Blood-saving Effect of Combined Intravenous Tranexamic Acid With Topical Floseal® Application Total Hip Arthroplasty

Study Overview
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Brief Summary
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Total hip arthroplasty (THA) is an excellent surgical procedure for patients with end-stage hip diseases. However, THA is associated with considerable blood loss and increasing needs for allogenic blood transfusion. Tranexamic acid (TXA) was reportedly effective reducing total blood loss (TBL) after standard THA. However, a TBL of one L is still high for elderly patients. Floseal (Baxter, Deerfield, Illinois), a thrombin-based hemostatic agent, have been widely used in surgical procedure. However, there is no study investigating the effect of Floseal in THA procedures.This study anticipated that combination with the two different mechanism of topical hemostatic agent, Floseal, and intravenous TXA can bring a synergistic blood saving effect in THA patients. Purpose: Our purpose of this study therefore is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of combination of intravenous TXA and topical Floseal in a primary THA procedure. Material and Methods: The patients who are enrolled in this study will be assigned into three groups. The first group will be treated by combination of 1 g of TXA pre-operatively and two boluses TXA post-operatively intravenously and Floseal topical application, the second group by 1 g of TXA pre-operatively and two boluses TXA postoperatively intravenously without Floseal use, and the third group was control group which will be treated without TXA and Floseal. This study will observe whether there is difference in the blood-conservation effect by total blood loss calculation, hemoglobin loss and transfusion requirement between these three groups. This study anticipate that combined use of intravenous TXA and Floseal in THA procedure is more effective in decreasing blood loss and blood transfusion than intravenous TXA application alone, and this formula do not increase the risk of thromboembolic disease.

Official Title
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Blood-saving Effect of Combined Intravenous Tranexamic Acid With Topical Floseal® Application, a Comparison With Intravenous Tranexamic Acid Only in Total Hip Arthroplasty

Conditions
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Hip Replacement, Total

Intervention / Treatment
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* Drug: intravenous application of tranexamic acid
* Drug: Floseal hemostatic matrix
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with osteoarthritis of the hip secondary to degeneration, inflammatory arthritis, gouty arthritis, acetabular dysplasia or osteonecrosis of the femoral head, and undergoing primary unilateral minimally invasive THA Age > 18 years and < 90 years Failure of medical treatment or rehabilitation. Hemoglobin > 11g/dl, No use of non-steroid anti-inflammatory agent one week before operation Exclusion Criteria: Preoperative Hemoglobin ≦11 g/dl History of infection or intraarticular fracture of the affective hip Renal function deficiency (GFR <30 ml/min/1.73m2) Elevated liver enzyme (aspartate transaminase (AST)/ alanine transaminase(ALT) level are more than twice normal range) , history of liver cirrhosis, impaired liver function(elevated total bilirubin level) and coagulopathy (including long-term use anticoagulant) History of deep vein thrombosis, ischemic heart disease or stroke Contraindications of tranexamic acid, floseal, or rivaroxaban Allergy to tranexamic acid, floseal, rivaroxaban, or the excipients History of heparin-induced thrombocytopenia (HIT) Coagulopathy or bleeding tendency caused by organ dysfunction, such as cirrhosis, bone marrow suppression etc. Patient who have active bleeding disorder, such as intracranial hemorrhage, upper gastrointestinal bleeding, hematuria. Patients with known allergies to materials of bovine origin.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>Primary total hip replacement with application of Floseal hemostatic matrix on potential bleeding sites after prosthesis implantation, and intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later | Drug: intravenous application of tranexamic acid<br>* intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later.<br>* Other names: transamine;Drug: Floseal hemostatic matrix<br>* application of Floseal® on potential bleeding sites after prosthesis implantation<br>* Other names: Floseal;|
| Active Comparator: Group II<br>Primary total hip replacement with intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later | Drug: intravenous application of tranexamic acid<br>* intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later.<br>* Other names: transamine;|
| Placebo Comparator: Group III<br>Control group, neither TXA nor Floseal® will be used. Equivalent volume of normal saline injection pre- and post-operatively | Drug: Normal saline<br>* Equivalent volume of saline injection before incision, followed by two boluses (1g TXA) three hours later and six hours later.<br>* Other names: saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Blood Loss | The total blood loss was calculated according to Nadler et al, which uses maximum postoperative decrease of the Hb level adjusted for weight and height of the patient. Total blood loss consists of amount of blood loss calculated from the maximum Hb loss and amount of blood transfused | Post op day 4 | 
| Acute intraoperative Blood Loss | The intra-operative blood loss was recorded according to the volume of contents of the suction bottle and the estimated blood loss through weighing the swabs. The blood loss volume (ml) will be the volume of contents of the suction plus the increasing weight (gm) of swabs (supposing the proportion of blood is 1 gm/mL) | At the end of operation | 
| The change of Hemoglobin level | Check postoperative Hemoglobin level on postoperative day 1,2,4 | Preoperative day 1 to Post op day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood transfusion rate | We will record the event of blood transfusion, and calculate the incidence of transfusion | Within 3 months after operation | 
| Thrombosis risk evaluation | Detect the presence of deep-vein thrombosis of both lower limbs by duplex ultrasound study before discharge | Within 3 months after operation | 
| Incidence of wound complications | Wound complications including hematoma, skin necrosis and infection | Within 3 months after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thrombin, Total hip arthroplasty, Tranexamic acid, Floseal, postoperative blood loss