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Thromboelastography for Cardiovascular and Lung Diseases
N/A
Waitlist Available
Led By Stephen Esper, MD, MBA
Research Sponsored by Stephen Esper
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient's requiring ECMO placement
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time patient is placed on ecmo to 30-days post ecmo initiation
Awards & highlights
Study Summary
This trial will test whether using a special algorithm, in addition to standard laboratory tests, can help manage blood transfusions and clotting for ECMO patients.
Who is the study for?
This trial is for patients who need ECMO (a life-support machine that helps the heart and lungs function) due to lung or heart disease. It's open to adults of any age, but children under 18 cannot participate.Check my eligibility
What is being tested?
The study is testing whether using a TEG algorithm—a way to measure blood clotting—can help manage bleeding and clotting issues better than just traditional lab tests in patients on ECMO.See study design
What are the potential side effects?
Since this trial focuses on monitoring with TEG rather than a new medication, side effects are related to potential changes in transfusion or anticoagulation management as guided by the TEG results.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You need to have a machine called ECMO put in your body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time patient is placed on ecmo to 30-days post ecmo initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time patient is placed on ecmo to 30-days post ecmo initiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants whose blood management care follows a TEG algorithm 90% of the time
Secondary outcome measures
Chest tube output and overall estimated blood loss
Need for surgical intervention for hemorrhage
Number of participants that experience bleeding or thrombotic-related adverse events, including deep venous thrombosis or pulmonary embolus
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Pilot ArmExperimental Treatment1 Intervention
All subjects enrolled in the trial will be in the pilot group. These subjects will have traditional laboratory coagulation and blood transfusion tests (baseline arterial blood gas (ABG), complete blood count (CBC), fibrinogen, platelet count, aPTT, PT, anti-Xa, ACT), as well as thromboelastograph (TEG). Pertinent TEG results will include: heparinase-kaolin TEG maximum amplitude (MA) in millimeters (mm), heparinase-kaolin TEG r-time in seconds, heparinase-kaolin TEG alpha angle in degrees, and TEG functional fibrinogen (FLEV) MA in mm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thromboelastograph
2017
N/A
~20
Find a Location
Who is running the clinical trial?
Stephen EsperLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
American Heart AssociationOTHER
319 Previous Clinical Trials
4,932,407 Total Patients Enrolled
Stephen Esper, MD, MBAPrincipal Investigator - University of Pittsburgh Medical Center
University of Pittsburgh
1 Previous Clinical Trials
2,500 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have a machine called ECMO put in your body.
Research Study Groups:
This trial has the following groups:- Group 1: Pilot Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current upper limit of participants for this exploration?
"Affirmative. Clinicaltrial.gov data validates that this scientific research, which was first announced on December 15th 2017, is recruiting participants. Approximately 50 patients must be recruited from 1 medical facility."
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