- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01934907
Transfusion Reaction by Washed Red Blood Cell (RBC)
October 10, 2017 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital
The hypothesis is that transfusion of washed red blood cell can decrease the complication by transfusion.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
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
-
-
Gyeonggi
-
Seongnam, Gyeonggi, Korea, Republic of, 443-607
- 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
20 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: washed RBC
Packed RBCs are Washed and then, transfused.
|
|
|
NO_INTERVENTION: pack RBC
Packed RBCs are transfused.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Complication by transfusion
Time Frame: Operation day and during postoperative 5 days
|
Operation day and during postoperative 5 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total units of RBC transfused.
Time Frame: On the operation day and during the postoperative 5 days
|
On the operation day and during the postoperative 5 days
|
|
Hemoglobin
Time Frame: 1 day before the operation day and postoperative 1 day
|
1 day before the operation day and postoperative 1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (ACTUAL)
August 1, 2013
Primary Completion (ACTUAL)
August 1, 2016
Study Completion (ACTUAL)
August 1, 2016
Study Registration Dates
First Submitted
August 22, 2013
First Submitted That Met QC Criteria
August 29, 2013
First Posted (ESTIMATE)
September 4, 2013
Study Record Updates
Last Update Posted (ACTUAL)
October 11, 2017
Last Update Submitted That Met QC Criteria
October 10, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-1307/212-009
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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