Back to resultsTransfusion Reaction by Washed Red Blood Cell (RBC)
Primary Purpose
Orthopedic Disorder
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Washing of packed RBC by normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Orthopedic Disorder
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing total hip replacement arthroplasty
Exclusion Criteria:
- Patients who do not agree with this clinical study.
- Patients who have a history of transfusion for recent 1 month.
- Patients who have rare blood types.
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
washed RBC
pack RBC
Arm Description
Packed RBCs are Washed and then, transfused.
Packed RBCs are transfused.
Outcomes
Primary Outcome Measures
Complication by transfusion
Secondary Outcome Measures
Total units of RBC transfused.
Hemoglobin
Full Information
NCT ID
NCT01934907
First Posted
August 22, 2013
Last Updated
October 10, 2017
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01934907
Brief Title
Transfusion Reaction by Washed Red Blood Cell (RBC)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The hypothesis is that transfusion of washed red blood cell can decrease the complication by transfusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
washed RBC
Arm Type
Experimental
Arm Description
Packed RBCs are Washed and then, transfused.
Arm Title
pack RBC
Arm Type
No Intervention
Arm Description
Packed RBCs are transfused.
Intervention Type
Other
Intervention Name(s)
Washing of packed RBC by normal saline
Primary Outcome Measure Information:
Title
Complication by transfusion
Time Frame
Operation day and during postoperative 5 days
Secondary Outcome Measure Information:
Title
Total units of RBC transfused.
Time Frame
On the operation day and during the postoperative 5 days
Title
Hemoglobin
Time Frame
1 day before the operation day and postoperative 1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing total hip replacement arthroplasty
Exclusion Criteria:
Patients who do not agree with this clinical study.
Patients who have a history of transfusion for recent 1 month.
Patients who have rare blood types.
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
443-607
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Transfusion Reaction by Washed Red Blood Cell (RBC)
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