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

NCT03623789 | Unknown Phase 4

• 1 other identifier: 201701718A3
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Replacement, Total

Keywords

Total hip arthroplasty; Tranexamic acid; Floseal; postoperative blood loss; Thrombin

Outcome Measures

Primary Outcomes (3)

• Total Blood Loss

  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

  Post op day 4

• Acute intraoperative Blood Loss

  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)

  At the end of operation

• The change of Hemoglobin level

  Check postoperative Hemoglobin level on postoperative day 1,2,4

  Preoperative day 1 to Post op day 4

Secondary Outcomes (3)

• Blood transfusion rate

  Within 3 months after operation

• Thrombosis risk evaluation

  Within 3 months after operation

• Incidence of wound complications

  Within 3 months after operation

Study Arms (3)

Group I

ACTIVE COMPARATOR

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

Drug: intravenous application of tranexamic acid; Drug: Floseal hemostatic matrix

Group II

ACTIVE COMPARATOR

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

Drug: intravenous application of tranexamic acid

Group III

PLACEBO COMPARATOR

Control group, neither TXA nor Floseal® will be used. Equivalent volume of normal saline injection pre- and post-operatively

Drug: Normal saline

Interventions

intravenous application of tranexamic acid DRUG

intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later.

Also known as: transamine

Group I; Group II

Floseal hemostatic matrix DRUG

application of Floseal® on potential bleeding sites after prosthesis implantation

Also known as: Floseal

Group I

Normal saline DRUG

Equivalent volume of saline injection before incision, followed by two boluses (1g TXA) three hours later and six hours later.

Also known as: saline

Group III

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age \> 18 years and \< 90 years
• Failure of medical treatment or rehabilitation.
• Hemoglobin \> 11g/dl,
• No use of non-steroid anti-inflammatory agent one week before operation

You may not qualify if:

• Preoperative Hemoglobin ≦11 g/dl
• History of infection or intraarticular fracture of the affective hip
• Renal function deficiency (GFR \<30 ml/min/1.73m2)
• 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)
• History of deep vein thrombosis, ischemic heart disease or stroke
• Contraindications of tranexamic acid, floseal, or rivaroxaban
• Allergy to tranexamic acid, floseal, rivaroxaban, or the excipients
• History of heparin-induced thrombocytopenia (HIT)
• Coagulopathy or bleeding tendency caused by organ dysfunction, such as cirrhosis, bone marrow suppression etc.
• Patient who have active bleeding disorder, such as intracranial hemorrhage, upper gastrointestinal bleeding, hematuria.
• Patients with known allergies to materials of bovine origin.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Postoperative Hemorrhage

Interventions

Tranylcypromine; FloSeal Matrix; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jun-Wen Wang, MD

  Chang Gung Memorial Hospital

  STUDY CHAIR

Central Study Contacts

Jun-Wen Wang, MD

CONTACT

886-7-7317123; wangjw@adm.cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 9, 2018
• Study Start: August 15, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

TW (1)