Blood-saving Effect of Combined Intravenous Tranexamic Acid With Topical Floseal® Application Total Hip Arthroplasty
NCT ID: NCT03623789
Last Updated: 2020-01-18
Study Results
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Basic Information
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UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2018-08-15
2020-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group I
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
intravenous application of tranexamic acid
intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later.
Floseal hemostatic matrix
application of Floseal® on potential bleeding sites after prosthesis implantation
Group II
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
intravenous application of tranexamic acid
intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later.
Group III
Control group, neither TXA nor Floseal® will be used. Equivalent volume of normal saline injection pre- and post-operatively
Normal saline
Equivalent volume of saline injection before incision, followed by two boluses (1g TXA) three hours later and six hours later.
Interventions
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intravenous application of tranexamic acid
intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later.
Floseal hemostatic matrix
application of Floseal® on potential bleeding sites after prosthesis implantation
Normal saline
Equivalent volume of saline injection before incision, followed by two boluses (1g TXA) three hours later and six hours later.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age \> 18 years and \< 90 years
3. Failure of medical treatment or rehabilitation.
4. Hemoglobin \> 11g/dl,
5. No use of non-steroid anti-inflammatory agent one week before operation
Exclusion Criteria
2. History of infection or intraarticular fracture of the affective hip
3. Renal function deficiency (GFR \<30 ml/min/1.73m2)
4. 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)
5. History of deep vein thrombosis, ischemic heart disease or stroke
6. Contraindications of tranexamic acid, floseal, or rivaroxaban
7. Allergy to tranexamic acid, floseal, rivaroxaban, or the excipients
8. History of heparin-induced thrombocytopenia (HIT)
9. Coagulopathy or bleeding tendency caused by organ dysfunction, such as cirrhosis, bone marrow suppression etc.
10. Patient who have active bleeding disorder, such as intracranial hemorrhage, upper gastrointestinal bleeding, hematuria.
11. Patients with known allergies to materials of bovine origin.
18 Years
90 Years
ALL
Yes
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Wang Jun-Wen
Professor
Principal Investigators
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Jun-Wen Wang, MD
Role: STUDY_CHAIR
Chang Gung Memorial Hospital
Locations
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Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Kubota R, Nozawa M, Matsuda K, Maezawa K, Kim SG, Maeda K, Ikegami T, Hayashi K, Nagayama M, Kaneko H. Combined preoperative autologous blood donation and intra-operative cell salvage for hip surgery. J Orthop Surg (Hong Kong). 2009 Dec;17(3):288-90. doi: 10.1177/230949900901700308.
Smith LK, Williams DH, Langkamer VG. Post-operative blood salvage with autologous retransfusion in primary total hip replacement. J Bone Joint Surg Br. 2007 Aug;89(8):1092-7. doi: 10.1302/0301-620X.89B8.18736.
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.
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Vamvakas EC, Blajchman MA. Transfusion-related mortality: the ongoing risks of allogeneic blood transfusion and the available strategies for their prevention. Blood. 2009 Apr 9;113(15):3406-17. doi: 10.1182/blood-2008-10-167643. Epub 2009 Feb 2.
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Kazemi SM, Mosaffa F, Eajazi A, Kaffashi M, Daftari Besheli L, Bigdeli MR, Zanganeh RF. The effect of tranexamic acid on reducing blood loss in cementless total hip arthroplasty under epidural anesthesia. Orthopedics. 2010 Jan;33(1):17. doi: 10.3928/01477447-20091124-30.
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Xie J, Ma J, Yao H, Yue C, Pei F. Multiple Boluses of Intravenous Tranexamic Acid to Reduce Hidden Blood Loss After Primary Total Knee Arthroplasty Without Tourniquet: A Randomized Clinical Trial. J Arthroplasty. 2016 Nov;31(11):2458-2464. doi: 10.1016/j.arth.2016.04.034. Epub 2016 May 6.
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Other Identifiers
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201701718A3
Identifier Type: -
Identifier Source: org_study_id
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