Fibtem Predicts Postoperative Bleeding

March 7, 2018 updated by: Ka Young Rhee, Konkuk University Medical Center

The Prediction of Postoperative Hemorrahge Amount in Total Knee Replacement Using Fibtem

Retrospective study to evaluate if FIBTEM predicts the amount of postoperative bleeding in total knee replacement patients.

Study Overview

Status

Completed

Conditions

Detailed Description

This retrospective study evaluate patients who underwent total knee replacement arthroplasty. Laboratory coagulation parameters, including FIBTEM, before anesthesia induction and after admission to the post-anesthetic care unit and decrement of postoperative haemoglobin and amount of transfusion were reviewed.

A correlation coefficient of ρ = 0.4 was calculated from a pilot study. We need at least 44 subjects with an α value of 0.05 and a power of 0.8.

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

total knee replacement patients

Description

Inclusion Criteria:

  • patients who underwent primany unilateral total knee replacement arthroplasty under general anesthesia
  • patients who had FIBTEM performed

Exclusion Criteria:

  • surgery under regional anaesthesia
  • a simultaneous bilateral total knee replacement arthroplasty
  • the second surgery of staged total knee replacement arthroplasty
  • revision of total knee replacement arthroplasty
  • patients who received intraoperative transfusion
  • patients who use tranexamic acid
  • patients who received fibrinolytic agents because of perioperative thromboembolic event
  • patients who refused transfusion because of religious belief of personal causes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
haemoglobin
Time Frame: postoperative periods
the decrement of haemoglobin
postoperative periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konkuk University Medical Center

Investigators

  • Principal Investigator: Ka Young LRhee, Konkuk University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

November 9, 2016

First Submitted That Met QC Criteria

November 10, 2016

First Posted (Estimate)

November 15, 2016

Study Record Updates

Last Update Posted (Actual)

March 9, 2018

Last Update Submitted That Met QC Criteria

March 7, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH1160104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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