NCT02963623

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

November 9, 2016

Last Update Submit

March 7, 2018

Conditions

Postoperative Hemorrhage

Keywords

fibtemtotal knee replacement

Outcome Measures

Primary Outcomes (1)

  • haemoglobin

    the decrement of haemoglobin

    postoperative periods

Eligibility Criteria

Age19 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

total knee replacement patients

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ka Young Rhee

Seoul, 05030, South Korea

Location

MeSH Terms

Conditions

Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Study Officials

  • Ka Young LRhee

    Konkuk University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 9, 2016

First Posted

November 15, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

March 9, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will share

Locations

KR(1)