Blood-saving Effect of Combined Intravenous Tranexamic Acid With Topical Floseal® Application Total Hip Arthroplasty

Phase 4

• Conditions: Hip Replacement, Total
• Interventions: Drug: intravenous application of tranexamic acid; Drug: Normal saline; Drug: Floseal hemostatic matrix

• Registration Number: NCT03623789
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

Total hip arthroplasty (THA) is an excellent surgical procedure for patients with end-stage hip diseases. However, THA is associated with considerable blood loss and increasing needs for allogenic blood transfusion. Tranexamic acid (TXA) was reportedly effective reducing total blood loss (TBL) after standard THA. However, a TBL of one L is still high for elderly patients.

Floseal (Baxter, Deerfield, Illinois), a thrombin-based hemostatic agent, have been widely used in surgical procedure. However, there is no study investigating the effect of Floseal in THA procedures.This study anticipated that combination with the two different mechanism of topical hemostatic agent, Floseal, and intravenous TXA can bring a synergistic blood saving effect in THA patients.

Purpose:

Our purpose of this study therefore is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of combination of intravenous TXA and topical Floseal in a primary THA procedure.

Material and Methods:

The patients who are enrolled in this study will be assigned into three groups. The first group will be treated by combination of 1 g of TXA pre-operatively and two boluses TXA post-operatively intravenously and Floseal topical application, the second group by 1 g of TXA pre-operatively and two boluses TXA postoperatively intravenously without Floseal use, and the third group was control group which will be treated without TXA and Floseal. This study 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.

This study anticipate that combined use of intravenous TXA and Floseal in THA procedure is more effective in decreasing blood loss and blood transfusion than intravenous TXA application alone, and this formula do not increase the risk of thromboembolic disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-09
• Study Start: 2018-08-15
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-16
• Last Update Posted: 2020-01-18
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Patients with osteoarthritis of the hip secondary to degeneration, inflammatory arthritis, gouty arthritis, acetabular dysplasia or osteonecrosis of the femoral head, and undergoing primary unilateral minimally invasive THA
2. Age > 18 years and < 90 years
3. Failure of medical treatment or rehabilitation.
4. Hemoglobin > 11g/dl,
5. No use of non-steroid anti-inflammatory agent one week before operation

Exclusion Criteria

1. Preoperative Hemoglobin ≦11 g/dl
2. History of infection or intraarticular fracture of the affective hip
3. Renal function deficiency (GFR <30 ml/min/1.73m2)
4. Elevated liver enzyme (aspartate transaminase (AST)/ alanine transaminase(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
6. Contraindications of tranexamic acid, floseal, or rivaroxaban
7. Allergy to tranexamic acid, floseal, 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 gastrointestinal bleeding, hematuria.
11. Patients with known allergies to materials of bovine origin.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II	intravenous application of tranexamic acid	Primary total hip replacement with intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later
Group III	Normal saline	Control group, neither TXA nor Floseal® will be used. Equivalent volume of normal saline injection pre- and post-operatively
Group I	intravenous application of tranexamic acid	Primary total hip replacement with application of Floseal hemostatic matrix on potential bleeding sites after prosthesis implantation, and intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later
Group I	Floseal hemostatic matrix	Primary total hip replacement with application of Floseal hemostatic matrix on potential bleeding sites after prosthesis implantation, and intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later

Primary Outcome Measures

Name	Time	Method
Acute intraoperative Blood Loss	At the end of operation	The intra-operative blood loss was recorded according to the volume of contents of the suction bottle and the estimated blood loss through weighing the swabs. The blood loss volume (ml) will be the volume of contents of the suction plus the increasing weight (gm) of swabs (supposing the proportion of blood is 1 gm/mL)
The change of Hemoglobin level	Preoperative day 1 to Post op day 4	Check postoperative Hemoglobin level on postoperative day 1,2,4
Total Blood Loss	Post op 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	Within 3 months after operation	We will record the event of blood transfusion, and calculate the incidence of transfusion
Incidence of wound complications	Within 3 months after operation	Wound complications including hematoma, skin necrosis and infection
Thrombosis risk evaluation	Within 3 months after operation	Detect the presence of deep-vein thrombosis of both lower limbs by duplex ultrasound study before discharge

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan