Kaolin-based Hemostatic Gauze in Total Knee Arthroplasty

Phase 4

• Conditions: Total Blood Loss; Arthropathy of Knee Joint
• Interventions: Drug: Tranexamic acid injection; Device: apply the QCG; Device: apply surgical gauze

• Registration Number: NCT05504577
• Lead Sponsor: Chang Gung Memorial Hospital

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

Study Timeline

• Study Start: 2022-03-16
• Status Verified: 2022-08
• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-17
• Last Update Submitted: 2022-09-07
• Last Update Posted: 2022-09-10
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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..

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Tranexamic acid injection	fter the prosthesis are all implanted, we close the joint capsule directly. Tranexamic acid 1g is intravenously injected at 10 mins before tourniquet deflation. .
QCG group	Tranexamic acid injection	After the prosthesis are all implanted, apply the QCG (Quikclot Z-fold hemostatic gauze, Z-Medica, Wallingford, CT, USA) into the joint space. Compress the knee joint by elastic bandage. Deflate the tourniquet for 10 minutes, then remove the QCG from the knee joint and throughout check bleeders before closure of the joint capsule. Tranexamic acid 1g is intravenously injected at 10 mins before tourniquet deflation
Surgical gauze group	Tranexamic acid injection	After the prosthesis are all implanted, apply the surgical gauze into the joint space. Compress the knee joint by elastic bandage. Deflate the tourniquet for 10 minutes, then remove the gauze from the joint and throughout check bleeders before closure of the joint capsule. Tranexamic acid 1g is intravenously injected at 10 mins before tourniquet deflation
QCG group	apply the QCG	After the prosthesis are all implanted, apply the QCG (Quikclot Z-fold hemostatic gauze, Z-Medica, Wallingford, CT, USA) into the joint space. Compress the knee joint by elastic bandage. Deflate the tourniquet for 10 minutes, then remove the QCG from the knee joint and throughout check bleeders before closure of the joint capsule. Tranexamic acid 1g is intravenously injected at 10 mins before tourniquet deflation
Surgical gauze group	apply surgical gauze	After the prosthesis are all implanted, apply the surgical gauze into the joint space. Compress the knee joint by elastic bandage. Deflate the tourniquet for 10 minutes, then remove the gauze from the joint and throughout check bleeders before closure of the joint capsule. Tranexamic acid 1g is intravenously injected at 10 mins before tourniquet deflation

Primary Outcome Measures

Name	Time	Method
Total Blood Loss	Preoperative day to postoperative day 4	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

Secondary Outcome Measures

Name	Time	Method
Blood transfusion rate	To three months after operation	We will record the event of blood transfusion, and calculate the incidence of transfusion
All symptomatic thrombotic events including deep vein thrombosis, pulmonary embolism	To three months after operation	We will record all symptomatic thrombotic events including deep vein thrombosis, pulmonary embolism in our study, and calculate the incidence of them

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan