NCT03282201

Brief Summary

The rate of hip, knee arthroplasties and their revision are increasing every year. The incidence of blood transfusion in these operations are reported 18%, 68%, and 39%, 67%, respectively. Blood transfusion is known to increase the risk of pulmonary, septic, wound and thromboembolic complications and is related to mortality. Restrictive transfusion protocols has cost-effective results in terms of reducing these complications, promoting early discharge and reduced frequency of re-admission. Within this context, we aimed to evaluate the transfusion practice in our hospital, define the transfusion indicators and compare the transfused and non transfused patients in terms of recovery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
418

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

September 12, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 15, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2018

Completed
Last Updated

November 2, 2018

Status Verified

September 1, 2017

Enrollment Period

7 months

First QC Date

September 12, 2017

Last Update Submit

November 1, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Discharge time

    Discharge time from hospital

    Postoperative day 1-6 days

  • TUG test

    Walking without help

    Postoperative day 1-2

Study Arms (2)

Transfused

Patients in whom blood transfusion is used

Other: Transfusion

Nontransfused

Patients in whom blood transfusion is not used

Interventions

Transfusion of red blood cells, fresh frozen plasma, platelets

Transfused

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing major atrhroplasty

You may qualify if:

  • Patients undergoing major atrhroplasty

You may not qualify if:

  • Pediatric patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Yildirim Beyazit Teaching and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

Related Publications (4)

  • Poitras S, Wood KS, Savard J, Dervin GF, Beaule PE. Predicting early clinical function after hip or knee arthroplasty. Bone Joint Res. 2015 Sep;4(9):145-51. doi: 10.1302/2046-3758.49.2000417.

    PMID: 26336897BACKGROUND
  • Cram P, Vaughan-Sarrazin MS, Wolf B, Katz JN, Rosenthal GE. A comparison of total hip and knee replacement in specialty and general hospitals. J Bone Joint Surg Am. 2007 Aug;89(8):1675-84. doi: 10.2106/JBJS.F.00873.

    PMID: 17671004BACKGROUND
  • Engoren M, Mitchell E, Perring P, Sferra J. The effect of erythrocyte blood transfusions on survival after surgery for hip fracture. J Trauma. 2008 Dec;65(6):1411-5. doi: 10.1097/TA.0b013e318157d9f9.

  • Kotze A, Carter LA, Scally AJ. Effect of a patient blood management programme on preoperative anaemia, transfusion rate, and outcome after primary hip or knee arthroplasty: a quality improvement cycle. Br J Anaesth. 2012 Jun;108(6):943-52. doi: 10.1093/bja/aes135.

MeSH Terms

Interventions

Blood Transfusion

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Dilek Yazicioglu, Assoc Prof

    Ministry of Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffesor

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 13, 2017

Study Start

October 15, 2017

Primary Completion

May 25, 2018

Study Completion

June 20, 2018

Last Updated

November 2, 2018

Record last verified: 2017-09

Locations