Clinical trial NCT03099798: Traumatic Splenic Injury and Management (SPLENIQ Study)
Official title: Traumatic Splenic Injury and Management (SPLENIQ Study) Quality of Life and Clinical Outcomes of Treatment for Splenic Injury After Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Spleen Injury
Trauma
Splenic Artery Embolization
Lead sponsor: Elisabeth-TweeSteden Ziekenhuis
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: Maasstad Hospital
name: Albert Schweitzer Hospital
name: Amphia Hospital
name: Tilburg University
name: Leiden University Medical Center
name: Amsterdam UMC, location VUmc
name: Medisch Spectrum Twente
name: Radboud University Medical Center
name: Isala
First posted: 2017-04-04
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with splenic injury after blunt abdominal trauma confirmed by ultrasound (US/FAST) and/or computed tomography (CT) at the primary trauma screening at the 5 selected hospitals between March 2017 and December 2018 will be asked to participate in this study as soon as they can talk and are lucid. Patients receive a verbal and written explanation about the study. The time for consideration is one week. When a patient is willing to participate he/she will be asked to sign a consent form. When patients agree to participate, they are included for follow-up.

Brief summary: OBJECTIVE:

To determine the quality of life (QOL) and clinical outcome after conservative therapy, embolization (proximal versus distal) or surgery in patients with traumatic splenic injury. Secondary aims: (I) to examine therapy-related complications, (II) to establish the necessity of additional therapies, (III) the assessment of splenic function related to splenic morphology (MR imaging) after embolization and (IV) to find the prognostic factors for failure of non-operative management (NOM) in patients with splenic injuries. Finally, with the acquired data from this study a patient-oriented protocol will be provided for the management of traumatic splenic injury.

HYPOTHESIS:

The investigators expect that NOM is superior to surgery with regard to QOL, clinical outcome and splenic function. Embolization will need more additional therapies. Splenic morphology is related to splenic immune function. Expected prognostic factors are age above 40, ISS \>25 and a splenic injury grade of 3 or higher.

STUDY DESIGN:

A combination of a retrospective and a prospective multicentre cohort study. This protocol involves the prospective part of the study.

STUDY POPULATION/DATASET:

Patients who enter the participating hospitals between March 2017 and December 2018 with splenic injury will be asked to participate. The follow-up period will be one year with regard to QOL, clinical symptoms and imaging.

INTERVENTION:

All patients will complete a number of questionnaires at different time points. The patients who were treated with splenic artery embolization (SAE) will undergo an MRI one month and one year after treatment.

OUTCOME MEASURES:

Primary outcome is QOL. Secondary outcomes are clinical symptoms and imaging.

SAMPLE SIZE:

Approximately 100 patients will be included per year during the inclusion phase.

DATA ANALYSIS:

With regard to the prospective data linear modelling will be performed.

COLLABORATION/CONNECTION:

Tilburg University, Erasmus Medical Center Rotterdam, Maasstad Hospital Rotterdam, Albert Schweitzer Hospital Dordrecht, Amphia hospital Breda, Leiden University Medical Center, VU University Medical Center Amsterdam, Medical Spectrum Twente, Radboud University Nijmegen, Isala Zwolle.

TIME SCHEDULE:

Year 1: literature search and conducting the retrospective study and analyses. Years 1-3: inclusion prospective study and follow-up of patients. Year 4: finishing follow-up data collection and analysing.


Eligibility criteria: Inclusion Criteria:

* Splenic injury after blunt abdominal trauma (confirmed by FAST and/or CT)
* The patient underwent NOM/SAE/splenectomy for the management of traumatic splenic injury
* The treatment took place in the period from March 2017 to December 2018 at one of the five selected hospitals
* 18 years or older.

Exclusion Criteria:

* Insufficient knowledge of the Dutch language
* Patients who died during or after treatment are (of course) excluded for questionnaires and MRI, not for clinical outcomes

Exclusion for MRI only:

- Patients treated with SAE: patients who do not want to or are not able to undergo an MRI abdomen (for example pregnant women or other contraindications for MRI). Patients excluded for MRI still need to fill out the questionnaires. Also, their clinical outcomes will be processed in the database.

Primary outcomes:
measure: Quality of Life: baseline (within 1 week after treatment)
timeFrame: One week after treatment
measure: Quality of life: 1 month follow-up
timeFrame: One month after treatment
measure: Quality of life: 3 months follow-up
timeFrame: Three months after treatment
measure: Quality of life: 6 months follow-up
timeFrame: Six months after treatment
measure: Quality of life: one year follow-up
timeFrame: One year after treatment
measure: Change in health status: SF-12
timeFrame: One week, 1 month and 3, 6 and 12 months after treatment
measure: Change in health related quality of life: EQ-5D-5L
timeFrame: One week, 1 month and 3, 6 and 12 months after treatment
Secondary outcomes:
measure: Clinical Outcome
timeFrame: One year follow-up
measure: Cost-effectiveness
timeFrame: One year follow-up
measure: Imaging Outcome after Embolization (one month after treatment)
timeFrame: One month after embolization
measure: Imaging Outcome after Embolization (one year after treatment)
timeFrame: One year after embolization
measure: Splenic Artery Embolization characteristics
timeFrame: One year follow-up
measure: Prognostic factors for failure of Non-Operative Management
timeFrame: One year follow-up
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
state: Gelderland
city: Breda
country: Netherlands
facility: Amphia Hospital
state: Noord-Brabant
city: Tilburg
country: Netherlands
facility: Elisabeth-Twee Steden Hospital
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
state: Noord-Holland
city: Enschede
country: Netherlands
facility: Medical Spectrum Twente
state: Overijssel
city: Zwolle
country: Netherlands
facility: Isala
state: Overijssel
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital
state: Zuid-Holland
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
state: Zuid-Holland
Study officials:
affiliation: Project leader (ETZ Tilburg, Tilburg University)
name: Jolanda de Vries, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raaijmakers CP, Lohle PN, Lodder P, de Vries J. Quality of Life and Clinical Outcome After Traumatic Spleen Injury (SPLENIQ Study): Protocol for an Observational Retrospective and Prospective Cohort Study. JMIR Res Protoc. 2019 Apr 26;8(5):e12391. doi: 10.2196/12391.