Clinical trial NCT06365398: Safety and Efficacy of Low-dose hEparinization in Cerebral Angiography sTudy
Official title: Safety and Efficacy of Low-dose Heparinization in Cerebral Angiography: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cerebral Angiography
Heparinization
Keywords: cerebral angiography
heparin
Nursing
Ischemic Stroke
Safety
Efficacy
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: postoperative cerebral infarction
timeFrame: Perioperative period
Secondary outcomes:
measure: Numerical Rating Scale (NRS) for back pain
timeFrame: 24 hours after intervention
measure: the incidence of paralysis of surgical limb
timeFrame: 24 hours after intervention
measure: the incidence of pain of surgical limb
timeFrame: 24 hours after intervention
measure: the incidence of postoperative urethral catheterization
timeFrame: 24 hours after intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University.
Study officials:
References: