NCT02575820

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

October 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

October 11, 2015

Last Update Submit

May 12, 2016

Conditions

OrthopedicsPostoperative ComplicationsRed Blood Cells

Outcome Measures

Primary Outcomes (5)

  • Mortality

    postoperative 7 days

  • Sepsis

    postoperative 7 days

  • Wound infection

    postoperative 7 days

  • Postoperative delirium

    postoperative 7 days

  • Postoperative bleeding

    postoperative 7 days

Secondary Outcomes (7)

  • Transfusion related lung injury

    postoperative 7 days

  • Pulmonary edema

    postoperative 7 days

  • Pulmonary effusion

    postoperative 7 days

  • Myocardial ischemia

    postoperative 7 days

  • Pulmonary thromboembolism

    postoperative 7 days

  • +2 more secondary outcomes

Study Arms (2)

RBC_old

shelf life of red blood cells of 15 or higher days

Procedure: Old red blood cells transfusion

RBC_new

shelf life of red blood cells 14 or lower days

Procedure: New red blood cells transfusion

Interventions

Old red blood cells transfusionPROCEDURE

Red blood cells (shelf life \> 14 days) transfusion during the operation (total hip replacement arthroplasty)

RBC_old
New red blood cells transfusionPROCEDURE

Red blood cells (shelf life =\< 14 days) transfusion during the operation (total hip replacement arthroplasty)

RBC_new

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent revision total hip replacement

You may qualify if:

  • Patients who underwent revision total hip replacement

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

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

Study Record Dates

First Submitted

October 11, 2015

First Posted

October 15, 2015

Study Start

November 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations

KR(1)