NCT03703323

Brief Summary

Digestive hemorrhage is a common cause of acute hemorrhage in France, and its mortality remains high despite improvement of endoscopy technique and therapeutics. Hemostasis disorders are an important issue in the patient care both in severity diagnostic and therapeutic plan.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 9, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2020

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2020

Completed
Last Updated

November 30, 2021

Status Verified

January 1, 2021

Enrollment Period

1.8 years

First QC Date

October 9, 2018

Last Update Submit

November 29, 2021

Conditions

Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Mortality

    28-day mortality rate

    day 28

Secondary Outcomes (3)

  • Fresh-frozen plasma

    day 2

  • Length of stay

    day 28

  • Recurrent bleeding

    Day 2

Study Arms (1)

Rotative thromboelastometry analysis

EXPERIMENTAL

Evaluation of diagnostic properties of coagulation by rotative thromboelastometry in patient with digestive hemorrhage in predictive value of mortality.

Other: Rotative thromboelastometry analysis

Interventions

Rotative thromboelastometry analysisOTHER

Obtaining blood sample (one tube of blood)

Rotative thromboelastometry analysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized patient in reanimation unit or continuous monitoring for digestive hemorrhage before or immediately after digestive endoscopy
  • Digestive hemorrhage diagnostic: melena and/or rectal bleeding and/or hematemesis
  • Affiliation to the social security
  • Have signed an informed consent

You may not qualify if:

  • Pregnant or nursing woman
  • Without digestive fibroscopy
  • With an anticoagulant treatment
  • With a congenital coagulopathy
  • Decision of therapeutic limitation or moribund patient
  • With a digestive hemorrhage after an hospitalisation in reanimation unit for an other reason
  • Participation in an other study in previous 30 days
  • Under trusteeship, guardianship or judicial safeguards

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Metz Thionville

Metz, 57085, France

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2018

First Posted

October 11, 2018

Study Start

October 8, 2018

Primary Completion

August 8, 2020

Study Completion

August 21, 2020

Last Updated

November 30, 2021

Record last verified: 2021-01

Locations

FR(1)