The Utility of Thromboelastography in Cirrhotic Patients... | NCT02990273

Studies
The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures

NCT02990273

Sponsor

Johns Hopkins University

Status

Terminated

Last Update Posted

Jan 22, 2021Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Cirrhosis, Coagulopathy

Interventions

Blood transfusion

Countries

Not provided

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

No funding source available which was required for IRB approval

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

Jan 19, 2021Actual

Completion Date

Jan 19, 2021Actual

First Submitted Date

Oct 14, 2016

First Submission Date that Met QC Criteria

Dec 8, 2016

First Posted Date

Dec 13, 2016Estimated

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

Jan 19, 2021

Last Update Posted Date

Jan 22, 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

Cirrhosis results in decreased synthesis of both procoagulants and anticoagulants resulting in "rebalanced homeostasis". However, conventional blood tests (platelets/ INR levels) that are performed prior to invasive procedures do not accurately reflect the coagulation changes that occur in cirrhotics, resulting in unnecessary transfusion of blood products. Thromboelastography (TEG) is a global hemostasis assessment tool that is being used in surgery (including liver transplant) to help guide blood product transfusion in the operating room. The investigators would like to compare the use of TEG vs. INR/platelets to help guide blood product transfusion in cirrhotic patients undergoing inpatient endoscopy. The investigators will evaluate to see if there is a decrease in prophylactic blood transfusions prior to endoscopy when using TEG.

Detailed Description

Not provided

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

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TEG	Active Comparator	Blood transfusion	Biological: Blood transfusion
Prothrombin Time (PT)/International normalized ratio (INR)	Active Comparator	Blood transfusion	Biological: Blood transfusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood transfusion	Biological		Prothrombin Time (PT)/International normalized ratio (INR) TEG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Units of fresh frozen plasma (FFP) and platelet transfused	Will compare how much FFP and platelet transfusion patients receiving between 2 groups.	2 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All 18 yo + cirrhotic patients who are being scheduled for inpatient endoscopy

Exclusion Criteria:

Patients on blood thinners (prophylactic anticoagulation is permissible)
Hemodynamically unstable patients requiring pressors (ie ICU level patients)
Pregnant or lactating individuals
Inability to provide consent for any reason

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

Name	Affiliation	Role
Tinsay Woreta	Johns Hopkins University	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis
D020141	Hemostatic Disorders

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001803	Blood Transfusion

Ancestor Terms

ID	Term
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided