Traumatic Splenic Injury and Management (SPLENIQ Study)

NCT03099798 | Completed

• 1 other identifier: NL54542.028.16 / P1609
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 10

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.

Conditions

Quality of Life; Spleen Injury; Trauma; Splenic Artery Embolization

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• Clinical Outcome

  One year follow-up

• Cost-effectiveness

  One year follow-up

• Imaging Outcome after Embolization (one month after treatment)

  One month after embolization

• Imaging Outcome after Embolization (one year after treatment)

  One year after embolization

• Splenic Artery Embolization characteristics

  One year follow-up

Study Arms (3)

Non-Operative Management (NOM)/Observational

Patients "treated" observationally for (traumatic) spleen injury.

Other: Questionnaires

Splenic Artery Embolization

Patients treated with splenic artery embolization for (traumatic) spleen injury.

Other: Questionnaires; Diagnostic Test: MRI abdomen

Surgery

Patients treated surgically for (traumatic) spleen injury.

Other: Questionnaires

Interventions

Questionnaires OTHER

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

Non-Operative Management (NOM)/Observational; Splenic Artery Embolization; Surgery

MRI abdomen DIAGNOSTIC_TEST

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

Splenic Artery Embolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• years or older.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elisabeth-TweeSteden Ziekenhuis: lead
• Erasmus Medical Center: collaborator
• Maasstad Hospital: collaborator
• Albert Schweitzer Hospital: collaborator
• Amphia Hospital: collaborator
• Tilburg University: collaborator
• Leiden University Medical Center: collaborator
• Amsterdam UMC, location VUmc: collaborator
• Medisch Spectrum Twente: collaborator
• Radboud University Medical Center: collaborator
• Isala: collaborator

Study Sites (10)

Radboud University Medical Center

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Amphia Hospital

Breda, North Brabant, 4800 RL, Netherlands

Location

Elisabeth-Twee Steden Hospital

Tilburg, North Brabant, 5000 LC, Netherlands

Location

VU University Medical Center

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Medical Spectrum Twente

Enschede, Overijssel, 7512 KZ, Netherlands

Location

Isala

Zwolle, Overijssel, 8025 AB, Netherlands

Location

Albert Schweitzer Hospital

Dordrecht, South Holland, 3300 AK, Netherlands

Location

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

Erasmus MC

Rotterdam, South Holland, 3000 CA, Netherlands

Location

Maasstad Hospital

Rotterdam, South Holland, 3007 AC, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 31066709 DERIVED

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jolanda de Vries, Prof. dr.

  Project leader (ETZ Tilburg, Tilburg University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 4, 2017
• Study Start: March 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (10)