A Survey on Blood Transfusions in Major Artrhoplasty Operations
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|ClinicalTrials.gov Identifier: NCT03282201|
Recruitment Status : Not yet recruiting
First Posted : September 13, 2017
Last Update Posted : September 14, 2017
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.
|Condition or disease||Intervention/treatment|
|Arthropathy of Hip Arthropathy of Knee||Other: Transfusion|
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
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||The Effect of Blood Transfusion on Recovery After Major Arthroplasties|
|Estimated Study Start Date :||October 15, 2017|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||December 2017|
Patients in whom blood transfusion is used
Transfusion of red blood cells, fresh frozen plasma, platelets
Patients in whom blood transfusion is not used
- Discharge time [ Time Frame: Postoperative day 1-6 days ]Discharge time from hospital
- TUG test [ Time Frame: Postoperative day 1-2 ]Walking without help
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282201
|Contact: Dilek Yazicioglu, Assoc Proffirstname.lastname@example.org|
|Principal Investigator:||Dilek Yazicioglu, Assoc Prof||Netherlands: Ministry of Health, Welfare and Sports|