Splenic Artery Injuries and the need for Vaccination after Embolisatio

Completed

• Conditions: letsel van de milt na trauma; Splenic trauma; injury to the spleen; 10004018

• Registration Number: NL-OMON39016
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

* Adult patients (*18 years old)
* Treated with embolisation for splenic injury after trauma , * 6 months ago
* Master the Dutch, English or French language and fully able to understand the information provided
* Voluntarily written informed consent

Exclusion Criteria

* Limited mental capacity or language skills such that explanations and instructions (regarding adverse events) cannot be followed
* Patients with splenic injury treated with observational management or splenic surgery (laparotomy with splenectomy or splenorrhaphy)
* Patients treated with a combination of proximal and distal embolisation
* Patients who have received a pneumococcal vaccine in the past 5 years
* Blood donation or blood loss greater than 400 ml in the last 3 months
* Participation in (an)other medical study(ies)
* Allergies for previously administered vaccines
* Patients with acute or chronic illness that may affect immunity
* Patients with comorbidity affecting splenic function (i.e. haematological or immunological diseases)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Immunological: the antibody response to polysaccharide antigens, before and<br /><br>after administration of the Pneumo-23® vaccine, and 2. haematological: the<br /><br>presence and quantification of Howell-Jolly Bodies in peripheral blood. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>