Fibtem Predicts Postoperative Bleeding

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02963623

Enrollment

Registered

2016-11-15

Start date

2016-09-30

Completion date

2017-09-30

Last updated

2018-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Hemorrhage

Keywords

fibtem, total knee replacement

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
haemoglobin	postoperative periods	the decrement of haemoglobin

Countries

South Korea

Outcome results