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

January 16, 2020 updated by: Wang Jun-Wen, Chang Gung Memorial Hospital

Blood-saving Effect of Combined Intravenous Tranexamic Acid With Topical Floseal® Application, a Comparison With Intravenous Tranexamic Acid Only in Total Hip Arthroplasty

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I
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
intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later.
Other Names:
  • transamine
Drug: Floseal hemostatic matrix
application of Floseal® on potential bleeding sites after prosthesis implantation
Other Names:
  • Floseal
Active Comparator: Group II
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
intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later.
Other Names:
  • transamine
Placebo Comparator: Group III
Control group, neither TXA nor Floseal® will be used. Equivalent volume of normal saline injection pre- and post-operatively
Drug: Normal saline
Equivalent volume of saline injection before incision, followed by two boluses (1g TXA) three hours later and six hours later.
Other Names:
  • saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Blood Loss
Time Frame: 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
Post op day 4
Acute intraoperative Blood Loss
Time Frame: 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)
At the end of operation
The change of Hemoglobin level
Time Frame: Preoperative day 1 to Post op day 4
Check postoperative Hemoglobin level on postoperative day 1,2,4
Preoperative day 1 to Post op day 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood transfusion rate
Time Frame: Within 3 months after operation
We will record the event of blood transfusion, and calculate the incidence of transfusion
Within 3 months after operation
Thrombosis risk evaluation
Time Frame: Within 3 months after operation
Detect the presence of deep-vein thrombosis of both lower limbs by duplex ultrasound study before discharge
Within 3 months after operation
Incidence of wound complications
Time Frame: Within 3 months after operation
Wound complications including hematoma, skin necrosis and infection
Within 3 months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2018

Primary Completion (Anticipated)

July 31, 2020

Study Completion (Anticipated)

July 31, 2020

Study Registration Dates

First Submitted

August 1, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 16, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201701718A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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