NCT03379285

Brief Summary

Gastro intestinal (GI) bleeding is relatively frequent and may lead to intensive care unit admission. Although a restrictive strategy for red blood cell transfusion is supported by a large randomized controlled trial literature, less is known about the impact of transfusion strategy of other blood components and administration of anti fibrinolytic on clinical outcomes. This study aims to identify parameters that may be associated with the risk of further bleeding in patients admitted to ICU for GI bleeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 3, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
Last Updated

December 20, 2017

Status Verified

October 1, 2017

Enrollment Period

3 months

First QC Date

November 23, 2017

Last Update Submit

December 15, 2017

Conditions

Gastro Intestinal Bleeding

Keywords

Gastro Intestinal Bleeding;Transfusion,Outcomes

Outcome Measures

Primary Outcomes (1)

  • Bleeding

    Bleeding persistance or recidive requiring an intervention or a scope

    within a week

Secondary Outcomes (1)

  • mortality

    during hospitalisation (28 days)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to intensive care unit with the primary admission diagnosis of Gastro Intestinal Bleeding and who were not retrieved from another hospital.

You may qualify if:

  • Patients with Gastro Intestinal Bleeding admitted to either medical or surgical intensive care unit

You may not qualify if:

  • patients retrieved from another hospital
  • age \< 18 years consent withdrawal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2017

First Posted

December 20, 2017

Study Start

October 3, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

December 20, 2017

Record last verified: 2017-10

Locations

FR(1)