for ischemic stroke,and requires the use of antithrombotic therapy(including thrombolysis, anticoagulation, antiplatelet) patients
- Willing and able to comply with the study protocol and visits planned
Key exclusion criteria (13 listed)
- At the same time the presence of other active malignancy.
- There is known brain metastases or leptomeningeal metastases
- Systemic active infection ( ie infection leads to body temperature ≥38 ℃)
- The last 4 weeks there is a need drainage ascites, pleural effusion or pericardial fluid .
- Clinically significant obstruction , pulmonary fibrosis , kidney failure , liver failure and other diseases.
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
The levels of FVIII are measured by enzyme-linked immuno sorbent assay.
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: Yes
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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.
Yong Wang, Doctor study director
clinical drug trial institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding and Ischemic Stroke, run by Zhujiang 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 2 inclusion and 13 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: withdrawn, as of the sponsor's last update on 4 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The levels of FVIII are measured by enzyme-linked immuno sorbent assay. (time frame: one year). 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 4 Apr 2022.