Transfusion Reaction by Washed Red Blood Cell (RBC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Seoul National University Bundang Hospital
Sponsor:
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01934907
First received: August 22, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

The hypothesis is that transfusion of washed red blood cell can decrease the complication by transfusion.


Condition Intervention
Avascular Necrosis of Hip.
Degenerative Arthritis, Hip.
Osteoarthritis, Hip.
Developmental Dislocation of Hip.
Dysplastic Hip.
Other: Washing of packed RBC by normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Complication by transfusion [ Time Frame: Operation day and during postoperative 5 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Total units of RBC transfused. [ Time Frame: On the operation day and during the postoperative 5 days ] [ Designated as safety issue: No ]
  • Hemoglobin [ Time Frame: 1 day before the operation day and postoperative 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 223
Study Start Date: August 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: washed RBC
Packed RBCs are Washed and then, transfused.
Other: Washing of packed RBC by normal saline
No Intervention: pack RBC
Packed RBCs are transfused.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01934907

Contacts
Contact: Hyo-Seok Na, PhD. 82 31 787 7507 hsknana@gmail.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of, 443-607
Contact: Hyo-Seok Na    82 31 787 7507    hsknana@gmail.com   
Principal Investigator: Hyo-Seok Na         
Sponsors and Collaborators
Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Hyo-Seok Na, Dr., Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01934907     History of Changes
Other Study ID Numbers: B-1307/212-009
Study First Received: August 22, 2013
Last Updated: May 27, 2014
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Dislocations
Hip Dislocation
Hip Dislocation, Congenital
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 22, 2014