THRA_hematologic Variables

August 28, 2013 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital

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

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

Study Type

Observational

Enrollment (Actual)

73

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
    • Gyounggi
      • Seongnam, Gyounggi, Korea, Republic of, 463-707
        • 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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients diagosed with avascular necrosis of hip and undergoing total hip replacement arthroplasty

Description

Inclusion Criteria:

  • avascular necrosis of hip
  • total hip replacement arthroplasty

Exclusion Criteria:

  • revision operation
  • hematologic disease
  • anticoagulant medication
  • preoperative hemoglobin < 10 g/dl
  • preoperative transfusion of red blood cells

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative bleeding volume
Time Frame: at first postoperative day
at first postoperative day
Hemoglobin
Time Frame: preoperative 1 day and postoperative 1 day
preoperative 1 day and postoperative 1 day
hematocrit
Time Frame: preoperative 1 day and postoperative 1 day
preoperative 1 day and postoperative 1 day
platelet
Time Frame: preoperative 1 day and postoperative 1 day
preoperative 1 day and postoperative 1 day
prothrombin time_international normalized ratio
Time Frame: preoperative 1 day and postoperative 1 day
preoperative 1 day and postoperative 1 day
activated partial prothrombin time
Time Frame: preoperative 1 day and postoperative 1 day
preoperative 1 day and postoperative 1 day
fibrinogen concentration
Time Frame: preoperative 1 day and postoperative 1 day
preoperative 1 day and postoperative 1 day
Rotational thromboelastometry
Time Frame: preoperative 1 day and postoperative 1 day
preoperative 1 day and postoperative 1 day

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 operaiton, 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 operaiton, an expected average of 3 hours)
intraoperative urine output
Time Frame: Period from starting to finishing the operation (During operaiton, an expected average of 3 hours)
Period from starting to finishing the operation (During operaiton, an expected average of 3 hours)
transfusion units
Time Frame: Period from starting to finishing the operation (During operaiton, an expected average of 3 hours) and postoperative first day
Red blood cell
Period from starting to finishing the operation (During operaiton, an expected average of 3 hours) and postoperative first day

Collaborators and Investigators

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

Sponsor

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

January 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

January 26, 2012

First Posted (Estimate)

January 31, 2012

Study Record Updates

Last Update Posted (Estimate)

August 29, 2013

Last Update Submitted That Met QC Criteria

August 28, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B_1111_140_103

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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