Comparison of Mortality Impact of Coagulation Rotative Th... | NCT03703323

Studies
Comparison of Mortality Impact of Coagulation Rotative Thromboelastometry Analysis Versus Standard Analysis

NCT03703323

Sponsor

Centre Hospitalier Régional Metz-Thionville

Status

Terminated

Last Update Posted

Nov 30, 2021Actual

Enrollment

13Actual

Phase

Not Applicable

Conditions

Hemorrhage

Interventions

Rotative thromboelastometry analysis

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

pandemic situation

Expanded Access Info

Start Date

Oct 8, 2018Actual

Primary Completion Date

Aug 8, 2020Actual

Completion Date

Aug 21, 2020Actual

First Submitted Date

Oct 9, 2018

First Submission Date that Met QC Criteria

Oct 9, 2018

First Posted Date

Oct 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2021

Last Update Posted Date

Nov 30, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Standard technique of coagulation analysis (prothrombin ratio, activated partial thromboplastin time, fibrinogen and platelet count) do not provide to guide practitioner in reanimation of hemostatic patients in particular when coagulation defect preexisting to the digestive hemorrhage.

In this respect, the main objective of this study is to evaluate the interest of rotative thromboelastometry in the care of patient with digestive hemorrhage and its mortality impact.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Rotative thromboelastometry analysis	Other	Obtaining blood sample (one tube of blood)	Rotative thromboelastometry analysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	28-day mortality rate	day 28

Secondary Outcomes

Measure	Description	Time Frame
Fresh-frozen plasma	Number of fresh-frozen plasma used within the first 48 hours of the care	day 2
Length of stay	Lenght of stay in reanimation unit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CHR Metz Thionville		Metz		57085	France

Condition Browse Module

MeSH Terms

ID	Term
D006470	Hemorrhage

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided