Liver CirrhosisTIPSprospNCT04421924
Periinterventional Coagulation Management of Patients Undergoing a TIPS
A study testing thrombelastogram in people with Liver Cirrhosis, run by Medical University of Graz at 1 site in Austria.
Trial summary
Assess whether a pre-interventional thrombelastography guided algorithm for assessing and correction of coagulation status in cirrhotic patients is safe and effective Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- thrombelastogram
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteAustria
- Study dates
- 27 May 2020to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Liver cirrhosis
- >18 years
- Indication for TIPS implantation
- Ability to sign informed consent exclusion criteria
- Contraindications against TIPS implantation
- Hepatocellular carcinoma BCLC D
Show all 13Show fewer
- Ongoing bleeding
- pre-existing anticoagulant therapy at time of inclusion
- administration of blood products within 1 week prior to the enrolment
- Other malignancies that lead to an impaired 90-day survival
- Inherit blood clotting disorders
- Hepatic encephalopathy grade 3 or 4
- any other condition or circumstance, which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Department of Internal Medicine, Medical University of Graz
Graz, 8010
Vanessa Stadlbauer, MD, 0043316385 ext. 82282, vanessa.stadlbauer@medunigraz.at
About this study
Official title: Optimizing Periinterventional Coagulation Management of Patients Undergoing a Transjugular Intrahepatic Portosystemic Shunt Implantation: A Prospective Randomized Cohort Study
Assess whether a pre-interventional thrombelastography guided algorithm for assessing and correction of coagulation status in cirrhotic patients is safe and effective
Read the detailed description
Transjugular intrahepatic portosystemic shunt (TIPS) is a very effective procedure to treat complications of portal hypertension in liver cirrhosis. TIPS implantation is indicated in cirrhotic patients to treat or prevent portal hypertensive bleeding and to treat refractory ascites.
During this procedure an artificial connection between portal vein and hepatic vein is placed via an image-guided endovascular approach. Although the procedure is very effective and reasonably safe, several complications can occur.
Due to the underlying cirrhosis, morbidity and mortality of TIPS is high, with a 30-day mortality between 7 and 20%. Procedural site complications (transhepatic and transvenous access), bleeding, development of hepatic encephalopathy or other organ complications and stent complications comprise a considerable risk to the patients, however, the improvement of mortality, renal function and liver function outweighs the risks of the procedure. Optimal patient selection and preoperative preparation is crucial to avoid complications of this procedure.
In liver cirrhosis, coagulation disturbances are common. In hepatic insufficiency, a balanced reduction in the levels of most of pro- and anticoagulant proteins produced in the liver does not impair thrombin generation until levels are quite low. However, the ability of the coagulation system to tolerate or recover from an insult is markedly impaired in liver disease. This allows the coagulation system to be more easily tipped into a state favouring either haemorrhage or thrombosis. The American Gastroenterology Association has recently published best practice advices to manage coagulation in cirrhosis. This review concludes that commonly used global coagulation tests are not optimal to assess the risk of bleeding in cirrhosis. A randomized controlled trial showed, that the use of thrombelastography (TEG) to assess coagulation in cirrhosis resulted in a significantly lower usage of blood products with no increase in bleeding rates.
The bleeding risk for TIPS implantation is not well studied, ranging from 0.6-4.3% of fatal bleeding complications in older uncontrolled case series. No evidenced-based recommendations exist for the correction of coagulation abnormalities before TIPS - and the few existing recommendations are not backed with evidence but rather "eminence based". Currently, global tests of coagulation (prothrombin time and platelet count) are used to guide coagulation correction. Mostly, cut-offs without sufficient evidence (PT >50%/ INR >1.8 and platelets >50 G/L) are used for correction of coagulation.
Also, the risk of stent thrombosis needs to be considered, therefore "blind" substitution of clotting factors or platelet transfusions is not advisable. Unfortunately, the study by De Pietri et al. (6) did only include one patient undergoing TIPS (in the standard of care (SOC) arm), therefore it is yet unknown, whether TEG is useful for guiding the correction of coagulation abnormalities in cirrhosis.
The aim of this trial is to assess, whether TEG guided pre-interventional assessment and correction of coagulation in cirrhotic patients is safe and effective
The study will be performed as a single-center, open-label, randomized prospective cohort study
- Conditions
- Liver Cirrhosis
- Being tested
- thrombelastogram, standard of care
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thrombelastogramProcedure or surgery
Patients in the TEG group will receive prothrombin complex concentrates (PCC) at a dose of 10 IE/kg of ideal body weight, when R-time was greater than 40 minutes (2400 sec) and they will receive platelet transfusion in the amount of 1 apheresis unit when MA was below 30 mm
standard of careProcedure or surgery
- In the SOC group, patients will receive PCC at the dose of 10 IE /kg of ideal body weight when the PT is below 50% and/or INR>1.8 and/or received platelet transfusion in the amount of 1 apheresis when platelet count is below 50 G/L
| Study group | Role | What they receive |
|---|---|---|
| Thrombelastogram (TEG) | Experimental | Patients in the TEG group will receive prothrombin complex concentrates (PCC) at a dose of 10 IE/kg of ideal body weight, when R-time was greater than 40 minutes (2400 sec) and they will receive platelet transfusion in the amount of 1 apheresis unit when MA was below 30 mm. Receives: Procedure: thrombelastogram |
| Standard of Care (SOC) | Experimental | In the SOC group, patients will receive PCC at the dose of 10 IE /kg of ideal body weight when the PT is below 50% and/or INR>1.8 and/or received platelet transfusion in the amount of 1 apheresis when platelet count is below 50 G/L Receives: Procedure: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood product requirement
Amount of blood products (coagulation factors and platelet transfusions) transfused for pre-interventional correction of coagulation status
Measured: 2 days
Secondary outcomes (5)
Bleeding
Rate of bleeding complications (BARC criteria)
Measured: 90 days
complications
Rate of transfusion related complications
Measured: 90 days
Mortality
Mortality rate
Measured: 90 days
Modified TIPS Score (MOTS)
Predictive power of modified TIPS score (MOTS) using the routine parameter, bilirubin, urea and INR; values range from 0-3, high score means worse outcome
Measured: 90 days
Factor XIII
Comparison of measured FXIII activity levels with TEG parameters (alpha-angle, K-time, MA) for assessing feasibility of TEG in predicting deficiency of FXIII activity in these specific group of patients.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start27 May 2020
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
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.
- More trials run by Medical University of GrazThe 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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421924
- Sponsor's protocol ID
- TIPS-prospective
- Acronym
- TIPSprosp
- Status last verified
- Oct 2026
- First submitted
- 4 Jun 2020
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Periinterventional Coagulation Management of Patients Undergoing a Transjugular Intrahepatic Portosystemic Shunt Implantation: A Prospective Randomized Cohort Study
- ClinicalTrials.gov ID
- NCT04421924
- Acronym / sponsor ID
- TIPSprosp / TIPS-prospective
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 9 Jun 2020 (actual)
- 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.
Assess whether a pre-interventional thrombelastography guided algorithm for assessing and correction of coagulation status in cirrhotic patients is safe and effective
Detailed description
Transjugular intrahepatic portosystemic shunt (TIPS) is a very effective procedure to treat complications of portal hypertension in liver cirrhosis. TIPS implantation is indicated in cirrhotic patients to treat or prevent portal hypertensive bleeding and to treat refractory ascites.
During this procedure an artificial connection between portal vein and hepatic vein is placed via an image-guided endovascular approach. Although the procedure is very effective and reasonably safe, several complications can occur.
Due to the underlying cirrhosis, morbidity and mortality of TIPS is high, with a 30-day mortality between 7 and 20%. Procedural site complications (transhepatic and transvenous access), bleeding, development of hepatic encephalopathy or other organ complications and stent complications comprise a considerable risk to the patients, however, the improvement of mortality, renal function and liver function outweighs the risks of the procedure. Optimal patient selection and preoperative preparation is crucial to avoid complications of this procedure.
In liver cirrhosis, coagulation disturbances are common. In hepatic insufficiency, a balanced reduction in the levels of most of pro- and anticoagulant proteins produced in the liver does not impair thrombin generation until levels are quite low. However, the ability of the coagulation system to tolerate or recover from an insult is markedly impaired in liver disease. This allows the coagulation system to be more easily tipped into a state favouring either haemorrhage or thrombosis. The American Gastroenterology Association has recently published best practice advices to manage coagulation in cirrhosis. This review concludes that commonly used global coagulation tests are not optimal to assess the risk of bleeding in cirrhosis. A randomized controlled trial showed, that the use of thrombelastography (TEG) to assess coagulation in cirrhosis resulted in a significantly lower usage of blood products with no increase in bleeding rates.
The bleeding risk for TIPS implantation is not well studied, ranging from 0.6-4.3% of fatal bleeding complications in older uncontrolled case series. No evidenced-based recommendations exist for the correction of coagulation abnormalities before TIPS - and the few existing recommendations are not backed with evidence but rather "eminence based". Currently, global tests of coagulation (prothrombin time and platelet count) are used to guide coagulation correction. Mostly, cut-offs without sufficient evidence (PT >50%/ INR >1.8 and platelets >50 G/L) are used for correction of coagulation.
Also, the risk of stent thrombosis needs to be considered, therefore "blind" substitution of clotting factors or platelet transfusions is not advisable. Unfortunately, the study by De Pietri et al. (6) did only include one patient undergoing TIPS (in the standard of care (SOC) arm), therefore it is yet unknown, whether TEG is useful for guiding the correction of coagulation abnormalities in cirrhosis.
The aim of this trial is to assess, whether TEG guided pre-interventional assessment and correction of coagulation in cirrhotic patients is safe and effective
The study will be performed as a single-center, open-label, randomized prospective cohort study
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrombelastogram (TEG) | Experimental | Procedure: thrombelastogramPatients in the TEG group will receive prothrombin complex concentrates (PCC) at a dose of 10 IE/kg of ideal body weight, when R-time was greater than 40 minutes (2400 sec) and they will receive platelet transfusion in the amount of 1 apheresis unit when MA was below 30 mm. |
| Standard of Care (SOC) | Experimental | Procedure: standard of careIn the SOC group, patients will receive PCC at the dose of 10 IE /kg of ideal body weight when the PT is below 50% and/or INR>1.8 and/or received platelet transfusion in the amount of 1 apheresis when platelet count is below 50 G/L |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Liver cirrhosis
- >18 years
- Indication for TIPS implantation
- Ability to sign informed consent exclusion criteria
- Contraindications against TIPS implantation
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| thrombelastogramPatients in the TEG group will receive prothrombin complex concentrates (PCC) at a dose of 10 IE/kg of ideal body weight, when R-time was greater than 40 minutes (2400 sec) and they will receive platelet transfusion in the amount of 1 apheresis unit when MA was below 30 mm | Procedure or surgery | Thrombelastogram (TEG) |
| standard of care2) In the SOC group, patients will receive PCC at the dose of 10 IE /kg of ideal body weight when the PT is below 50% and/or INR>1.8 and/or received platelet transfusion in the amount of 1 apheresis when platelet count is below 50 G/L | Procedure or surgery | Standard of Care (SOC) |
Primary outcome
blood product requirement
Time frame: 2 days
Amount of blood products (coagulation factors and platelet transfusions) transfused for pre-interventional correction of coagulation status
5 secondary outcomes
Bleeding
Time frame: 90 days
complications
Time frame: 90 days
Mortality
Time frame: 90 days
Modified TIPS Score (MOTS)
Time frame: 90 days
Factor XIII
Time frame: 2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Department of Internal Medicine, Medical University of Graz
Graz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thrombelastogram in people with Liver Cirrhosis, run by Medical University of Graz at 1 site in Austria.
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 13 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood product requirement (time frame: 2 days). 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 13 Oct 2026.