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Quality of LifeSPLENIQNCT03099798

Traumatic Splenic Injury and Management (SPLENIQ Study)

An observational study of Quality of Life and Spleen Injury, run by Elisabeth-TweeSteden Ziekenhuis at 10 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Quality of Life, Spleen Injury, Trauma
What is being tested?
Questionnaires and MRI abdomen
How many people
106 participants
Where
10 sitesNetherlands
Study dates
1 Mar 2017to 31 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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
  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Netherlands10 sites

  • VU University Medical Center

    Amsterdam, North Holland, 1081 HV

  • Amphia Hospital

    Breda, North Brabant, 4800 RL

  • Albert Schweitzer Hospital

    Dordrecht, South Holland, 3300 AK

  • Medical Spectrum Twente

    Enschede, Overijssel, 7512 KZ

  • Leiden University Medical Center

    Leiden, South Holland, 2333 ZA

  • Radboud University Medical Center

    Nijmegen, Gelderland, 6525 GA

  • Erasmus MC

    Rotterdam, South Holland, 3000 CA

  • Maasstad Hospital

    Rotterdam, South Holland, 3007 AC

  • Elisabeth-Twee Steden Hospital

    Tilburg, North Brabant, 5000 LC

  • Isala

    Zwolle, Overijssel, 8025 AB

Other trials in Netherlands

About this study

Official title: 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.

Read more

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.

Being tested
Questionnaires, MRI abdomen
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnairesOther

    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

  • MRI abdomenDiagnostic test

    Patients who were treated with splenic artery embolization will also undergo an MRI one month and one year after treatment.

Study groups in NCT03099798
Study groupRoleWhat they receive
Non-Operative Management (NOM)/ObservationalPatients "treated" observationally for (traumatic) spleen injury.
Receives: Other: Questionnaires
Splenic Artery EmbolizationPatients treated with splenic artery embolization for (traumatic) spleen injury.
Receives: Other: Questionnaires; Diagnostic Test: MRI abdomen
SurgeryPatients treated surgically for (traumatic) spleen injury.
Receives: Other: Questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Life: baseline (within 1 week after treatment)

    WHOQoL-Bref questionnaire, SF-12 and EQ-5D-5L questionnaires

    Measured: One week after treatment

  2. Quality of life: 1 month follow-up

    WHOQoL-Bref questionnaire

    Measured: One month after treatment

  3. Quality of life: 3 months follow-up

    WHOQoL-Bref questionnaire

    Measured: Three months after treatment

  4. Quality of life: 6 months follow-up

    WHOQoL-Bref questionnaire

    Measured: Six months after treatment

  5. Quality of life: one year follow-up

    WHOQoL-Bref questionnaire

    Measured: One year after treatment

  6. Change in health status: SF-12

    SF-12 questionnaire

    Measured: One week, 1 month and 3, 6 and 12 months after treatment

  7. Change in health related quality of life: EQ-5D-5L

    EQ-5D-5L questionnaire

    Measured: One week, 1 month and 3, 6 and 12 months after treatment

Secondary outcomes (6)

  1. Clinical Outcome

    Data obtained from the patient records (e.g. complications, need for re-intervention, hospital stay, return to daily activities)

    Measured: One year follow-up

  2. Cost-effectiveness

    The overall cost-effectiveness will be assessed with the iPCQ and iMCQ questionnaires, completed at different time points

    Measured: One year follow-up

  3. Imaging Outcome after Embolization (one month after treatment)

    Splenic morphological characteristics (e.g. volume, necrosis, splenosis, calcifications or chronic infarction morphology)

    Measured: One month after embolization

  4. Imaging Outcome after Embolization (one year after treatment)

    Splenic morphological characteristics (e.g.volume, necrosis, splenosis, calcifications or chronic infarction morphology)

    Measured: One year after embolization

  5. Splenic Artery Embolization characteristics

    Difference between proximal versus distal embolization

    Measured: One year follow-up

  6. 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.

    Measured: One year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2017
  2. Study start1 Mar 2017
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03099798
Sponsor's protocol ID
NL54542.028.16 / P1609
Acronym
SPLENIQ
Status last verified
Mar 2022
First submitted
22 Mar 2017
Last updated
1 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 31066709

Questions about this trial

What is this clinical trial studying?

An observational study of Quality of Life and Spleen Injury, run by Elisabeth-TweeSteden Ziekenhuis at 10 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life: baseline (within 1 week after treatment) (time frame: One week after treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03099798, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022; AzTrials last refreshed its copy on 31 Oct 2026.

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