A Survey on Blood Transfusions in Major Artrhoplasty Operations

Arthropathy of Knee Clinical Trial

Official title:

The Effect of Blood Transfusion on Recovery After Major Arthroplasties

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282201
• Other study ID #: TransfusionArthroplasty
• Status: Completed
• Start date: October 15, 2017
• Est. completion date: June 20, 2018

Study information

• Verified date: September 2017
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: June 20, 2018
• Est. primary completion date: May 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Patients undergoing major atrhroplasty

Exclusion Criteria:

• Pediatric patients

Related Conditions & MeSH terms

• Arthropathy of Hip
• Arthropathy of Knee
• Joint Diseases

Intervention

Other:
• Transfusion
Transfusion of red blood cells, fresh frozen plasma, platelets

Locations

Country	Name	City	State
Turkey	Diskapi Yildirim Beyazit Teaching and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

Kotzé 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/bj — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discharge time	Discharge time from hospital	Postoperative day 1-6 days
Primary	TUG test	Walking without help	Postoperative day 1-2