Old Blood and Postoperative Complications

May 12, 2016 updated by: Hyun-Jung Shin, Seoul National University Hospital

The Effects of Old Red Blood Cell Transfusion on Morbidity in Patients Undergoing Revision Total Hip Arthroplasty: Retrospective Study

The investigators sought to examine the effects of 'old' red blood cells on mortality and morbidity of patients who undergoing revision hip replacement arthroplasty. The investigators hypothesis is that patients have an increased risk of mortality and infection after 'old' red blood cells transfusions compared with those who received 'new' transfusions.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

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
      • Seongnamsi, 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent revision total hip replacement

Description

Inclusion Criteria:

  • Patients who underwent revision total hip replacement

Exclusion Criteria:

  • Patients who were not given red blood cells
  • Patients who were given two units of which one unit was old and one was new

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RBC_old
shelf life of red blood cells of 15 or higher days
Procedure: Old red blood cells transfusion
Red blood cells (shelf life > 14 days) transfusion during the operation (total hip replacement arthroplasty)
RBC_new
shelf life of red blood cells 14 or lower days
Procedure: New red blood cells transfusion
Red blood cells (shelf life =< 14 days) transfusion during the operation (total hip replacement arthroplasty)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: postoperative 7 days
postoperative 7 days
Sepsis
Time Frame: postoperative 7 days
postoperative 7 days
Wound infection
Time Frame: postoperative 7 days
postoperative 7 days
Postoperative delirium
Time Frame: postoperative 7 days
postoperative 7 days
Postoperative bleeding
Time Frame: postoperative 7 days
postoperative 7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Transfusion related lung injury
Time Frame: postoperative 7 days
postoperative 7 days
Pulmonary edema
Time Frame: postoperative 7 days
postoperative 7 days
Pulmonary effusion
Time Frame: postoperative 7 days
postoperative 7 days
Myocardial ischemia
Time Frame: postoperative 7 days
postoperative 7 days
Pulmonary thromboembolism
Time Frame: postoperative 7 days
postoperative 7 days
Renal failure
Time Frame: postoperative 7 days
postoperative 7 days
Hepatic failure
Time Frame: postoperative 7 days
postoperative 7 days

Collaborators and Investigators

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

Sponsor

Seoul National University 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

November 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

October 11, 2015

First Submitted That Met QC Criteria

October 14, 2015

First Posted (Estimate)

October 15, 2015

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1510/318-112

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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