NCT01934907

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

3 years

First QC Date

August 22, 2013

Last Update Submit

October 10, 2017

Conditions

Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

  • Complication by transfusion

    Operation day and during postoperative 5 days

Secondary Outcomes (2)

  • Total units of RBC transfused.

    On the operation day and during the postoperative 5 days

  • Hemoglobin

    1 day before the operation day and postoperative 1 day

Study Arms (2)

washed RBC

EXPERIMENTAL

Packed RBCs are Washed and then, transfused.

Other: Washing of packed RBC by normal saline

pack RBC

NO INTERVENTION

Packed RBCs are transfused.

Interventions

Washing of packed RBC by normal salineOTHER
washed RBC

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing total hip replacement arthroplasty

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 443-607, South Korea

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 22, 2013

First Posted

September 4, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

October 11, 2017

Record last verified: 2017-10

Locations

KR(1)