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OpenTrials
Completed

NCT Number: NCT03282201

A Survey on Blood Transfusions in Major Artrhoplasty Operations

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.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Diskapi Yildirim Beyazit Teaching and Research Hospital

Ankara, 06110, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing major atrhroplasty

Exclusion criteria

  • Pediatric patients

Treatment and study plan

Transfusion

Other

Transfusion of red blood cells, fresh frozen plasma, platelets

Primary outcomes

  1. Discharge time

    Time frame: Postoperative day 1-6 days

    Discharge time from hospital

  2. TUG test

    Time frame: Postoperative day 1-2

    Walking without help

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Registry information

Official study title

The Effect of Blood Transfusion on Recovery After Major Arthroplasties

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2017
Registry last updated
Nov 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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