Reducing Blood Loss Using Tisseel in TKA

NCT ID: NCT03310060

Last Updated: 2017-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2018-12-31

Brief Summary

The purpose of this study is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of the topical hemostatic agents in patients receiving primary TKA procedures. The investigators will also observe if there is increased risk of blood transfusion rate by using topical hemostatic agents or not.

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 6% to 38% after standard TKAs. Transfusion carries significant risks of cardiopulmonary embarrassment, disease transmission, immunological reaction and postoperative infection.

The major causes of postoperative blood loss following TKA are attributed to surgery itself which induces a considerable activation of the coagulation cascade and local fibrinolysis, the latter is further enhanced after release of the tourniquet at the end of surgery. Tranexamic acid (TXA), an inhibitor of fibrinolysis, was reportedly effective reducing blood loss after standard TKA. Previous experiences in minimally invasive (MIS) TKA showed that intraoperative infusion of TXA reduced 45% of postoperative blood loss and needs for transfusion from 20% to 4%. However, the safety to use TXA systemically in TKAs especially in high risk patients remains controversial. A recent study by Nishihara et al. demonstrated that use of TXA in total hip arthroplasty did not appear to affect the prevalence of either proximal DVT or PE. Another study by Xie J et al. also showed the incidence of postoperative VTE was unchanged when TXA was administered in primary unilateral TKA, but in their study the total occurrence of vascular occlusive events was statistically significantly higher (17.55% Vs 9.35%, p < 0.001) in the TXA group. However, in this two studies the patient with high risk of thromboembolic events (ischemic heart disease, chronic renal failure on hemodialysis, cerebral infarction, previous VTE disease, thrombophilia associated with genetic diseases) were excluded.

The investigators believe the use of hemostatic agent topically in patients with high risk of thromboembolism can avoid its systematic effect and decrease its potential perioperative risk of thromboembolic complications (arterial thrombosis, myocardial infarction and pulmonary embolism). On the other hand, thrombin-based hemostatic agents, Tisseel®, have been widely used in surgical procedure including gynecology, general surgery, and orthopedics which were still attracting the attention and interest of multitudinous surgeons. Some recent studies demonstrated that topic use of Tisseel® in primary TKA can reduce hemoglobin decline and calculated total blood loss after TKA and is not related to adverse reactions or complications such as wound infection, venous thromboembolism events(VTE). But there were another studies showed Tisseel® does not reduce blood loss in TKA procedures.

The purpose of this study therefore is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of the topic hemostatic agents and their safety in a primary TKA procedures in patients with risk of thromboembolic events. The first group by topical Tisseel and intravenous TXA application, and the second group of placebo IV TXA then observe whether there is difference in the blood-conservation effect by total blood loss calculation, hemoglobin loss and transfusion requirement among different groups.

Conditions

Total Blood Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Tisseel combined Tranexamic acid

Drug: Tisseel® Applied on potential bleeding sites. The entire content was 4 mL.

Drug: Tranexamic acid Intravenous application of tranexamic acid 15mg/kg before surgical incision and 3 hours after surgery

Group Type: ACTIVE_COMPARATOR

Tisseel

Intervention Type: DRUG

Tisseel® (Fibrin Sealant, 4ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 4 mL vial containing the active product was used

Tranexamic Acid

Intervention Type: DRUG

Drug: Tranexamic acid Intravenous application of tranexamic acid 15mg/kg in 100 ml normal saline before surgical incision and 3 hours after surgery

Tranexamic acid

Drug: Tranexamic acid Intravenous application of tranexamic acid 15mg/kg before surgical incision and 3 hours after surgery

Group Type: PLACEBO_COMPARATOR

Tranexamic Acid

Intervention Type: DRUG

Drug: Tranexamic acid Intravenous application of tranexamic acid 15mg/kg in 100 ml normal saline before surgical incision and 3 hours after surgery

Interventions

Tisseel

Tisseel® (Fibrin Sealant, 4ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 4 mL vial containing the active product was used

Intervention Type: DRUG

Tranexamic Acid

Drug: Tranexamic acid Intravenous application of tranexamic acid 15mg/kg in 100 ml normal saline before surgical incision and 3 hours after surgery

Intervention Type: DRUG

Other Intervention Names

Fibrin Sealant; Transamin

Eligibility Criteria

Inclusion Criteria

• After cardiologist or neurologist's evaluation, patients who was classified as low-risk of perioperative risk with advanced knee osteoarthritis who was failure of medical treatment or rehabilitation and within age limit

Exclusion Criteria

• Preoperative Hemoglobin ≦12 g/dl History of infection or intraarticular fracture of the affective knee, Renal function deficiency (GFR < 30 ml/min/1.73m2), Elevated liver enzyme, history of liver cirrhosis, impaired liver function and coagulopathy

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

201700271A3

Identifier Type: -

Identifier Source: org_study_id