Liver CirrhosisPhase 2NCT02362178
Thromboelastographic Guide for Blood Products in Cirrhotics
A Phase 2 study testing Thromboelastography to guide blood products infusion in people with Liver Cirrhosis and Coagulation Disorder, run by University of Modena and Reggio Emilia.
Trial summary
Blood products are commonly used before invasive procedures in patients with end-stage liver diseases despite cirrhosis being a thrombophylic state. Traditional coagulation tests (namely INR and PLTs count) are known to be unreliable in predicting bleeding risk before invasive procedures and in representing the real… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis, Coagulation Disorder
- What is being tested?
- Thromboelastography to guide blood products infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Sep 2014
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic or imaging-proven liver cirrhosis of any etiology
- INR>1.8 and/or PLTs count <50x103/μl
Who cannot join
- Ongoing bleeding
- Previous or current thrombotic events defined as any documented blood clot in a venous or arterial vessel
- Ongoing antiplatelet or anticoagulant therapy or stopped less than 7 days before evaluation for the study
- Presence of sepsis according to ACP-SCCP criteria
- Hemodialysis performed within 7 days
About this study
Official title: USE OF THROMBOELASTOGRAPHY TO GUIDE BLOOD PRODUCTS REPLACEMENT IN DECOMPENSATED CIRRHOTIC PATIENTS UNDERGOING INVASIVE PROCEDURES
Blood products are commonly used before invasive procedures in patients with end-stage liver diseases despite cirrhosis being a thrombophylic state. Traditional coagulation tests (namely INR and PLTs count) are known to be unreliable in predicting bleeding risk before invasive procedures and in representing the real coagulation status of cirrhotic patients. Notwithstanding they are still used to guide blood products administration before invasive procedures. Thromboelastography (TEG) has been shown to be effective in detecting signs of hypo-hypercoagulability possibly being an alternative method to guide blood products transfusion. The aim of this randomized controlled study was to evaluate the efficacy of TEG as a guide for blood products transfusion in cirrhotic patients undergoing invasive procedures.
- Conditions
- Liver Cirrhosis, Coagulation Disorder
- Being tested
- Thromboelastography to guide blood products infusion, Standard of care coagulation tests to guide blood products infusion
- Medical subject headings
- Liver Cirrhosis, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thromboelastography to guide blood products infusionProcedure or surgery
A TEG has been performed before invasive procedure and blood products infusion has been decided according to TEG parameters as follow: fresh frozen plasma (FFP 10 ml/kg) in case of r time>40 mm and/or platelets (PLTs 10 units/Kg) for MA<30 mm
Standard of care coagulation tests to guide blood products infusionProcedure or surgery
Patients received FFP (10 ml/kg) if INR>1.8 and/or PLTS (10 units/Kg) If PLTs count < 50000/μl
| Study group | Role | What they receive |
|---|---|---|
| Thromboelastography (TEG) | Experimental | Patients in the TEG group received fresh frozen plasma at the dose of 10 ml/kg of ideal body weight, only if INR was higher than 1.8 and r time longer than 40 minutes. They received platelets at the amount of 1 apheresis Unit, only if platelets count was lower than 50000/μl and MA was shorter than 30 millimeter. Receives: Procedure: Thromboelastography to guide blood products infusion |
| Standard of Care (SOC) | Active comparator | In the SOC group patients received fresh frozen plasma at the dose of 10 ml/kg of ideal body weight, when INR was higher than 1.8. They received platelets at the amount of 1 apheresis Unit, when platelets count was lower than 50000/μl. Receives: Procedure: Standard of care coagulation tests to guide blood products infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison in the amount of blood products transfused between the groups
Comparison of the number of patients receiving blood products (FFPor PLTs or both), and the amount of blood products between the study groups
Measured: 48 hours from admission
Secondary outcomes (5)
Post-procedure bleeding
Comparison of the number of patients having bleeding episodes after procedure between the study groups
Measured: 48 hours from admission
Survival
Comparison of patients survival between the study groups
Measured: 90 days patient survival
Transfusion related side effects
Comparison of the number of patients presenting transfusion side effects between the study groups
Measured: 48 hours from admission
Procedure-related complications
Comparison of the number of patients presenting post-procedures complication other than bleeding between the study groups
Measured: during hospitalization (mean 4 weeks)
Comparison between blood products costs between groups
Measured: 48 hours from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startFeb 2011
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lesley De Pietri, University of Modena and Reggio Emilia
- Investigators
- Lesley De pietri, MD, Principal investigator, Azienda Ospedaliero-Universitaria di Modena-Policlinico, Division of Anaesthesiology and Intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362178
- Sponsor's protocol ID
- 133/10
- Status last verified
- Feb 2015
- First submitted
- 23 Jan 2015
- Last updated
- 12 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- USE OF THROMBOELASTOGRAPHY TO GUIDE BLOOD PRODUCTS REPLACEMENT IN DECOMPENSATED CIRRHOTIC PATIENTS UNDERGOING INVASIVE PROCEDURES
- ClinicalTrials.gov ID
- NCT02362178
- Acronym / sponsor ID
- 133/10
- Conditions
- Liver Cirrhosis, Coagulation Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Feb 2015 (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.
Blood products are commonly used before invasive procedures in patients with end-stage liver diseases despite cirrhosis being a thrombophylic state. Traditional coagulation tests (namely INR and PLTs count) are known to be unreliable in predicting bleeding risk before invasive procedures and in representing the real coagulation status of cirrhotic patients. Notwithstanding they are still used to guide blood products administration before invasive procedures. Thromboelastography (TEG) has been shown to be effective in detecting signs of hypo-hypercoagulability possibly being an alternative method to guide blood products transfusion. The aim of this randomized controlled study was to evaluate the efficacy of TEG as a guide for blood products transfusion in cirrhotic patients undergoing invasive procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thromboelastography (TEG) | Experimental | Procedure: Thromboelastography to guide blood products infusionPatients in the TEG group received fresh frozen plasma at the dose of 10 ml/kg of ideal body weight, only if INR was higher than 1.8 and r time longer than 40 minutes. They received platelets at the amount of 1 apheresis Unit, only if platelets count was lower than 50000/μl and MA was shorter than 30 millimeter. |
| Standard of Care (SOC) | Active comparator | Procedure: Standard of care coagulation tests to guide blood products infusionIn the SOC group patients received fresh frozen plasma at the dose of 10 ml/kg of ideal body weight, when INR was higher than 1.8. They received platelets at the amount of 1 apheresis Unit, when platelets count was lower than 50000/μl. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologic or imaging-proven liver cirrhosis of any etiology
- INR>1.8 and/or PLTs count <50x103/μl
Key exclusion criteria (5 listed)
- Ongoing bleeding
- Previous or current thrombotic events defined as any documented blood clot in a venous or arterial vessel
- Ongoing antiplatelet or anticoagulant therapy or stopped less than 7 days before evaluation for the study
- Presence of sepsis according to ACP-SCCP criteria
- Hemodialysis performed within 7 days
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 |
|---|---|---|
| Thromboelastography to guide blood products infusionA TEG has been performed before invasive procedure and blood products infusion has been decided according to TEG parameters as follow: fresh frozen plasma (FFP 10 ml/kg) in case of r time>40 mm and/or platelets (PLTs 10 units/Kg) for MA<30 mm | Procedure or surgery | Thromboelastography (TEG) |
| Standard of care coagulation tests to guide blood products infusionPatients received FFP (10 ml/kg) if INR>1.8 and/or PLTS (10 units/Kg) If PLTs count < 50000/μl | Procedure or surgery | Standard of Care (SOC) |
Primary outcome
Comparison in the amount of blood products transfused between the groups
Time frame: 48 hours from admission
Comparison of the number of patients receiving blood products (FFPor PLTs or both), and the amount of blood products between the study groups
5 secondary outcomes
Post-procedure bleeding
Time frame: 48 hours from admission
Survival
Time frame: 90 days patient survival
Transfusion related side effects
Time frame: 48 hours from admission
Procedure-related complications
Time frame: during hospitalization (mean 4 weeks)
Comparison between blood products costs between groups
Time frame: 48 hours from admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.
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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.
Lesley De pietri, MD principal investigator
Azienda Ospedaliero-Universitaria di Modena-Policlinico, Division of Anaesthesiology and Intensive Care Unit
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thromboelastography to guide blood products infusion in people with Liver Cirrhosis and Coagulation Disorder, run by University of Modena and Reggio Emilia.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 12 Feb 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison in the amount of blood products transfused between the groups (time frame: 48 hours from admission). 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 12 Feb 2015.