A Survey on Blood Transfusions in Major Artrhoplasty Operations

NCT ID: NCT03282201

Last Updated: 2018-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

418 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-15

Study Completion Date

2018-06-20

Brief Summary

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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.

Detailed Description

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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

Conditions

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Arthropathy of Hip Arthropathy of Knee

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Transfused

Patients in whom blood transfusion is used

Transfusion

Intervention Type OTHER

Transfusion of red blood cells, fresh frozen plasma, platelets

Nontransfused

Patients in whom blood transfusion is not used

No interventions assigned to this group

Interventions

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Transfusion

Transfusion of red blood cells, fresh frozen plasma, platelets

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing major atrhroplasty

Exclusion Criteria

* Pediatric patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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DILEK YAZICIOGLU

Associate Proffesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dilek Yazicioglu, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health

Locations

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Diskapi Yildirim Beyazit Teaching and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 26336897 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17671004 (View on PubMed)

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.

Reference Type RESULT
PMID: 19077635 (View on PubMed)

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.

Reference Type RESULT
PMID: 22593128 (View on PubMed)

Other Identifiers

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TransfusionArthroplasty

Identifier Type: -

Identifier Source: org_study_id

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