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

March 31, 2022 updated by: Elisabeth-TweeSteden Ziekenhuis

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality of Life: baseline (within 1 week after treatment)
Time Frame: One week after treatment
WHOQoL-Bref questionnaire, SF-12 and EQ-5D-5L questionnaires
One week after treatment
Quality of life: 1 month follow-up
Time Frame: One month after treatment
WHOQoL-Bref questionnaire
One month after treatment
Quality of life: 3 months follow-up
Time Frame: Three months after treatment
WHOQoL-Bref questionnaire
Three months after treatment
Quality of life: 6 months follow-up
Time Frame: Six months after treatment
WHOQoL-Bref questionnaire
Six months after treatment
Quality of life: one year follow-up
Time Frame: One year after treatment
WHOQoL-Bref questionnaire
One year after treatment
Change in health status: SF-12
Time Frame: One week, 1 month and 3, 6 and 12 months after treatment
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
Time Frame: One week, 1 month and 3, 6 and 12 months after treatment
EQ-5D-5L questionnaire
One week, 1 month and 3, 6 and 12 months after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Outcome
Time Frame: One year follow-up
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
Time Frame: One year follow-up
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)
Time Frame: One month after embolization
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)
Time Frame: One year after embolization
Splenic morphological characteristics (e.g.volume, necrosis, splenosis, calcifications or chronic infarction morphology)
One year after embolization
Splenic Artery Embolization characteristics
Time Frame: One year follow-up
Difference between proximal versus distal embolization
One year follow-up
Prognostic factors for failure of Non-Operative Management
Time Frame: One year follow-up
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elisabeth-TweeSteden Ziekenhuis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jolanda de Vries, Prof. dr., Project leader (ETZ Tilburg, Tilburg University)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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