NCT05504577

Kaolin-based Hemostatic Gauze in Total Knee Arthroplasty

Blood-saving Effect of Kaolin-based Hemostatic Gauze Combined With Intravenous Tranexamic Acid in Total Knee Arthroplasty

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Accepted

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

Conditions

• Total Blood Loss
• Arthropathy of Knee Joint

Interventions

Type	Name	Description
DRUG	Tranexamic acid injection	Tranexamic acid 1g is intravenously injected at 10 mins before tourniquet deflation. .
DEVICE	apply the QCG	apply the QCG (Quikclot Z-fold hemostatic gauze, Z-Medica, Wallingford, CT, USA) into the joint space. Compress the knee joint by elastic bandage. Compress the knee joint by elastic bandage. Deflate the tourniquet for 10 minutes
DEVICE	apply surgical gauze	apply the normal surgical gauze into the joint space. Compress the knee joint by elastic bandage. Deflate the tourniquet for 10 minutes

Timeline

• Start date: 2022-03-16
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2022-08-17
• Last updated: 2022-09-10

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated device study