Revision Total Hip Replacement Arthroplasty and Hematologic Variables

October 10, 2017 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital

Relations Between Hematologic Variables and Postoperative Bleeding and Transfusion in Revision Total Hip Replacement Arthroplasty

Revision total hip replacement arthroplasty is a surgery having intra- and postoperative substantial blood loss. The investigators will investigate the relationship between the various hematologic variables and postoperative bleeding volume.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing revision total hip replacement

Description

Inclusion Criteria:

  • revision total hip replacement

Exclusion Criteria:

  • hematologic disease
  • anticoagulant medication
  • American Society of Anesthesiologists physical status 4 and 5

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RTHRA group
patients undergoing revision total hip replacement
Other: RTHRA group
hematologic variables measurement in patients undergoing revision total hip replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of FIBTEM
Time Frame: 5 minutes before initiation of anesthesia and 5 minutes after finishing operation
FIBTEM: one of the measurements of the rotational thromboelastometry
5 minutes before initiation of anesthesia and 5 minutes after finishing operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
volume of infused fluid during operation
Time Frame: Period from starting to finishing the operation (During operation, an expected average of 3 hours)
Infused total crystalloid and colloid volume during the operation will be recorded
Period from starting to finishing the operation (During operation, an expected average of 3 hours)
intraoperative urine output
Time Frame: Period from starting to finishing the operation (During operation, an expected average of 3 hours)
Period from starting to finishing the operation (During operation, an expected average of 3 hours)
transfusion units
Time Frame: Period from starting to finishing the operation (During operation, an expected average of 3 hours) and postoperative first day
Red blood cell
Period from starting to finishing the operation (During operation, an expected average of 3 hours) and postoperative first day
postoperative bleeding volume
Time Frame: postoperative 72 hours
postoperative 72 hours
Hemoglobin
Time Frame: preoperative day 1
preoperative day 1
Hemoglobin
Time Frame: postoperative day 4
postoperative day 4
Hematocrit
Time Frame: preoperative day 1
preoperative day 1
Hematocrit
Time Frame: postoperative day 4
postoperative day 4
Platelet count
Time Frame: preoperative day 1
preoperative day 1
Platelet count
Time Frame: postoperative day 4
postoperative day 4
prothrombin time_international normalized ratio
Time Frame: preoperative day 1
preoperative day 1
prothrombin time_international normalized ratio
Time Frame: postoperative day 1
postoperative day 1
activated partial prothrombin time
Time Frame: preoperative day 1
preoperative day 1
activated partial prothrombin time
Time Frame: postoperative day 1
postoperative day 1
fibrinogen concentration
Time Frame: preoperative day 1
preoperative day 1
fibrinogen concentration
Time Frame: postoperative day 1
postoperative day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Hyo-Seok Na, MD, PhD, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

October 30, 2016

First Posted (Estimate)

November 1, 2016

Study Record Updates

Last Update Posted (Actual)

October 11, 2017

Last Update Submitted That Met QC Criteria

October 10, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1502/288-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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