Skip to main content
OpenTrials
Completed

NCT Number: NCT02963623

Fibtem Predicts Postoperative Bleeding

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

19 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ka Young Rhee

Seoul, 05030, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. haemoglobin

    Time frame: postoperative periods

    the decrement of haemoglobin

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 15, 2016
Registry last updated
Mar 9, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.