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Comparison of Blood Products Required Using Two Different ROTEM Cut-offs Before Invasive Procedures in Cirrhosis and Acute on Chronic Liver Failure (ACLF) Patients With Severe Coagulopathy

RecruitingNAAges 18 Years - 75 YearsAllInstitute of Liver and Biliary Sciences, India
NCT06831565 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Coagulation system in cirrhotics patients is a fragile state , which is rebalanced hemostasis. Standard tests (INR/aPTT) stop measuring at first stage of coagulation ,when the clot first form. VETs measure the whole process such as ROTEM, TEG and comparing these two tests to assess for transfusion of blood products for invasive procedures. . ROTEM provides information both on anti coagulant and procoagulant status where as conventional tests provide only anti coagulant status Invasive procedures can be low risk or high risk or Non surgical vs surgical, Procedure related bleed occurs in 7% of patients with cirrhosis and associated with higher 28 day mortality. MELD, CTP ,AKI , SEPSIS increase the risk of procedure related bleed. Hence for invasive procedures investigator is using relaxing threshold for blood product transfusion in cirrhosis, ACLF patients. As use of ROTEM when compared to

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Cirrhosis and ACLF ( as per definition) 2. Planned to undergo invasive procedures 3. Severe Coagulopathy- INR\>2.0 or Platelets \<30k or Fibrinogen\<100mg/dl . Exclusion Criteria: 1. Ongoing bleeding 2. Bleeding in past 48 hours before procedure 3. Antiplatelet or anticoagulant therapy ( stopped \< 7 days before)
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What it tests

  • ROTEM
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Where

1 site
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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