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OpenTrials
Completed

NCT Number: NCT02689232

TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed.

All patients with non variceal bleed who are admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide informed consent.

Completed

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Key information

Conditions

Non Variceal Bleed

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver & Biliary Sciences, New Delhi, National Capital Territory of Delhi, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age more than 18
  • All patient with Non Variceal bleed (INR>1.8 and platelets<50000)
  • Hist logical or imaging proven liver cirrhosis.

Exclusion criteria

  • Variceal Bleed,
  • Pregnancy.,
  • Patients on anticoagulation
  • Patients who refused to participate in the study
  • Post EVL ulcer bleed

Treatment and study plan

fresh frozen plasma

Biological

Platelets Concentrate

Biological

Cryo Precitipitate

Biological

Primary outcomes

  1. Amount of FFP (Fresh Frozen Plasma) transfusion in both groups

    Time frame: 42 days

Secondary outcomes

  1. Number of patients with bleed in both groups

    Time frame: 5 days

  2. Incidence of TRALI (Transfusion associated lung injury) and TACO ( Transfusion associated circulatory overload) in both the groups.

    Time frame: 42 days

  3. Early mortality ( <6 weeks) and late mortality (> 6 weeks) in both the groups.

    Time frame: 42 days

  4. Amount of blood products (Platelet and cryo and Red Blood Cells)transfused in both the groups.

    Time frame: 42 days

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed: An Open Label Randomized Controlled Trial.

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2016
Registry last updated
Nov 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.