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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02575820
Other study ID # B-1510/318-112
Secondary ID
Status Withdrawn
Phase N/A
First received October 11, 2015
Last updated May 12, 2016
Start date November 2015
Est. completion date May 2016

Study information

Verified date May 2016
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Institutional Review Board: Korea
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Procedure:
Old red blood cells transfusion
Red blood cells (shelf life > 14 days) transfusion during the operation (total hip replacement arthroplasty)
New red blood cells transfusion
Red blood cells (shelf life =< 14 days) transfusion during the operation (total hip replacement arthroplasty)

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnamsi

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality postoperative 7 days No
Primary Sepsis postoperative 7 days No
Primary Wound infection postoperative 7 days No
Primary Postoperative delirium postoperative 7 days No
Primary Postoperative bleeding postoperative 7 days No
Secondary Transfusion related lung injury postoperative 7 days No
Secondary Pulmonary edema postoperative 7 days No
Secondary Pulmonary effusion postoperative 7 days No
Secondary Myocardial ischemia postoperative 7 days No
Secondary Pulmonary thromboembolism postoperative 7 days No
Secondary Renal failure postoperative 7 days No
Secondary Hepatic failure postoperative 7 days No
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