To compare splenic function between patients who received splenectomy and patients treated with embolisation. Furthermore, splenic function between patients with different types of embolisation (proximal versus distal) will be compared
ID
Source
Brief title
Condition
- Other condition
- Bacterial infectious disorders
Synonym
Health condition
letsel van de milt na trauma
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
not applicable
Background summary
The spleen is one of the most commonly injured organs after blunt trauma and
formerly splenectomy was the most applied treatment strategy. The risk of
Overwhelming Post-Splenectomy Infection (OPSI), a disorder carrying a mortality
of 50-70%, prompted the evolution toward more conservative treatment strategies
for the treatment of splenic injury. Nowadays, Splenic Artery Embolisation
(SAE) is increasingly being applied. Existing studies on immune function after
SAE are not sufficient for any firm conclusions to be drawn about preservation
of splenic immunocompetence. Furthermore, there has only been one study
comparing splenic function between different types of embolisation (proximal
versus distal) and very few patients were included in this study
Study objective
To compare splenic function between patients who received splenectomy and
patients treated with embolisation. Furthermore, splenic function between
patients with different types of embolisation (proximal versus distal) will be
compared
Study design
Experimental cohort study.
Intervention
Vaccination
Study burden and risks
Burden
Patients will be invited twice to the Academic Medical Centre (AMC). During the
first visit, patients will be vaccinated with Pneumo-23® after the collection
of blood samples (total of 24 ml). During the second visit, 14 days later,
again a total amount of 24 ml blood will be drawn by a single venous puncture.
Patients who are, for any reason, not capable to come the hospital will be
visited by the researcher at home.
Risks
Overall, potential risks associated with participation in the study are
categorised as *low risk*. A local haematoma may develop during blood sample
collection. In addition, there is a chance of developing a local reaction
(erythema, oedema, pain or tenderness) to vaccination. A small chance (0.1-1%)
exists that other side effects of vaccination occur. Symptoms include fever,
headache, myalgia and/or hypotension. This is not a severe complication since
awareness and accurate treatment is available.
Benefit
This aim of this study is to investigate whether patients who receive different
types of embolisation benefit from vaccination and to determine if this patient
cohort should receive prophylactic immunizations in the future. Benefits
include a protection against encapsulated bacteria and thereby a reduction in
the risk of developing Overwhelming Post-Splenectomy Infection (OPSI).
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44733.018.13 |