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Completed

NCT Number: NCT05446116

Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism

The present study aimes at comparing the transradial and transfemoral approaches for partial splenic embolization in patients with hypersplenism.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Zagazig university

Zagazig, Egypt

About this study

Since its development in 1979, partial splenic embolization (PSE) has been universally accepted to treat patients with hypersplenism in preference to surgical splenectomy. The spleen is the primary source of antibodies, lymphocyte production, and responsible for phagocytosis of white cells. Additionally, it plays an essential role in the immune system. Unlike splenectomy, partial splenic embolization (PSE) maintained partial splenic function and was thought to be an effective alternative to treat thrombocytopenia and leukopenia resulted from hypersplenism with fewer complications.

PSE is usually performed using a femoral artery approach that requires bed rest for a few hours. Recently, the transradial approach, with less obvious need for bed rest, has been more widely applied for cardiovascular intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with hypersplenism and severe thrombocytopenia (platelet count < 50,000/mm3).
  • the functional status of the liver should be Child A or early B according to Child-Pugh classification (5-7 points) (albumin ≥ 2.8 g/dL, bilirubin ≤ 3 mg/dL, prothrombin time ≤ 4 or INR < 1.7, no ascites, no encephalopathy).
  • Eligible for both femoral and radial puncture.

Exclusion criteria

  • Patients referred for embolization as treatment of traumatic splenic injury.
  • Patients lost during follow-up.

Treatment and study plan

partial splenic artery embolization

Procedure

embolization of the splenic artery for the treatment of hypersplenism

Primary outcomes

  1. Technical Success of the Procedure

    Time frame: Immediately after the procedure is complete

    The achievement of a single puncture allowing access to splenic artery without periprocedural complications.

  2. Average number of punctures

    Time frame: Immediately after the procedure is complete

    Number of arterial punctures required to complete the procedure

  3. Procedural time

    Time frame: Immediately after the procedure is complete

    The time interval from starting the anaethesia till completion of the procedure

  4. X-ray exposure duration

    Time frame: Immediately after the procedure is complete

    Duration of flouroscopy exposure during the procedure

  5. Length of hospital stay

    Time frame: 7 days

    Number of days that the patient will spend in the hospital after the procedure.

  6. Complications at access site

    Time frame: 30 days

    Access site adverse events such as vessel thrombosis, pseudoaneurysm or bleeding.

Secondary outcomes

  1. Procedural complications

    Time frame: 30 days

    Adverse events related to the procedure itself like splenic abscess, ascitis or portal vein thrombosis

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism, a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 6, 2022
Registry last updated
Jul 6, 2022

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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