Rotational Thromboelastometry [ROTEM] vs Thromboelastography [TEG] Guided Blood Component Use in Patients With Cirrhosis of Liver With Non-variceal Bleeding.

AIM:- To compare Rotational thrombo- elastometry vs Thrombo- elastography as a guide for blood component transfusion in patients of Cirrhosis with nonvariceal bleeding.

Methodology:- After fulfilling all inclusion and exclusion criteria, patients were randomized to either the TEG or ROTEM group in a 1:1 proportion. Patients in the TEG group received blood components using the following triggers: FFP at a dose of 10 mL/kg of ideal body weight when reaction time (R time) was greater than 10 minutes; a single-donor apheresis platelet (SDAP) unit, which corresponds to approximately 6 to 8 pooled units of PLTs, transfused when the maximum amplitude (MA) was less than 55 mm; and cryoprecipitate (5 pooled units) transfused when the alpha angle was less than 45°.In ROTEM group if CT EXTEM >80S FFP at dose of 10ml/kg or PCC 20-25IU/kg ,if MCF EXTEM <35 and MCF FIBTEM <8 CRYO or Fibrinogen concentrate, if MCF EXTEM<35 and MCF FIBTEM >8 Platelet, CL LY>50 Trenaxemic acid

Study population: patients with Cirrhosis of liver with nonvariceal bleeding Study design: Randomized controlled trial Study period: 1 years after ethical clearance

Sample size: Assuming that total volume of FFP used in TEG 760 ± 370 and further in ROTEM volume used 510±275 with α 5% power 90, we need to enrol 72 cases. Further assuming 10% inadequacy We had decided to enroll a total of 80 patients, 40 in each group.The allocation will be done randomly by block randomization method.

Monitoring and assessment: All the parameters of the objective and also noted any adverse effects.

STATISTICAL ANALYSIS:

The data will be entered in Microsoft excel and will be analyzed using SPSS version 22. The categorical data will be analyzed using Chi square/Fissure test. Exact test and continuous data will be compiled using t-test. Besides this the univariate and multivariate survival analysis will be carried out using Cox regression method. Kaplan-Meier technique will be applied for further analysis. P-value<0.05 will be considered as significant.

Adverse effects:Transfusion related complication

Stopping rule: If patient decided to withdraw from study

Inclusion criteria

• Patients with Cirrhosis of any etiology
• Age between 18 and 80 years;
• Presenting with nonvariceal upper GI bleeding (diagnosed after doing upper GI endoscopy, which showed ongoing
• bleed form a nonvariceal source); and
• Significant coagulopathy assessed by CCTs (INR > 1.8 and/or PLTs < 50 × 109/L).

Exclusion criteria

• Variceal bleed
• Post Variceal ligation ulcer bleed
• Previous or current thrombotic events defined as any documented blood clot in a venous or arterial vessel;
• Anti-PLT or anticoagulant therapy at the time of enrollment or that had been discontinued less than 7 days before evaluation for the study;
• Pregnancy
• Significant cardiopulmonary diseases.