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CompletedNCT03282201Updated Nov 2, 2018

A Survey on Blood Transfusions in Major Artrhoplasty Operations

An observational study in Arthropathy of Hip and Arthropathy of Knee, sponsored by Diskapi Teaching and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2018-11-02.

Sponsored by Diskapi Teaching and Research Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
418
Ages
18 Years to 95 Years
Sex
All
01

Study 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.

Read the detailed description

After obtaining ethical approval Patients undergoing hip or knee arthroplasty or revision arthroplasty will be included in this prospective observational study.

Patient characteristics (age , gender, body mass index, ASA physical status, anticoagulant medication) Preoperative: hemoglobin, hematocrit, platelet, INR, APTT, PT values, the precence of preoperative anemia, anemia treatment modalities will be recorded.

Intraopreative: type and duration of surgery, anesthesia method, monitoring methods used, the amount of intraoprative adminestred fluids (crystalloid-colloid), amount of hemorrhage Postoperative: hemoglobin-hematocrit-platelet leve The amount of blood transfusion and the product used (erythrocyte suspension, fresh frozen plasma, thrombocyte-fibrinogen-factor concentration-cryoprecipitate-other ) Hemoglobin-hematocrit-platelet level before and after transfusion Indications for transfusion; hemoglobin threshold / physiological transfusion indicator; tachycardia, hypotension, low flow rate, desaturation, low SvO2, inotropic requirement, etc. / comorbidities / monitorisation findings, other, Discharge time of patients Early upright position (postoperative 2nd day), information on walking capacities (TUG - The Time Up and Go test) will be recorded and compared between transfused and non-transfused patients

02

Conditions studied

  • Arthropathy of Hip
  • Arthropathy of Knee

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03

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing major atrhroplasty

Inclusion criteria

  • Patients undergoing major atrhroplasty

Exclusion criteria

Exclusion Criteria:

  • Pediatric patients
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
418 participants (actual)
Patient registry
No

Groups and cohorts

  • Transfused

    Patients in whom blood transfusion is used

    Other: Transfusion

  • Nontransfused

    Patients in whom blood transfusion is not used

Interventions

  • OtherTransfusion

    Transfusion of red blood cells, fresh frozen plasma, platelets

05

What researchers measure

Primary outcomes

  1. Discharge time

    Discharge time from hospital

    Time frame: Postoperative day 1-6 days

  2. TUG test

    Walking without help

    Time frame: Postoperative day 1-2

06

Study locations

1 site
  • Diskapi Yildirim Beyazit Teaching and Research Hospital
    Ankara, 06110, Turkey
07

References and documents

Publications

  • 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. PubMed 26336897 ↗
  • 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. PubMed 17671004 ↗
  • 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. PubMed 19077635 ↗
  • 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. PubMed 22593128 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03282201
Lead sponsor
Diskapi Teaching and Research Hospital
Responsible party
DILEK YAZICIOGLU (Associate Proffesor, Diskapi Teaching and Research Hospital) — Principal investigator
First posted
Sep 13, 2017
Start date
Oct 15, 2017
Primary completion
May 25, 2018
Completion
Jun 20, 2018
Last update
Nov 2, 2018

Study contacts

Dilek Yazicioglu, Assoc Prof
principal investigator · Ministry of Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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