Old Blood and Postoperative Complications

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02575820
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Duration (Months): 6
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Orthopedics; Postoperative Complications; Red Blood Cells	Procedure: Old red blood cells transfusion; Procedure: New red blood cells transfusion

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: The Effects of Old Red Blood Cell Transfusion on Morbidity in Patients Undergoing Revision Total Hip Arthroplasty: Retrospective Study
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

1. Mortality [postoperative 7 days]

2. Sepsis [postoperative 7 days]

3. Wound infection [postoperative 7 days]

4. Postoperative delirium [postoperative 7 days]

5. Postoperative bleeding [postoperative 7 days]

Secondary Outcome Measures

1. Transfusion related lung injury [postoperative 7 days]

2. Pulmonary edema [postoperative 7 days]

3. Pulmonary effusion [postoperative 7 days]

4. Myocardial ischemia [postoperative 7 days]

5. Pulmonary thromboembolism [postoperative 7 days]

6. Renal failure [postoperative 7 days]

7. Hepatic failure [postoperative 7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnamsi		Korea, Republic of	13620

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hyun-Jung Shin, Assistant Professor, Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT02575820
• Other Study ID Numbers: B-1510/318-112
• First Posted: Oct 15, 2015
• Last Update Posted: May 13, 2016
• Last Verified: May 1, 2016

• Additional relevant MeSH terms: Postoperative Complications

Study Results

No Results Posted as of May 13, 2016