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Indicative factors for surgical or angiographic intervention for hemorrhagic complications in hemodynamically stable patients with blunt abdominal trauma

Status Approved

First Submitted Date

2021/01/04
Registered Date

2021/01/22
Last Updated Date

2021/01/13

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005808
Unique Protocol ID	CR320152
Public/Brief Title	Interventions for blunt abdominal trauma
Scientific Title	Indicative factors for surgical or angiographic intervention for hemorrhagic complications in hemodynamically stable patients with blunt abdominal trauma
Acronym	SAI
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	CR320152
Approval Date	2020-12-15
Institutional Review Board Name	Yonsei University Wonju Severance Christian Hospital Institutional Review Board
Institutional Review Board Address	20, Ilsan-ro, Wonju-si, Gangwon-do
Institutional Review Board Telephone	033-741-1703
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Jae Sik Chung
Title	MD
Telephone	+82-1333
Affiliation	Yonsei University, Wonju Severance Christian Hospital
Address	20, Ilsan-ro, Wonju-si, Gangwon-do
Contact Person for Public Queries
Name	Jae Sik Chung
Title	MD
Telephone	+82-1333
Affiliation	Yonsei University, Wonju Severance Christian Hospital
Address	20, Ilsan-ro, Wonju-si, Gangwon-do
Contact Person for Updating Information
Name	Jae Sik Chung
Title	MD
Telephone	+82-1333
Affiliation	Yonsei University, Wonju Severance Christian Hospital
Address	20, Ilsan-ro, Wonju-si, Gangwon-do

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2020-12-15 Actual
Target Number of Participant	250
Primary Completion Date	2020-12-30 , Actual
Study Completion Date	2021-01-01 , Actual
Name of Study	Yonsei University, Wonju Severance Christian Hospital
Recruitment Status	Completed
Date of First Enrollment	2020-12-15 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Yonsei University, Wonju Severance Christian Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Yonsei University, Wonju Severance Christian Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The standard of care for intraperitoneal injury in hemodynamically stable patients after blunt abdominal trauma has been replaced by non-operative management (NOM). However, selective NOM, depending on the situation, seems necessary in determining the treatment plan. In this study, we attempted to identify risk factors for surgical or angiographic intervention (SAI) in hemodynamically stable patients with blunt abdominal trauma.

Study Summary Information

Lay Summary

The standard of care for intraperitoneal injury in hemodynamically stable patients after blunt abdominal trauma has been replaced by non-operative management (NOM). However, selective NOM, depending on the situation, seems necessary in determining the treatment plan. In this study, we attempted to identify risk factors for surgical or angiographic intervention (SAI) in hemodynamically stable patients with blunt abdominal trauma.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Case-only
Time Perspective	Retrospective
Target Number of Participant	250
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Abdominal trauma patients
Cohort/ Group 1	Cohort/Group Description Data on hemodynamically stable blunt abdominal trauma patients who visited the regional trauma center during the study period were obtained through electronic medical record review.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Hemodynamically stable blunt abdominal trauma patients who visited our center during the study period
Sampling Method	electronic medical record review (Non-probablity sampling)
Condition(s)/Problem(s)	* (S00-T98)Injury, poisoning and certain other consequences of external causes (S39.9)Unspecified injury of abdomen, lower back and pelvis abdominal trauma
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~72Year
	Description Data on trauma patients who visited our center during the study period were obtained through electronic medical record review. The inclusion criteria for the present study were adult patients aged over 18 years who suffered blunt abdominal trauma and hemodynamically stable patients with clear consciousness.
Exclusion Criteria	The exclusion criteria were patients who did not undergo a CT scan due to unstable vital signs, patients who were lost to follow-up owing to transfer to other hospitals, patients in whom free air was observed on CT, patients in whom no damage was observed on CT, and those in whom the cause of intra-abdominal fluid collection was indistinguishable from medical causes (e.g., liver cirrhosis).
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Active bleeding
Timepoint	On trauma center
Secondary Outcome(s) 1
Outcome	eFAST
Timepoint	On trauma center

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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