Kaolin-based Hemostatic Gauze in Total Knee Arthroplasty

  • STATUS
    Recruiting
  • End date
    Jul 31, 2023
  • participants needed
    120
  • sponsor
    Chang Gung Memorial Hospital
Updated on 7 October 2022
Accepts healthy volunteers

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.

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

Details
Condition Total Blood Loss, Arthropathy of Knee Joint
Treatment Tranexamic acid injection, apply the QCG, apply surgical gauze
Clinical Study IdentifierNCT05504577
SponsorChang Gung Memorial Hospital
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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

Preoperative Hemoglobin <11 g/dl
History of infection or intraarticular fracture of the affective knee
Renal function deficiency (GFR <30 ml/min/1.73m2)
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)
History of deep vein thrombosis, ischemic heart disease or stroke, in which life-long oral anticoagulant are required
Contraindications of tranexamic acid, or rivaroxaban
Allergy to tranexamic acid, kaolin, 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 GI bleeding, hematuria
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