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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099798
Recruitment Status : Active, not recruiting
First Posted : April 4, 2017
Last Update Posted : August 14, 2020
Sponsor:
Collaborators:
Erasmus Medical Center
Maasstad Hospital
Albert Schweitzer Hospital
Amphia Hospital
University of Tilburg
Leiden University Medical Center
VU University Medical Center
Medisch Spectrum Twente
Radboud University
Isala
Information provided by (Responsible Party):
Elisabeth-TweeSteden Ziekenhuis

Tracking Information
First Submitted Date March 22, 2017
First Posted Date April 4, 2017
Last Update Posted Date August 14, 2020
Actual Study Start Date March 1, 2017
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 28, 2017)
  • 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
  • Quality of life: 1 month follow-up [ Time Frame: One month after treatment ]
    WHOQoL-Bref questionnaire
  • Quality of life: 3 months follow-up [ Time Frame: Three months after treatment ]
    WHOQoL-Bref questionnaire
  • Quality of life: 6 months follow-up [ Time Frame: Six months after treatment ]
    WHOQoL-Bref questionnaire
  • Quality of life: one year follow-up [ Time Frame: One year after treatment ]
    WHOQoL-Bref questionnaire
  • Change in health status: SF-12 [ Time Frame: One week, 1 month and 3, 6 and 12 months after treatment ]
    SF-12 questionnaire
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 28, 2017)
  • 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)
  • 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
  • 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)
  • 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)
  • Splenic Artery Embolization characteristics [ Time Frame: One year follow-up ]
    Difference between proximal versus distal embolization
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Quality of Life
  • Spleen Injury
  • Trauma
  • Splenic Artery Embolization
Intervention
  • 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.
Study Groups/Cohorts
  • Non-Operative Management (NOM)/Observational
    Patients "treated" observationally for (traumatic) spleen injury.
    Intervention: Other: Questionnaires
  • Splenic Artery Embolization
    Patients treated with splenic artery embolization for (traumatic) spleen injury.
    Interventions:
    • Other: Questionnaires
    • Diagnostic Test: MRI abdomen
  • Surgery
    Patients treated surgically for (traumatic) spleen injury.
    Intervention: Other: Questionnaires
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: February 13, 2019)
106
Original Estimated Enrollment
 (submitted: March 28, 2017)
100
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT03099798
Other Study ID Numbers NL54542.028.16 / P1609
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Elisabeth-TweeSteden Ziekenhuis
Study Sponsor Elisabeth-TweeSteden Ziekenhuis
Collaborators
  • Erasmus Medical Center
  • Maasstad Hospital
  • Albert Schweitzer Hospital
  • Amphia Hospital
  • University of Tilburg
  • Leiden University Medical Center
  • VU University Medical Center
  • Medisch Spectrum Twente
  • Radboud University
  • Isala
Investigators
Principal Investigator: Jolanda de Vries, Prof. dr. Project leader (ETZ Tilburg, Tilburg University)
PRS Account Elisabeth-TweeSteden Ziekenhuis
Verification Date July 2020