- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04960163
Incidence and Predictors of Bleeding Diathesis Development Due to DIC in Cirrhosis and ACLF Patients Undergoing CRRT
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
METHODOLOGY Aim: The incidence and predictors of bleeding diathesis development due to DIC in cirrhosis and ACLF patients undergoing CRRT
Primary Objective:
Primary: Development of bleeding diathesis within 3 days [ e.g-bleeding/ooze from access sites, GI bleeding (blood in ryles tube, hematemesis's, melena, bleeding PR), bleed form ET tube site, bleed form nose/mouth or any other site]
Secondary Objective:
Assess the following factors as predictors of bleeding diathesis within 3 days:
- Severity of liver disease: CTP, MELD, MELD-Na, APACHE, SOFA, AARC, lactate, ammonia, [baseline and degree of change ,12 hrly,24 ,48 and 72 Hrly]
- Presence and severity of AKI, HE [baseline and degree of change 12 hrly,24,48,72 or at the detection of bleeding]
- Presence and severity of infections/sepsis [baseline and degree of change 12 hrly or at the detection of bleeding]
- Complement levels (C3/C4) [baseline and degree of change at day 3 or at the detection of bleeding]
- Following test of coagulation system [baseline and degree of change 12 hrly,24,48,72 hrly and at the detection of bleeding [ Platelets counts (manual), PT(INR), Prothrombin index, aPTT, Factor VIII/vWF , Fibrinogen, d-Dimer, FDP, DIC score)
- ROTEM (EXTEM,FIBTEM,APTEM,INTEM)
- Type and dose vasopressors (NA, vaso, Terlipressin, somat, phenylep)
- Hemodynamic parameters [pulse, BP, Lung water, SVV, SVR, CO/CI] optional
- CRRT parameters [type of dialysate, membrane, flow,]
- Survival by day 7
Study Population: Patients with cirrhosis or ACLF undergoing CRRT.
Study Design: A prospective study.
Study Period
- The study will be conducted on patients admitted to Department of Hepatology from May 2021 to Aug 2021 at ILBS, New Delhi
- Study group will comprise of patients with cirrhosis undergoing dialysis.
Sample size with Justification: There are no previous study to determine the bleeding risk in ACLF or cirrhotic patient undergoing CRRT therapy so this is the pilot study so taking first 40 patients.
Intervention: There are no intervention arm. its prospective trial.
Monitoring and assessment: Investigator will be monitoring any bleeding epiosdes during the CRRT and in case there are any bleeding risk the coagulation factors based upon ROTEM and correct the coagulation abnormalties will be done.
Statistical Analysis:
- All variables shall be expressed in median (range)
- Variables will be compared by Mann- Whitney U test
- For Categorical variables we will use Chi-Square or Fisher's test
- Survival analysis will be done using cox-proportional regression analysis
Actuarial probability of survival shall be calculated by Kaplan- Meier graph and compared by log- rank test.
Adverse Effects: increase risk of bleeding during CRRT
Stopping rule of Study: in case of bleeding not controlled with coagulation correction or patient become hemodynamically unstable , negative consent for the further course of treatment then study will be stopped .
Expected outcome of the project-.
Primary end points:
Incidence of dialysis related bleeding in first 24 hours
Secondary end points:
- To assess correlation of ROTEM abnormalities with risk of clinically significant bleeding
- To assess the need and volume of FFP, Cryoprecipitate, platelet and packed red blood cell transfusion based on ROTEM pre- and post-procedure
- Incidence of transfusion associated lung injury and circulatory overload in both groups at 24 hours
- Incidence of infections (Time frame first 24 hours)
- Incidence of infections and bleeding in first 7 days
- Duration of hospital or ICU stay in both groups
- 7 day mortality.
ROTEM would be done pre-procedure to assess the coagulation status for all patients enrolled and subsequently post procedure and in case of bleeding, after transfusion at 12 hours and 24 hours, 48 and 72 hours respectively. Other standard blood tests would be done including record of mean arterial pressures, CBC, KFT, LFT, PT/INR, arterial ammonia, lactate, serum procalcitonin as required. In case of presence or absence of active bleed FFPs, Cryoprecipitate, platelets will be transfused depending upon the coagulation parameters as assessed by ROTEM .
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Dr Pinakee Sunder Kar, DM
- Phone Number: 01146300000
- Email: pinakeesunder@gmail.com
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110070
- Institute of Liver & Biliary Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Consecutive patients with cirrhosis or ACLF undergoing their first session of dialysis
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of dialysis related bleeding in first 24 hours
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess correlation of ROTEM abnormalities with risk of clinically significant bleeding
Time Frame: 24 hours
|
24 hours
|
To assess the volume of FFP pre- and post-procedure
Time Frame: 24 hours
|
24 hours
|
To assess the volume of Cryoprecipitate pre- and post-procedure
Time Frame: 24 hours
|
24 hours
|
To assess the volume of platelet pre- and post-procedure
Time Frame: 24 hours
|
24 hours
|
To assess the volume of packed red blood cell transfusion based on ROTEM pre- and post-procedure
Time Frame: 24 hours
|
24 hours
|
Incidence of transfusion associated lung injury and circulatory overload in both groups at 24 hours
Time Frame: 24 hours
|
24 hours
|
Incidence of infections
Time Frame: 24 hours
|
24 hours
|
Incidence of infections
Time Frame: 7 days
|
7 days
|
Incidence of bleeding
Time Frame: 7 days
|
7 days
|
Duration of Intensive Care Unit or hospital
Time Frame: 7 days
|
7 days
|
Mortality
Time Frame: 7 days
|
7 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ILBS-ACLF-08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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