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NCT02963623 Clinical Trial

Fibtem Predicts Postoperative Bleeding

Postoperative Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02963623
Other study ID # KUH1160104
Secondary ID
Status Completed
Phase N/A
First received November 9, 2016
Last updated March 7, 2018
Start date September 2016
Est. completion date September 2017

Study information
Verified date March 2018
Source Konkuk University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years to 99 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Ka Young Rhee Seoul

Sponsors (1)
Lead Sponsor Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary haemoglobin the decrement of haemoglobin postoperative periods
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