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Management of Coagulopathy in Cirrhotic Patients Undergoing Invasive Procedures

NCT02987712 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-12-20

No results posted yet for this study

Summary

Recently it has been acknowledged that cirrhotic patients present with "rebalanced hemostasis" that results from decreased levels of both pro-coagulant and anti-coagulant factors, that is not well reflected by conventional coagulation tests (CCTs). Thromboelastography (TEG) might be a more accurate tool in these patients.

Numerous guidelines on the management of the cirrhotic patient undergoing invasive procedures have been published but most of them are not evidence based. Current literature, although conflicting, is leaning towards a restrictive approach to prophylactic correction of coagulopathy when performing invasive procedures in cirrhotic patients. The investigators suspect that common practice is more liberal . Considering the well-known adverse effects of blood product administration, the aim of the study is to re-evaluate the clinical management of cirrhotic patients undergoing invasive procedures.

Study objectives: asserting whether the use of blood products prior to invasive procedures in cirrhotic coagulopathic patients can be reduced using TEG to evaluate coagulopathy in place of CCTs, evaluating the rate of complications due to blood product use, and checking how well CCT results correlate with TEG results in these patients.

This will be a prospective pre/post TEG protocol implementation study which will include two prospective surveys with a 1:1 ratio. Survey 1: prophylactic administration of FFP/PLT prior to minor invasive procedures will be based on CCTs and physicians' clinical judgement. Survey 2: management will be based on a new TEG protocol. The investigators will include cirrhotic patients with coagulopathy who are candidates for an invasive procedure. Subject will be provided with sufficient time to reach a rational, informed decision regarding participation in the study.

Data will be collected from the computer based medical record systems, the patient file and directly from the caring physician and will include a thorough medical history and conventional blood tests, including a TEG test. All subjects will be managed according to standard of care.

Primary endpoint: amount of blood product (fresh frozen plasma/platelets) units transfused in preparation for the invasive procedures.

Secondary endpoints: bleeding complications, transfusion related side effects, 90 day survival and other complications.

This will be a prospective (pre/post) study. The calculated sample size needed is 120 subjects, 60 in each group.

Conditions

Interventions

OTHER

Thromboelastography based protocol

patients will be treated according to a new thromboelastography based protocol

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Idit Matot, MD, PhD · Tel-Aviv Sourasky Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-12-31
Completion
2018-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02987712 on ClinicalTrials.gov