Clinical trial NCT05504577: Kaolin-based Hemostatic Gauze in Total Knee Arthroplasty
Official title: Blood-saving Effect of Kaolin-based Hemostatic Gauze Combined With Intravenous Tranexamic Acid in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Total Blood Loss
Arthropathy of Knee Joint
Keywords: Postoperative blood loss
Total knee arthroplasty
kaolin-impregnated gauze
tranexamic acid
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of combination of intravenous TXA and QCG in a primary TKA procedure.

Detailed description: Total knee arthroplasty (TKA) is associated with considerable blood loss and increasing needs for allogenic blood transfusion. Previous studies demonstrated a transfusion rates ranging from 10% to 38% after standard TKAs. Tranexamic acid (TXA), an inhibitor of fibrinolysis, was reportedly effective reducing blood loss after standard TKA. Our previous experiences in minimally invasive (MIS) TKA showed that intraoperative intravenous infusion of TXA reduced 45% of postoperative blood loss and needs for transfusion from 20% to 4%. Our study demonstrated that an equal efficacy of intraarticular topical TXA in blood conservation compared with intravenous infusion of TXA.

In addition to TXA, the Quikclot sponge (QCG; Z-Medica, Wallingford, CT, USA) is a newly developed hemostatic agent employing an inorganic mineral (kaolin). The QCG has predominantly been used in combat settings and trauma surgery. Recently, the application of QCG in interventional procedures, and non-orthopedic surgeries was reported. Literature describing the use of QCG as an alternative approach to achieve hemostasis in the field of orthopedics is limited. There is no study to investigate the blood-saving effect of QCG in a TKA procedure, especially in combined with TKA. Therefore we conduct the study to understand the efficacy of this sponge on blood conservation in TKA We believe that combination with the two different mechanism of blood-conservation agents can bring a synergistic effect in blood saving after TKA. Our purpose of this study therefore is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of QCG combined with TXA use.

Material and Methods:

The patients who are enrolled in this study will be randomly assigned into three groups. We plan to recruit 60 patients in each group (total case number is 120). The first group will be treated by application of QCG in joint space and TXA 1g intravenous injection before tourniquet deflation. The second group will be treated by application of normal gauze in joint space and TXA 1g intravenous injection before tourniquet deflation. The third group will be treated only TXA 1g intravenously injection alone before tourniquet deflation. We 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. Besides, any complications including VTE, deep infection, wound complications within postoperative 3 months will be recorded.

Study years: two years

Eligibility criteria: Inclusion Criteria:

* Patients with advanced osteoarthritis of the knee and undergo primary unilateral minimally invasive TKA
* Age \> 50 years and \< 90 years
* Failure of medical treatment or rehabilitation
* Hemoglobin ≧ 11g/dl
* No use of non-steroid anti-inflammatory agent, antiplatelets or anticoagulants at least 3 days before operation

Exclusion Criteria:

1. Preoperative Hemoglobin \<11 g/dl
2. History of infection or intraarticular fracture of the affective knee
3. Renal function deficiency (GFR \<30 ml/min/1.73m2)
4. Elevated liver enzyme (AST/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, in which life-long oral anticoagulant are required.
6. Contraindications of tranexamic acid, or rivaroxaban
7. Allergy to tranexamic acid, kaolin, 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 GI bleeding, hematuria..

Primary outcomes:
measure: Total Blood Loss
timeFrame: Preoperative day to postoperative day 4
Secondary outcomes:
measure: Blood transfusion rate
timeFrame: To three months after operation
measure: All symptomatic thrombotic events including deep vein thrombosis, pulmonary embolism
timeFrame: To three months after operation
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Orthopaedic Surgery, Kaohsiung Chang Gung Memorial Hospital
name: Jun-Wen Wang, MD
role: STUDY_DIRECTOR
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