Fibtem Predicts Postoperative Bleeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Postoperative Hemorrhage

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No