protocolSection identificationModule nctId: NCT06365398, orgStudyIdInfo id: SELECT, secondaryIdInfos id: XWHL-2018010, type: OTHER_GRANT, domain: Xuanwu Hospital, Capital Medical University, briefTitle: Safety and Efficacy of Low-dose hEparinization in Cerebral Angiography sTudy, acronym: SELECT, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-01-01, primaryCompletionDateStruct date: 2021-06-01, completionDateStruct date: 2022-01-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Xuanwu Hospital, Beijing, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Cerebral Angiography, conditions: Heparinization, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ACTUAL, armsInterventionsModule interventions name: Heparin, interventions name: Heparin Sodium Injection, interventions name: No heparinization, outcomesModule primaryOutcomes measure: postoperative cerebral infarction, secondaryOutcomes measure: Numerical Rating Scale (NRS) for back pain, secondaryOutcomes measure: the incidence of paralysis of surgical limb, secondaryOutcomes measure: the incidence of pain of surgical limb, secondaryOutcomes measure: the incidence of postoperative urethral catheterization, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xuanwu Hospital, Capital Medical University, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Xuanwu Hospital, Capital Medical University., city: Beijing, zip: 100053, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False