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Noninferiority Oral Tranexamic Acid vs Intravenous Administration in Total Hip Arthroplasty

Primary Purpose

Hemorrhage Postoperative, Total Blood Loss, Arthroplasty Complications

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Tranexamic Acid Oral Product
Tranexamic acid injection
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemorrhage Postoperative

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- ASA physical status 1, 2 and 3 scheduled for primary total hip arthroplasty

Exclusion Criteria:

  • Renal failure with serum creatinine level higher than 1,40 mg/dL
  • Thromboembolic events in last 12 months before surgery
  • Pregnancy
  • Congenital or acquired coagulation diseases
  • History of gastric surgery that could lead to malabsorption
  • Diabetic gastro-paresis

Sites / Locations

  • CHU de Liège

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Oral Tranexamic Acid

Intravenous Tranexamic Acid

Arm Description

128 patients scheduled for primary total hip arthroplasty

128 patients scheduled for primary total hip arthroplasty

Outcomes

Primary Outcome Measures

Total blood loss
Peroperative (suction) and postoperative (drainage) total blood loss

Secondary Outcome Measures

Serum concentration of tranexamic acid
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Serum concentration of tranexamic acid
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Serum concentration of tranexamic acid
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Serum concentration of tranexamic acid
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Serum hemoglobin variation
Variation of serum hemoglobin between preoperative and postoperative period
Serum hemoglobin variation
Variation of serum hemoglobin between preoperative and postoperative period
Incidence of blood transfusion
Incidence of blood transfusion in two groups
Incidence of thromboembolic complications
Incidence of thromboembolic complications such as pulmonary embolism or deep venous thrombosis
Length of hospitalisation stay
Difference between two groups of total hospitalisation days

Full Information

First Posted
December 29, 2020
Last Updated
December 14, 2022
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT04691362
Brief Title
Noninferiority Oral Tranexamic Acid vs Intravenous Administration in Total Hip Arthroplasty
Official Title
Study of the Noninferiority of an Oral vs Intravenous Administration of Tranexamic Acid in Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 14, 2022 (Actual)
Study Completion Date
December 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To find noninferiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss and serum concentration during primary total hip arthroplasty.
Detailed Description
Tranexamic acid is an anti-fibrinolytic drug, recommended in total hip arthroplasty to reduce peroperative and postoperative hemorrhagic complications. The original character of our study lies in the serum dosage of tranexamic acid, allowing to correlate the primary objective (blood loss) with this one. The investigators will focus on the reduction of the risks associated with the administration of intravenous medicines, the economic aspect and the ease of use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage Postoperative, Total Blood Loss, Arthroplasty Complications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blinded randomized controlled trial. Patient, anesthesiologist and surgeon are blinded.
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Tranexamic Acid
Arm Type
Active Comparator
Arm Description
128 patients scheduled for primary total hip arthroplasty
Arm Title
Intravenous Tranexamic Acid
Arm Type
Active Comparator
Arm Description
128 patients scheduled for primary total hip arthroplasty
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid Oral Product
Intervention Description
Oral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid injection
Intervention Description
Intravenous administration of 1 gramme tranexamic acid 30 minutes before skin incision and 1 gramme intravenous tranexamic acid 4 hours after first administration
Primary Outcome Measure Information:
Title
Total blood loss
Description
Peroperative (suction) and postoperative (drainage) total blood loss
Time Frame
First 48 hours after surgery
Secondary Outcome Measure Information:
Title
Serum concentration of tranexamic acid
Description
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Time Frame
2 hours after oral administration
Title
Serum concentration of tranexamic acid
Description
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Time Frame
6 hours after oral administration
Title
Serum concentration of tranexamic acid
Description
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Time Frame
30 minutes after intravenous administration
Title
Serum concentration of tranexamic acid
Description
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Time Frame
4 hours after intravenous administration
Title
Serum hemoglobin variation
Description
Variation of serum hemoglobin between preoperative and postoperative period
Time Frame
24 hours after surgery
Title
Serum hemoglobin variation
Description
Variation of serum hemoglobin between preoperative and postoperative period
Time Frame
72 hours after surgery
Title
Incidence of blood transfusion
Description
Incidence of blood transfusion in two groups
Time Frame
72 hours after surgery
Title
Incidence of thromboembolic complications
Description
Incidence of thromboembolic complications such as pulmonary embolism or deep venous thrombosis
Time Frame
72 hours after surgery
Title
Length of hospitalisation stay
Description
Difference between two groups of total hospitalisation days
Time Frame
1 week after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - ASA physical status 1, 2 and 3 scheduled for primary total hip arthroplasty Exclusion Criteria: Renal failure with serum creatinine level higher than 1,40 mg/dL Thromboembolic events in last 12 months before surgery Pregnancy Congenital or acquired coagulation diseases History of gastric surgery that could lead to malabsorption Diabetic gastro-paresis
Facility Information:
Facility Name
CHU de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30640647
Citation
Fillingham YA, Ramkumar DB, Jevsevar DS, Yates AJ, Bini SA, Clarke HD, Schemitsch E, Johnson RL, Memtsoudis SG, Sayeed SA, Sah AP, Della Valle CJ. Tranexamic acid in total joint arthroplasty: the endorsed clinical practice guides of the American Association of Hip and Knee Surgeons, American Society of Regional Anesthesia and Pain Medicine, American Academy of Orthopaedic Surgeons, Hip Society, and Knee Society. Reg Anesth Pain Med. 2019 Jan;44(1):7-11. doi: 10.1136/rapm-2018-000024. No abstract available.
Results Reference
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PubMed Identifier
30312799
Citation
Wu Y, Zeng Y, Hu Q, Li M, Bao X, Zhong J, Shen B. Blood loss and cost-effectiveness of oral vs intravenous tranexamic acid in primary total hip arthroplasty: A randomized clinical trial. Thromb Res. 2018 Nov;171:143-148. doi: 10.1016/j.thromres.2018.10.006. Epub 2018 Oct 6.
Results Reference
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Noninferiority Oral Tranexamic Acid vs Intravenous Administration in Total Hip Arthroplasty

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