Skip to content

Splenic Artery Injuries and the need for Vaccination after Embolisation

Splenic Artery Injuries and the need for Vaccination after Embolisation - the SAVE study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39016
Enrollment
32
Registered
2013-07-04
Start date
2013-08-29
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

letsel van de milt na trauma Splenic trauma

Interventions

Vaccination

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
1. Immunological: the antibody response to polysaccharide antigens, before and after administration of the Pneumo-23® vaccine, and 2. haematological: the presence and quantification of Howell-Jolly Bodies in peripheral blood.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)