Cirrhosis, CoagulopathyNCT02990273
The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures
A study testing Blood transfusion in people with Cirrhosis, Coagulopathy, run by Johns Hopkins University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Coagulopathy
- What is being tested?
- Blood transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to 19 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All 18 yo + cirrhotic patients who are being scheduled for inpatient endoscopy
Who cannot join
- 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
About this study
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.
- Conditions
- Cirrhosis, Coagulopathy
- Being tested
- Blood transfusion
- Medical subject headings
- Fibrosis, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood transfusionBiological
| Study group | Role | What they receive |
|---|---|---|
| TEG | Active comparator | Blood transfusion Receives: Biological: Blood transfusion |
| Prothrombin Time (PT)/International normalized ratio (INR) | Active comparator | Blood transfusion Receives: Biological: Blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Units of fresh frozen plasma (FFP) and platelet transfused
Will compare how much FFP and platelet transfusion patients receiving between 2 groups.
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startJan 2017
- Primary completion19 Jan 2021
- Study completion19 Jan 2021
Why it stopped: No funding source available which was required for IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, CoagulopathyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tinsay Woreta, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990273
- Sponsor's protocol ID
- IRB00113092
- Status last verified
- Jan 2021
- First submitted
- 14 Oct 2016
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures
- ClinicalTrials.gov ID
- NCT02990273
- Acronym / sponsor ID
- IRB00113092
- Conditions
- Cirrhosis, Coagulopathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No funding source available which was required for IRB approval
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 19 Jan 2021 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEG | Active comparator | Biological: Blood transfusionBlood transfusion |
| Prothrombin Time (PT)/International normalized ratio (INR) | Active comparator | Biological: Blood transfusionBlood transfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All 18 yo + cirrhotic patients who are being scheduled for inpatient endoscopy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood transfusion | Biological | Prothrombin Time (PT)/International normalized ratio (INR), TEG |
Primary outcome
Units of fresh frozen plasma (FFP) and platelet transfused
Time frame: 2 week
Will compare how much FFP and platelet transfusion patients receiving between 2 groups.
Results and safety
The study was stopped early (reason given: No funding source available which was required for IRB approval). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tinsay Woreta principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Blood transfusion in people with Cirrhosis, Coagulopathy, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No funding source available which was required for IRB approval). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Units of fresh frozen plasma (FFP) and platelet transfused (time frame: 2 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.