Blood Transfusion Applications in Hip Replacements

Blood Transfusion Clinical Trial

Official title:

Blood Transfusion Applications in Hip Replacements: A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05627544
• Other study ID #: KA22/430
• Status: Completed
• Start date: November 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: March 2023
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Introduction and Aim In the intraoperative or postoperative period of hip replacement surgeries, approximately 46% of patients receive erythrocyte transfusion. 'Patient blood management' protocols have been established in order to reduce the frequency of perioperative surgical bleeding and transfusion. The aim of this study is to evaluate the patients who underwent hip replacement by the same experienced surgeon; to evaluate retrospectively in terms of patient characteristics, surgical and anesthesia management, blood transfusion frequency.

Methods The characteristics of patients who underwent hip replacement (total hip replacement, revision hip replacement, partial hip replacement) operation by the same experienced surgeon between 2010-2022 at Baskent University after the approval of Baskent University Medical and Health Sciences Research Board, results will be analyzed retrospectively through perioperative follow-up forms and review of patient files.

Expectations and scientific contributions Preparing patients for surgery, determining the causes of blood loss during and after surgery and creating preventive strategies are important for all operations, especially hip replacement surgeries. While determining the strategies, the main aim should be to see the pre-, intra- and post-operative period as a whole, to determine the transfusion risks according to the comorbidities and anemia of the patients, and to determine the anesthesia and analgesia managements that reduce blood loss in the intraoperative and postoperative periods.

Description:

Introduction and Aim Hip replacement surgeries are among the operations whose frequency is increasing in our country and in the world. In these operations, procedures such as soft tissue dissection, exposing the hypervascular metaphysis and bone resection cause acute blood loss and continue in the form of leakage in the postoperative period. It has been reported that the rate of blood transfusion in hip operations in the United States is between 18-68%. There are studies reporting that erythrocyte transfusion rate approximately 46% of these cases in the intraoperative or postoperative period. Various complications may develop in patients during or after blood transfusion. These complications include local or systemic infections, venous thromboembolic events, allergic reactions, circulatory overload, transfusion-induced acute lung injury, morbidity, mortality, and increased hospital stay. In addition, a significant increase in cost can be seen. It is thought that the amount of bleeding varies according to the duration of the operation, the experience of the surgeon, and the type of surgery. Therefore, it is important for patient safety to reduce surgical bleeding and avoid transfusion applications as much as possible.

"Patient blood management" has been defined as, to reduce the frequency of perioperative surgical bleeding and transfusion. Perioperative patient blood management practices, correction of preoperative anemia, autologous blood donation, discontinuation of blood thinners, acute normovolemic hemodilution, use of tranexamic acid, regional anesthesia, controlled hypotension, avoidance of hypothermia, appropriate fluid management, meticulous surgery, appropriate hemostasis, patient position, postoperative drain strategy. 'Patient blood management' measures are actively applied in hip replacement surgeries, which are one of the major orthopedic surgeries.

The aim of this study is to evaluate the patients who underwent hip replacement by the same experienced surgeon in this center; to evaluate retrospectively in terms of patient characteristics, surgical and anesthesia management, blood transfusion frequency.

Methods The characteristics of patients who underwent hip replacement (total hip replacement, revision hip replacement, partial hip replacement) operation by the same experienced surgeon between 2010-2022 at Baskent University after the approval of Baskent University Medical and Health Sciences Research Board, It will be analyzed retrospectively through perioperative follow-up forms and review of patient files.

From preoperative records; Demographic data (Age, sex, height, body weight), diagnoses (Hip arthrosis, hip revision, hip fracture, congenital hip dislocation, infected hip replacement revision), American Society of Anesthesiologists Physical Condition Classification (ASA), co-morbidities (Hypertension, diabetes, chronic kidney failure, hepatopathy, inflammatory disease), smoking, alcohol, antiplatelet/anticoagulant, nonsteroidal anti-inflammatory use (NSAII), opioid, herbal medicine use, antiplatelet cut-off time compliance, hemoglobin (Hb), hematocrit (Htc), leukocytes, thrombocyte, activated partial thromboplastin time (APTT), prothrombin time (PTZ), international normalized ratio (INR), preoperative erythrocyte (ES) transfusion/amount.

From intraoperative records; Year of operation, mallampati score, type of operation, duration of operation, whether emergency or elective, duration of anesthesia, type of anesthesia, intraoperative blood pressure (systolic and diastolic), heart rate, peripheral oxygen saturation, amount/type of fluid administered, ES transfusion/ amount, Hb when transfused, drugs used for anesthesia and analgesia and their amount, amount of blood in the aspirator, administration of tranexamic acid, amount of intraoperative urine.

From the postoperative records; Hb/Htc values, ES transfusion/amount/day of administration, use of drain, amount of blood in the drain, amount of postoperative urine, intensive care unit admission, initiation of anticoagulants, early and late complications (Atrial fibrillation, pneumonia , renal failure, prosthesis infection, allergic reactions, nausea-vomiting), postoperative analgesia (Epidural/intravenous patient-controlled analgesia, opioid and NSAID use), Hb, urea, creatinine values at postoperative 6th and 12th hours and at discharge, iron preparation use, The number of hospitalization days and the mortality within 7 days will be recorded and the data will be compared.

Statistical analysis Statistical analysis will be performed using SPSS (SPSS Inc. Chicago, Illinois, USA) version 20.0 of the statistical program. Descriptive statistical methods (frequency, percentage, mean, standard deviation) will be used while evaluating the study data. The Kolmogorov-Smirnov test will be used to evaluate the conformity of the data of the patients with and without ES transfusion to normal distribution. T-test will be used in the analysis of data suitable for normal distribution, Kruskal-Wallis test or Mann Whitney U test will be used in the analysis of data not suitable for normal distribution. X² will be used in the analysis of qualitative or counted data. p<0.05 will be considered significant.

Expectations and scientific contributions Preparing patients for surgery, determining the causes of blood loss during and after surgery and creating preventive strategies are important for all operations, especially hip replacement surgeries. While determining the strategies, the main aim should be to see the pre-, intra- and post-operative period as a whole, to determine the transfusion risks according to the comorbidities and anemia of the patients, and to determine the anesthesia and analgesia managements that reduce blood loss in the intraoperative and postoperative periods. With this study, it is aimed to both update the practice and contribute to the literature by examining the operations performed by the same experienced surgeon and testing the effectiveness and safety of the strategies applied.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: December 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients who have undergone hip replacement by the same experienced surgeon in the last 12 years

Exclusion Criteria:

• Patients with insufficient data will be excluded from the study.

Related Conditions & MeSH terms

• Blood Transfusion
• Hip Replacement

Intervention

Procedure:
• Anesthesia management/Hip replacement surgery
The effect of anesthesia management on blood transfusion practices in hip replacement surgeries
• Demographic data
The effect of demographic data on blood transfusion practices in hip replacement surgeries
• Chronic diseases
The effect of chronic diseases on blood transfusion practices in hip replacement surgeries
• Postoperative complication
The effect of blood transfusion applications on postoperative complications in hip replacement surgeries

Locations

Country	Name	City	State
Turkey	Baskent University Zubeyde Hanim Practice and Research Center	Izmir	Karsiyaka

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

References & Publications (13)

Artroplasty Society of Australia. Guidelines for venous thrombotic episode prophylaxis for hip and knee arthroplasty. Australian Orthopaedic Association 2010

Bierbaum BE, Callaghan JJ, Galante JO, Rubash HE, Tooms RE, Welch RB. An analysis of blood management in patients having a total hip or knee arthroplasty. J Bone Joint Surg Am. 1999 Jan;81(1):2-10. doi: 10.2106/00004623-199901000-00002. — View Citation

Browne JA, Adib F, Brown TE, Novicoff WM. Transfusion rates are increasing following total hip arthroplasty: risk factors and outcomes. J Arthroplasty. 2013 Sep;28(8 Suppl):34-7. doi: 10.1016/j.arth.2013.03.035. Epub 2013 Jul 26. — View Citation

Carling MS, Jeppsson A, Eriksson BI, Brisby H. Transfusions and blood loss in total hip and knee arthroplasty: a prospective observational study. J Orthop Surg Res. 2015 Mar 28;10:48. doi: 10.1186/s13018-015-0188-6. — View Citation

Menendez ME, Lu N, Huybrechts KF, Ring D, Barnes CL, Ladha K, Bateman BT. Variation in Use of Blood Transfusion in Primary Total Hip and Knee Arthroplasties. J Arthroplasty. 2016 Dec;31(12):2757-2763.e2. doi: 10.1016/j.arth.2016.05.022. Epub 2016 May 18. — View Citation

Pedersen AB, Mehnert F, Overgaard S, Johnsen SP. Allogeneic blood transfusion and prognosis following total hip replacement: a population-based follow up study. BMC Musculoskelet Disord. 2009 Dec 29;10:167. doi: 10.1186/1471-2474-10-167. — View Citation

Ponnusamy KE, Kim TJ, Khanuja HS. Perioperative blood transfusions in orthopaedic surgery. J Bone Joint Surg Am. 2014 Nov 5;96(21):1836-44. doi: 10.2106/JBJS.N.00128. — View Citation

Saleh A, Small T, Chandran Pillai AL, Schiltz NK, Klika AK, Barsoum WK. Allogenic blood transfusion following total hip arthroplasty: results from the nationwide inpatient sample, 2000 to 2009. J Bone Joint Surg Am. 2014 Sep 17;96(18):e155. doi: 10.2106/JBJS.M.00825. — View Citation

Song K, Pan P, Yao Y, Jiang T, Jiang Q. The incidence and risk factors for allogenic blood transfusion in total knee and hip arthroplasty. J Orthop Surg Res. 2019 Aug 28;14(1):273. doi: 10.1186/s13018-019-1329-0. — View Citation

Spahn DR. Anemia and patient blood management in hip and knee surgery: a systematic review of the literature. Anesthesiology. 2010 Aug;113(2):482-95. doi: 10.1097/ALN.0b013e3181e08e97. — View Citation

Taylor RW, Manganaro L, O'Brien J, Trottier SJ, Parkar N, Veremakis C. Impact of allogenic packed red blood cell transfusion on nosocomial infection rates in the critically ill patient. Crit Care Med. 2002 Oct;30(10):2249-54. doi: 10.1097/00003246-200210000-00012. — View Citation

Tezcan B. Etkin hasta kan yönetimi. JARSS 2019; 27: 162-73.

Tuttle JR, Ritterman SA, Cassidy DB, Anazonwu WA, Froehlich JA, Rubin LE. Cost benefit analysis of topical tranexamic acid in primary total hip and knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1512-5. doi: 10.1016/j.arth.2014.01.031. Epub 2014 Feb 3. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of preoperative, peroperative and postoperative blood transfusion	The amount of blood transfusion administered to patients who have undergone hip replacement surgery by the same experienced surgeon in the last 12 years will be measured and compared during their hospitalization.	Up to 1 week
Secondary	Anesthesia management	The effects of preoperative preparation for surgery, anesthesia applications during the operation, and analgesia applications in the postoperative period on the amount of blood transfusion in patients hospitalized for hip replacement surgery will be determined.	Up to 1 week