Cerebral AngiographyPhase 4SELECTNCT06365398
Safety and Efficacy of Low-dose hEparinization in Cerebral Angiography sTudy
A Phase 4 study testing Heparin, Heparin Sodium Injection and No heparinization in people with Cerebral Angiography and Heparinization, run by Xuanwu Hospital, Beijing at 2 sites in China.
Trial summary
Purpose: Systemic heparinization is a widely used technique on digital subtraction angiography (DSA). Heparin, however, is associated with a variety of complications, including hemorrhage, thrombocytopenia, and hematomas. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cerebral Angiography, Heparinization
- What is being tested?
- Heparin, Heparin Sodium Injection and No heparinization
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2018to 1 Jan 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-65 years;
- suspected cerebrovascular disease, including vascular lesions of the carotid, middle cerebral, anterior cerebral, vertebral, basilar, and posterior cerebral arteries;
- Activity of daily living (ADL) score between 85~100;
- normal coagulation function and no prior anticoagulant therapy before DSA;
- fully informed consent to participate in the study.
Who cannot join
- iodine allergy;
- hepatic and/or renal insufficiency;
- severe hypertension with poor blood pressure control;
- hemorrhagic diseases;
- hyperlipidemia;
- poor glycemic control in diabetes;
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- pregnancy;
- atrial fibrillation;
- undergoing interventional treatment simultaneously.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality
Xuanwu Hospital, Capital Medical University.
Beijing, 100053
About this study
Official title: Safety and Efficacy of Low-dose Heparinization in Cerebral Angiography: a Randomized Controlled Study
Purpose: Systemic heparinization is a widely used technique on digital subtraction angiography (DSA). Heparin, however, is associated with a variety of complications, including hemorrhage, thrombocytopenia, and hematomas. This study aimed to investigate the safety and efficacy of micro-dose systemic heparinization or no heparinization on cerebral angiography for cerebrovascular diseases.
Methods: A prospective, single-blind, randomized controlled study on patients who experienced transient ischemic attacks (TIAs) or acute ischemic strokes and underwent DSA is performed. Participants are randomized into three groups: regular-dose systemic heparinization, micro-dose systemic heparinization, and no heparinization. Information on patient demographics, laboratory tests, perioperative complications, and back pain scores is collected. Safety endpoints are defined as cerebral ischemic events and local complications of puncture site. Efficacy endpoints were defined as the recovery of the patients.
- Conditions
- Cerebral Angiography, Heparinization
- Being tested
- Heparin, Heparin Sodium Injection, No heparinization
- Keywords
- cerebral angiography, heparin, Nursing, Ischemic Stroke, Safety, Efficacy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
Also called Regular-dose heparinization
As soon as the sheath was inserted, three different doses of heparin were administered according to the patients group assignment. In the conventional systemic heparinization (Regular-dose) group (The drug is Heparin Sodium Injection 2ml:12500 Units per bottle), systemic heparin was administered by intravenous injection at a dose of 83 Units/Kg. Patients in both the regular dose (83 units/kg) and low dose (42 units/kg) groups were given heparin intravenously once before the procedure of cerebral angiography, and no further heparin infusion was given during the angiography procedure. If the duration of the imaging procedure exceeded 1 hour, an additional 1/2 amount of the first dose of heparin was given.
Heparin Sodium InjectionDrug
Also called Micro-dose heparinization
In the micro-dose systemic heparinization (Micro-dose) group (the drug is Heparin Sodium Injection 2ml:12500 Units per bottle), systemic heparin was administered by intravenous injection at a dose of 42 Units/Kg. Patients in both the regular dose (83 units/kg) and low dose (42 units/kg) groups were given heparin intravenously once before the procedure of cerebral angiography, and no further heparin infusion was given during the angiography procedure. If the duration of the imaging procedure exceeded 1 hour, an additional 1/2 amount of the first dose of heparin was given.
No heparinizationOther
No additional heparin was administered via the sheath or arterial route in the no heparinization group.
| Study group | Role | What they receive |
|---|---|---|
| Regular-dose group | Active comparator | 3000~5000 Units of normal heparin was injected via the sheath tube in the systemic heparinization (Regular-dose) group. Half a dose of normal heparin is added after the imaging session has lasted more than half an hour. Receives: Drug: Heparin |
| Micro-dose group | Experimental | Micro-dose group is performed with two bags of 500 milliliter(ml) saline with 2500 Units of heparin were used to make a 5000 Units per liter heparin saline, which was used to infuse anticoagulation. Receives: Drug: Heparin Sodium Injection |
| heparinization group | Experimental | No heparinization is performed with no additional heparin is administered by a sheath or arterial route in the third group. Receives: Other: No heparinization |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative cerebral infarction
The safety endpoints of the study were postoperative cerebral infarction on imaging, and local complications such as bleeding at the puncture site, subcutaneous hematoma, and pseudoaneurysm diagnosed by computed tomography angiography (CTA). All patients underwent magnetic resonance imaging within 48 hours after cerebral angiography to check for new ischemic infarction. Postoperative ischemia was characterized as the abrupt appearance of novel neurological deficits, including hemiplegia, hemianopia, aphasia, dysphagia, sensory impairment, or confusion, persisting for more than 24 hours, accompanied with the presence of newly detected cerebral infarction using diffusion-weighted magnetic resonance imaging or computed tomography.
Measured: Perioperative period
Secondary outcomes (4)
Numerical Rating Scale (NRS) for back pain
Numerical Rating Scale (NRS) for back pain is assessed by investigators after intervention
Measured: 24 hours after intervention
the incidence of paralysis of surgical limb
the incidence of paralysis is assessed after intervention
Measured: 24 hours after intervention
the incidence of pain of surgical limb
the incidence of pain of surgical limb is assessed after intervention
Measured: 24 hours after intervention
the incidence of postoperative urethral catheterization
the incidence of postoperative urethral catheterization is assessed after intervention.
Measured: 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Jan 2018
- Primary completion1 Jun 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral AngiographyStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients enrolled are randomly divided into three groups according to the random number principle, which includes conventional systemic heparinization group, micro-dose systemic heparinization, and heparin-free angiography. It is carried out with a 1:1:1 ratio and variable block sizes.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365398
- Sponsor's protocol ID
- SELECT
- Other IDs
- XWHL-2018010
- Acronym
- SELECT
- Status last verified
- Mar 2018
- First submitted
- 26 Mar 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Z, Luo J, Qin Q, Tang H, Yao H, Wang T, Feng F, Li W, Sun M, Jiao L. Safety and efficacy of low dose or no heparinization in cerebral angiography: A randomized controlled study (SELECT trial). Brain Circ. 2024 Sep 13;11(4):301-308. doi: 10.4103/bc.bc_41_24. eCollection 2025 Oct-Dec.
PubMed 41531874
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Low-dose Heparinization in Cerebral Angiography: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06365398
- Acronym / sponsor ID
- SELECT / SELECT
- Conditions
- Cerebral Angiography, Heparinization
- Keywords
- cerebral angiography, heparin, Nursing, Ischemic Stroke, Safety, Efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 15 Apr 2024 (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.
Purpose: Systemic heparinization is a widely used technique on digital subtraction angiography (DSA). Heparin, however, is associated with a variety of complications, including hemorrhage, thrombocytopenia, and hematomas. This study aimed to investigate the safety and efficacy of micro-dose systemic heparinization or no heparinization on cerebral angiography for cerebrovascular diseases.
Methods: A prospective, single-blind, randomized controlled study on patients who experienced transient ischemic attacks (TIAs) or acute ischemic strokes and underwent DSA is performed. Participants are randomized into three groups: regular-dose systemic heparinization, micro-dose systemic heparinization, and no heparinization. Information on patient demographics, laboratory tests, perioperative complications, and back pain scores is collected. Safety endpoints are defined as cerebral ischemic events and local complications of puncture site. Efficacy endpoints were defined as the recovery of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- All patients enrolled are randomly divided into three groups according to the random number principle, which includes conventional systemic heparinization group, micro-dose systemic heparinization, and heparin-free angiography. It is carried out with a 1:1:1 ratio and variable block sizes.
| Arm | Type | Receives |
|---|---|---|
| Regular-dose group | Active comparator | Drug: Heparin3000~5000 Units of normal heparin was injected via the sheath tube in the systemic heparinization (Regular-dose) group. Half a dose of normal heparin is added after the imaging session has lasted more than half an hour. |
| Micro-dose group | Experimental | Drug: Heparin Sodium InjectionMicro-dose group is performed with two bags of 500 milliliter(ml) saline with 2500 Units of heparin were used to make a 5000 Units per liter heparin saline, which was used to infuse anticoagulation. |
| heparinization group | Experimental | Other: No heparinizationNo heparinization is performed with no additional heparin is administered by a sheath or arterial route in the third group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 18-65 years;
- suspected cerebrovascular disease, including vascular lesions of the carotid, middle cerebral, anterior cerebral, vertebral, basilar, and posterior cerebral arteries;
- Activity of daily living (ADL) score between 85~100;
- normal coagulation function and no prior anticoagulant therapy before DSA;
- fully informed consent to participate in the study.
Key exclusion criteria (9 listed)
- iodine allergy;
- hepatic and/or renal insufficiency;
- severe hypertension with poor blood pressure control;
- hemorrhagic diseases;
- hyperlipidemia;
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 |
|---|---|---|
| HeparinAlso: Regular-dose heparinizationAs soon as the sheath was inserted, three different doses of heparin were administered according to the patients group assignment. In the conventional systemic heparinization (Regular-dose) group (The drug is Heparin Sodium Injection 2ml:12500 Units per bottle), systemic heparin was administered by intravenous injection at a dose of 83 Units/Kg. Patients in both the regular dose (83 units/kg) and low dose (42 units/kg) groups were given heparin intravenously once before the procedure of cerebral angiography, and no further heparin infusion was given during the angiography procedure. If the duration of the imaging procedure exceeded 1 hour, an additional 1/2 amount of the first dose of heparin was given. | Drug | Regular-dose group |
| Heparin Sodium InjectionAlso: Micro-dose heparinizationIn the micro-dose systemic heparinization (Micro-dose) group (the drug is Heparin Sodium Injection 2ml:12500 Units per bottle), systemic heparin was administered by intravenous injection at a dose of 42 Units/Kg. Patients in both the regular dose (83 units/kg) and low dose (42 units/kg) groups were given heparin intravenously once before the procedure of cerebral angiography, and no further heparin infusion was given during the angiography procedure. If the duration of the imaging procedure exceeded 1 hour, an additional 1/2 amount of the first dose of heparin was given. | Drug | Micro-dose group |
| No heparinizationNo additional heparin was administered via the sheath or arterial route in the no heparinization group. | Other | heparinization group |
Primary outcome
postoperative cerebral infarction
Time frame: Perioperative period
The safety endpoints of the study were postoperative cerebral infarction on imaging, and local complications such as bleeding at the puncture site, subcutaneous hematoma, and pseudoaneurysm diagnosed by computed tomography angiography (CTA). All patients underwent magnetic resonance imaging within 48 hours after cerebral angiography to check for new ischemic infarction. Postoperative ischemia was characterized as the abrupt appearance of novel neurological deficits, including hemiplegia, hemianopia, aphasia, dysphagia, sensory impairment, or confusion, persisting for more than 24 hours, accompanied with the presence of newly detected cerebral infarction using diffusion-weighted magnetic resonance imaging or computed tomography.
4 secondary outcomes
Numerical Rating Scale (NRS) for back pain
Time frame: 24 hours after intervention
the incidence of paralysis of surgical limb
Time frame: 24 hours after intervention
the incidence of pain of surgical limb
Time frame: 24 hours after intervention
the incidence of postoperative urethral catheterization
Time frame: 24 hours after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Derived from this study: PubMed 41531874Wang Z, Luo J, Qin Q, Tang H, Yao H, Wang T, Feng F, Li W, Sun M, Jiao L. Safety and efficacy of low dose or no heparinization in cerebral angiography: A randomized controlled study (SELECT trial). Brain Circ. 2024 Sep 13;11(4):301-308. doi: 10.4103/bc.bc_41_24. eCollection 2025 Oct-Dec.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Heparin, Heparin Sodium Injection and No heparinization in people with Cerebral Angiography and Heparinization, run by Xuanwu Hospital, Beijing at 2 sites 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 9 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: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
postoperative cerebral infarction (time frame: Perioperative period). 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 NCT06365398, which also lists 1 linked publication.
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 Apr 2024.