NCT03464513

Brief Summary

Lower gastrointestinal bleeding occurs distal to the ligament of treitz and may involve the small bowel, colon and rectum . Active lower gastrointestinal bleeding is a common, potentially life threatening medical presentation that can be challenging to localize and treat . There are many diseases that may cause lower gastrointestinal bleeding, including angiodysplasia, diverticulosis, benign or malignant bowel neoplasm, inflammatory bowel disease, ischemic bowel disease, and infectious bowel disease. Often, gastrointestinal bleeding will stop spontaneously, but in approximately 25% of patients, bleeding is massive or recurrent, requiring imaging localization and directed therapy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

February 23, 2018

Last Update Submit

March 7, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • MSCTA in the evaluation of patients presenting with active lower gastrointestinal bleeding.

    Multislice ct angiography

    1 hour

Study Arms (1)

Patients with GIT bleeding

OTHER

Patients with active lower Gastrointestinal bleeding

Device: Multislice CT Angiography

Interventions

Multislice CT angiography (MSCTA) provides a relatively non-invasive and effective way of localising the source of bleeding, especially in patients with continuous bleeding.

Patients with GIT bleeding

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting to assiut university hospital with active lower gastrointestinal bleeding.

You may not qualify if:

  • Patients whom are sensitive to contrast. Pregnant women. Patients with renal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yoon W, Jeong YY, Shin SS, Lim HS, Song SG, Jang NG, Kim JK, Kang HK. Acute massive gastrointestinal bleeding: detection and localization with arterial phase multi-detector row helical CT. Radiology. 2006 Apr;239(1):160-7. doi: 10.1148/radiol.2383050175. Epub 2006 Feb 16.

    PMID: 16484350BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 14, 2018

Study Start

April 1, 2018

Primary Completion

April 1, 2019

Study Completion

April 1, 2020

Last Updated

March 14, 2018

Record last verified: 2018-03