Cerebral Angiography, Heparinization
Conditions
Keywords
cerebral angiography, heparin, Nursing, Ischemic Stroke, Safety, Efficacy
Brief 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. 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.
Interventions
DRUGHeparin
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.
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.
OTHERNo heparinization
No additional heparin was administered via the sheath or arterial route in the no heparinization group.
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. aged 18-65 years; 2. suspected cerebrovascular disease, including vascular lesions of the carotid, middle cerebral, anterior cerebral, vertebral, basilar, and posterior cerebral arteries; 3. Activity of daily living (ADL) score between 85\ 100; 4. normal coagulation function and no prior anticoagulant therapy before DSA; 5. fully informed consent to participate in the study.
Exclusion criteria
1. iodine allergy; 2. hepatic and/or renal insufficiency; 3. severe hypertension with poor blood pressure control; 4. hemorrhagic diseases; 5. hyperlipidemia; 6. poor glycemic control in diabetes; 7. pregnancy; 8. atrial fibrillation; 9. undergoing interventional treatment simultaneously.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative cerebral infarction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale (NRS) for back pain | 24 hours after intervention | Numerical Rating Scale (NRS) for back pain is assessed by investigators after intervention |
| the incidence of paralysis of surgical limb | 24 hours after intervention | the incidence of paralysis is assessed after intervention |
| the incidence of pain of surgical limb | 24 hours after intervention | the incidence of pain of surgical limb is assessed after intervention |
| the incidence of postoperative urethral catheterization | 24 hours after intervention | the incidence of postoperative urethral catheterization is assessed after intervention. |
Countries
China
Outcome results
None listed