Intracranial AneurysmEODHS-IANCT05749393
Effect of Different Heparinization Schemes on Prognosis of Intracranial Aneurysm
A study testing Heparin sodium in people with Intracranial Aneurysm, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to compare intracranial aneurysm patients. The main question it aims to answer are: Which heparinization regimen is most beneficial to patients during surgery for intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Heparin sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2023to 1 Apr 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than 18 years old, less than 75 years old
- Patients with unruptured intracranial aneurysm were confirmed by DSA.
- Coagulation function should be normal in the enrolled patients.
Who cannot join
- Dissection aneurysm, blister aneurysm, moyamoya disease or arteriovenous malformation.
- Previous use of antithrombotic drugs (including anticoagulant or antiplatelet aggregation drugs).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Province Hospital
Nanjing
Hua Lu, +8618761671021, luhua@njmu.edu.cn
About this study
Official title: Effect of Heparinization on Intracranial Aneurysm
The goal of this clinical trial is to compare intracranial aneurysm patients. The main question it aims to answer are: Which heparinization regimen is most beneficial to patients during surgery for intracranial aneurysms. Participants will be randomized to different intraoperative heparinization regimens: (i) 50 U/kg intravenous (IV) at 1-h intervals reduced by half to a minimum of 1000 u/h; (ii) 70 U/kg IV at 1-h intervals reduced by half to a minimum of 1000 u/h. MRI will be performed within 72 h after surgery, and the DWI sequence of MRI will be analyzed. If there is a comparison group: Researchers will compare different intraoperative heparinization protocol groups to see which dose of intraoperative heparin has the best prognosis for use.
- Conditions
- Intracranial Aneurysm
- Being tested
- Heparin sodium
- Keywords
- Intracranial Aneurysm
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin sodiumDrug
Intravenous heparin was administered during intracranial aneurysm embolization with a guide catheter and discontinued at the end of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Experimental | The initial dose was 50U/kg intravenous injection, and the dosage was halved by intravenous injection every 1 hour to the minimum 1000u/h. The medication will be discontinued at the end of the procedure. Receives: Drug: Heparin sodium |
| High-dose group | Experimental | The initial dose was 70U/kg intravenous injection, and the dosage was halved by intravenous injection every 1 hour to the minimum 1000u/h. The medication will be discontinued at the end of the procedure. Receives: Drug: Heparin sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of the ischemic focus
Cranial MRI will be performed on postoperative patients within 24 hours. The presence of high signal on diffusion weighted imaging sequences indicated the occurrence of cerebral infarction.
Measured: This will be evaluated within 24 hours after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start30 Apr 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Hua, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Hua Lu, Doctor, Principal investigator, First Affiliated Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749393
- Sponsor's protocol ID
- EODHS-IA
- Acronym
- EODHS-IA
- Status last verified
- Dec 2023
- First submitted
- 17 Feb 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be available to other researchers under the approval of the ethical committee.
Publications
Zhang L, Zhou X, Liu Y, Ding C, Wang Y, Yang H. The Utility of Diffusion-Weighted MRI Lesions to Compare the Effects of Different Heparinization Schemes in Intracranial Aneurysms Treated by Endovascular Intervention. Front Neurol. 2020 Dec 10;11:609384. doi: 10.3389/fneur.2020.609384. eCollection 2020.
PubMed 33424758Narata AP, Amelot A, Bibi R, Herbreteau D, Angoulvant D, Gruel Y, Janot K. Dual Antiplatelet Therapy Combining Aspirin and Ticagrelor for Intracranial Stenting Procedures: A Retrospective Single Center Study of 154 Consecutive Patients With Unruptured Aneurysms. Neurosurgery. 2019 Jan 1;84(1):77-83. doi: 10.1093/neuros/nyy002.
PubMed 29490066
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Heparinization on Intracranial Aneurysm
- ClinicalTrials.gov ID
- NCT05749393
- Acronym / sponsor ID
- EODHS-IA / EODHS-IA
- Conditions
- Intracranial Aneurysm
- Keywords
- Intracranial Aneurysm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 1 Mar 2023 (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 goal of this clinical trial is to compare intracranial aneurysm patients. The main question it aims to answer are: Which heparinization regimen is most beneficial to patients during surgery for intracranial aneurysms. Participants will be randomized to different intraoperative heparinization regimens: (i) 50 U/kg intravenous (IV) at 1-h intervals reduced by half to a minimum of 1000 u/h; (ii) 70 U/kg IV at 1-h intervals reduced by half to a minimum of 1000 u/h. MRI will be performed within 72 h after surgery, and the DWI sequence of MRI will be analyzed. If there is a comparison group: Researchers will compare different intraoperative heparinization protocol groups to see which dose of intraoperative heparin has the best prognosis for use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose group | Experimental | Drug: Heparin sodiumThe initial dose was 50U/kg intravenous injection, and the dosage was halved by intravenous injection every 1 hour to the minimum 1000u/h. The medication will be discontinued at the end of the procedure. |
| High-dose group | Experimental | Drug: Heparin sodiumThe initial dose was 70U/kg intravenous injection, and the dosage was halved by intravenous injection every 1 hour to the minimum 1000u/h. The medication will be discontinued at the end of the procedure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Greater than 18 years old, less than 75 years old
- Patients with unruptured intracranial aneurysm were confirmed by DSA.
- Coagulation function should be normal in the enrolled patients.
Key exclusion criteria (2 listed)
- Dissection aneurysm, blister aneurysm, moyamoya disease or arteriovenous malformation.
- Previous use of antithrombotic drugs (including anticoagulant or antiplatelet aggregation drugs).
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 |
|---|---|---|
| Heparin sodiumIntravenous heparin was administered during intracranial aneurysm embolization with a guide catheter and discontinued at the end of the procedure. | Drug | High-dose group, Low-dose group |
Primary outcome
Size of the ischemic focus
Time frame: This will be evaluated within 24 hours after the procedure.
Cranial MRI will be performed on postoperative patients within 24 hours. The presence of high signal on diffusion weighted imaging sequences indicated the occurrence of cerebral infarction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Background: PubMed 33424758Zhang L, Zhou X, Liu Y, Ding C, Wang Y, Yang H. The Utility of Diffusion-Weighted MRI Lesions to Compare the Effects of Different Heparinization Schemes in Intracranial Aneurysms Treated by Endovascular Intervention. Front Neurol. 2020 Dec 10;11:609384. doi: 10.3389/fneur.2020.609384. eCollection 2020.
- Background: PubMed 29490066Narata AP, Amelot A, Bibi R, Herbreteau D, Angoulvant D, Gruel Y, Janot K. Dual Antiplatelet Therapy Combining Aspirin and Ticagrelor for Intracranial Stenting Procedures: A Retrospective Single Center Study of 154 Consecutive Patients With Unruptured Aneurysms. Neurosurgery. 2019 Jan 1;84(1):77-83. doi: 10.1093/neuros/nyy002.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be available to other researchers under the approval of the ethical committee.
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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.
Hua Lu, Doctor principal investigator
First Affiliated Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heparin sodium in people with Intracranial Aneurysm, run by The First Affiliated Hospital with Nanjing Medical University 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 3 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: status not confirmed, as of the sponsor's last update on 22 Dec 2023. 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 Hua Lu, Doctor (18761671021, luhua@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of the ischemic focus (time frame: This will be evaluated within 24 hours after the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05749393, which also lists 2 linked publications.
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 Dec 2023.