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NCT Number: NCT06365398

Safety and Efficacy of Low-dose hEparinization in Cerebral Angiography 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.

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Key information

Conditions

Cerebral Angiography Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heparinization Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xuanwu Hospital, Capital Medical University, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • iodine allergy;
  • hepatic and/or renal insufficiency;
  • severe hypertension with poor blood pressure control;
  • hemorrhagic diseases;
  • hyperlipidemia;
  • poor glycemic control in diabetes;
  • pregnancy;
  • atrial fibrillation;
  • undergoing interventional treatment simultaneously.

Treatment and study plan

Heparin

Drug

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.

Other names: Regular-dose heparinization

Heparin sodium injection

Drug

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.

Other names: Micro-dose heparinization

No heparinization

Other

No additional heparin was administered via the sheath or arterial route in the no heparinization group.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Numerical Rating Scale (NRS) for back pain

    Time frame: 24 hours after intervention

    Numerical Rating Scale (NRS) for back pain is assessed by investigators after intervention

  2. the incidence of paralysis of surgical limb

    Time frame: 24 hours after intervention

    the incidence of paralysis is assessed after intervention

  3. the incidence of pain of surgical limb

    Time frame: 24 hours after intervention

    the incidence of pain of surgical limb is assessed after intervention

  4. the incidence of postoperative urethral catheterization

    Time frame: 24 hours after intervention

    the incidence of postoperative urethral catheterization is assessed after intervention.

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

Safety and Efficacy of Low-dose Heparinization in Cerebral Angiography: a Randomized Controlled Study

Acronym: SELECT

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Apr 15, 2024
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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