Traumatic Splenic Injury and Management (SPLENIQ Study) (SPLENIQ)

Traumatic Splenic Injury and Management (SPLENIQ Study) Quality of Life and Clinical Outcomes of Treatment for Splenic Injury After Trauma

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Trauma; Spleen Injury; Splenic Artery Embolization
• Intervention / Treatment: Other: Questionnaires; Diagnostic test: MRI abdomen

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboud University Medical Center
  • Noord-Brabant
    • Breda, Noord-Brabant, Netherlands, 4800 RL
      • Amphia Hospital
    • Tilburg, Noord-Brabant, Netherlands, 5000 LC
      • Elisabeth-Twee Steden Hospital
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081 HV
      • VU University Medical Center
  • Overijssel
    • Enschede, Overijssel, Netherlands, 7512 KZ
      • Medical spectrum Twente
    • Zwolle, Overijssel, Netherlands, 8025 AB
      • Isala
  • Zuid-Holland
    • Dordrecht, Zuid-Holland, Netherlands, 3300 AK
      • Albert Schweitzer Hospital
    • Leiden, Zuid-Holland, Netherlands, 2333 ZA
      • Leiden University Medical Center
    • Rotterdam, Zuid-Holland, Netherlands, 3000 CA
      • Erasmus MC
    • Rotterdam, Zuid-Holland, Netherlands, 3007 AC
      • Maasstad Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-Operative Management (NOM)/Observational; Patients "treated" observationally for (traumatic) spleen injury.	Other: Questionnaires; All patients will complete a number of questionnaires at different time points.; SF-12, WHOQoL-Bref, EQ-5D-5L, iPCQ, iMCQ; 1 week, 1 month, 3, 6 and 12 months after treatment
Splenic Artery Embolization; Patients treated with splenic artery embolization for (traumatic) spleen injury.	Other: Questionnaires; All patients will complete a number of questionnaires at different time points.; SF-12, WHOQoL-Bref, EQ-5D-5L, iPCQ, iMCQ; 1 week, 1 month, 3, 6 and 12 months after treatment; Diagnostic test: MRI abdomen; Patients who were treated with splenic artery embolization will also undergo an MRI one month and one year after treatment.
Surgery; Patients treated surgically for (traumatic) spleen injury.	Other: Questionnaires; All patients will complete a number of questionnaires at different time points.; SF-12, WHOQoL-Bref, EQ-5D-5L, iPCQ, iMCQ; 1 week, 1 month, 3, 6 and 12 months after treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life: baseline (within 1 week after treatment)	WHOQoL-Bref questionnaire, SF-12 and EQ-5D-5L questionnaires	One week after treatment
Quality of life: 1 month follow-up	WHOQoL-Bref questionnaire	One month after treatment
Quality of life: 3 months follow-up	WHOQoL-Bref questionnaire	Three months after treatment
Quality of life: 6 months follow-up	WHOQoL-Bref questionnaire	Six months after treatment
Quality of life: one year follow-up	WHOQoL-Bref questionnaire	One year after treatment
Change in health status: SF-12	SF-12 questionnaire	One week, 1 month and 3, 6 and 12 months after treatment
Change in health related quality of life: EQ-5D-5L	EQ-5D-5L questionnaire	One week, 1 month and 3, 6 and 12 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcome	Data obtained from the patient records (e.g. complications, need for re-intervention, hospital stay, return to daily activities)	One year follow-up
Cost-effectiveness	The overall cost-effectiveness will be assessed with the iPCQ and iMCQ questionnaires, completed at different time points	One year follow-up
Imaging Outcome after Embolization (one month after treatment)	Splenic morphological characteristics (e.g. volume, necrosis, splenosis, calcifications or chronic infarction morphology)	One month after embolization
Imaging Outcome after Embolization (one year after treatment)	Splenic morphological characteristics (e.g.volume, necrosis, splenosis, calcifications or chronic infarction morphology)	One year after embolization
Splenic Artery Embolization characteristics	Difference between proximal versus distal embolization	One year follow-up
Prognostic factors for failure of Non-Operative Management	A recent study suggests that there are prognostic factors for failure of NOM in the treatment of adults with (blunt) splenic injury. Strong evidence exists for: age of 40 years or above, Injury Severity Score (ISS) of 25 or greater and American Association for the Surgery of Trauma (AAST) splenic injury grade of 3 or greater.	One year follow-up

Collaborators and Investigators

• Sponsor: Elisabeth-TweeSteden Ziekenhuis
• Collaborators: Radboud University Medical Center; Erasmus Medical Center; Amsterdam UMC, location VUmc; Leiden University Medical Center; Tilburg University; Albert Schweitzer Hospital; Maasstad Hospital; Isala; Medisch Spectrum Twente; Amphia Hospital
• Investigators: Principal Investigator: Jolanda de Vries, Prof. dr., Project leader (ETZ Tilburg, Tilburg University)

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info
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Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: NL54542.028.16 / P1609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No