Clinical trial NCT03310060: Reducing Blood Loss Using Tisseel in TKA
Official title: Reducing Blood Loss During Total Knee Arthroplasty Using Tisseel: A Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Total Blood Loss
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Total blood loss after operation
timeFrame: from the operation to the postoperative day 3
Secondary outcomes:
measure: Incidence of any thrombotic events
timeFrame: within 30 days of the operation
measure: Incidence of wound infection after surgery
timeFrame: within 30 days of the operation
measure: Blood transfusion requirement
timeFrame: from the operation to postoperative day 14
measure: Calculated blood loss from drainage
timeFrame: from the operation to the postoperative day 2 until drainage removal
Other outcomes:
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