Incidence and Predictors of Bleeding Diathesis Development Due to DIC in Cirrhosis and ACLF Patients Undergoing CRRT

NCT04960163 | Unknown

• 1 other identifier: ILBS-ACLF-08
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

ACLF and cirrhotic patient have deranged coagulation parameters and this coagulation parameters altered when this group of patients undergoing dialysis because of renal failure. this group of patients is also high risk of sepsis. Most common organ involved during sepsis leading to organ failure is renal. So, all this cascade increases the risk of bleeding as well as coagulation failure. Currently there are no studies evaluation the coagulation status in patients with cirrhosis undergoing dialysis. Further there are no studies evaluating the utility of these global tests of coagulation as a guide to judicious blood transfusion in these patients to prevent bleeding. Further there are no studies comparing the two different modalities of assessment.

Conditions

Acute-On-Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

• Incidence of dialysis related bleeding in first 24 hours

  24 hours

Secondary Outcomes (11)

• To assess correlation of ROTEM abnormalities with risk of clinically significant bleeding

  24 hours

• To assess the volume of FFP pre- and post-procedure

  24 hours

• To assess the volume of Cryoprecipitate pre- and post-procedure

  24 hours

• To assess the volume of platelet pre- and post-procedure

  24 hours

• To assess the volume of packed red blood cell transfusion based on ROTEM pre- and post-procedure

  24 hours

Interventions

No intervention OTHER

No intervention

Also known as: This is an observational Study

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cirrhosis or ACLF undergoing CRRT.

You may qualify if:

• \- Consecutive patients with cirrhosis or ACLF undergoing their first session of dialysis

You may not qualify if:

• Age \<12 or \> 75 years
• Hepatocellular Carcinoma
• Recent history of blood product transfusion in the last 7 days
• History of antiplatelets, antifibrinolytics or antithrombotics
• Active untreated Sepsis/DIC
• Any evidence of active bleed secondary to coagulopathy
• Pregnancy
• Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score \>3, or oxygen/steroid-dependent chronic obstructive pulmonary disease )
• Refusal to participate in the study.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Central Study Contacts

Dr Pinakee Sunder Kar, DM

CONTACT

01146300000; pinakeesunder@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: July 13, 2021
• Study Start: July 15, 2021
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)