A Phase 4 interventional study of Heparin and Heparin Sodium Injection in Cerebral Angiography and Heparinization, sponsored by Xuanwu Hospital, Beijing. Completed at 2 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-15.
Sponsored by Xuanwu Hospital, Beijing · Phase 4, Interventional, and Treatment
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.
Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.
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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.
Drug: Heparin
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.
Drug: Heparin Sodium Injection
No heparinization is performed with no additional heparin is administered by a sheath or arterial route in the third group.
Other: No 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.
Also known as: Regular-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.
Also known as: Micro-dose heparinization
No additional heparin was administered via the sheath or arterial route in the no heparinization group.
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.
Time frame: Perioperative period
Numerical Rating Scale (NRS) for back pain
Numerical Rating Scale (NRS) for back pain is assessed by investigators after intervention
Time frame: 24 hours after intervention
the incidence of paralysis of surgical limb
the incidence of paralysis is assessed after intervention
Time frame: 24 hours after intervention
the incidence of pain of surgical limb
the incidence of pain of surgical limb is assessed after intervention
Time frame: 24 hours after intervention
the incidence of postoperative urethral catheterization
the incidence of postoperative urethral catheterization is assessed after intervention.
Time frame: 24 hours after intervention
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Xuanwu Hospital, Beijing