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Oral Administration of Tranexamic Acid in Anterior Cruciate Ligament Surgery Reduce Postoperative Haemarthrosis

Primary Purpose

Hemorrhage Postoperative, Anterior Cruciate Ligament Rupture, Arthroscopy

Status
Unknown status
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Oral tablet
Placebo
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 - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary arthroscopic surgery for anterior cruciate ligament reconstruction

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 LiègeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oral Tranexamic Acid

Placebo

Arm Description

52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy

52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy

Outcomes

Primary Outcome Measures

Assessment of haemarthrosis
Postoperative (drainage) blood loss

Secondary Outcome Measures

Postoperative pain
Postoperative pain score on numeric ratio scale (NRS) from 0 (no pain) to 10 (worst pain)
Postoperative pain
Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)
Postoperative pain
Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)
Postoperative pain
Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)
Clinical evaluation of functional recovery
Tegner activity score from 0 (no activity) to 10 (competitive sport)
Clinical evaluation of functional recovery
Tegner activity score from 0 (no activity) to 10 (competitive sport)
Clinical evaluation of functional recovery
Tegner activity score from 0 (no activity) to 10 (competitive sport)
Clinical evaluation of functional recovery
Tegner activity score from 0 (no activity) to 10 (competitive sport)
Length of hospital stay
Total days of hospitalization

Full Information

First Posted
April 20, 2021
Last Updated
July 27, 2021
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT04855877
Brief Title
Oral Administration of Tranexamic Acid in Anterior Cruciate Ligament Surgery Reduce Postoperative Haemarthrosis
Official Title
Does Oral Administration of Tranexamic Acid in Anterior Cruciate Ligament Arthroscopic Surgery Reduce Postoperative Haemarthrosis and Improve Functional Prognosis?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 6, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

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 superiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss, haemarthrosis prevalence and improvement functional prognosis in anterior cruciate ligament arthroscopy.
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, Anterior Cruciate Ligament Rupture, Arthroscopy, Total Blood Loss

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Oral Tranexamic Acid
Arm Type
Active Comparator
Arm Description
52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy
Intervention Type
Drug
Intervention Name(s)
Oral tablet
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)
Placebo
Intervention Description
Oral administration of lactose tablet (placebo)
Primary Outcome Measure Information:
Title
Assessment of haemarthrosis
Description
Postoperative (drainage) blood loss
Time Frame
First 24 hours after surgery
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
Postoperative pain score on numeric ratio scale (NRS) from 0 (no pain) to 10 (worst pain)
Time Frame
24 hours after surgery
Title
Postoperative pain
Description
Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)
Time Frame
72 hours after surgery
Title
Postoperative pain
Description
Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)
Time Frame
7 days after surgery
Title
Postoperative pain
Description
Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)
Time Frame
15 days after surgery
Title
Clinical evaluation of functional recovery
Description
Tegner activity score from 0 (no activity) to 10 (competitive sport)
Time Frame
1 days after surgery
Title
Clinical evaluation of functional recovery
Description
Tegner activity score from 0 (no activity) to 10 (competitive sport)
Time Frame
3 days after surgery
Title
Clinical evaluation of functional recovery
Description
Tegner activity score from 0 (no activity) to 10 (competitive sport)
Time Frame
7 days after surgery
Title
Clinical evaluation of functional recovery
Description
Tegner activity score from 0 (no activity) to 10 (competitive sport)
Time Frame
15 days after surgery
Title
Length of hospital stay
Description
Total days of hospitalization
Time Frame
First 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary arthroscopic surgery for anterior cruciate ligament reconstruction 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Piette, MD
Phone
003242843824
Email
piettenicolas@me.com
Facility Information:
Facility Name
CHU de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Carella, MD
Phone
003242843658

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
32168220
Citation
Muhunthan K, Balakumar S, Navaratnaraja TS, Premakrishna S, Arulkumaran S. Plasma Concentrations of Tranexamic Acid in Postpartum Women After Oral Administration. Obstet Gynecol. 2020 Apr;135(4):945-948. doi: 10.1097/AOG.0000000000003750.
Results Reference
background
PubMed Identifier
26337246
Citation
Karaaslan F, Karaoglu S, Yurdakul E. Reducing Intra-articular Hemarthrosis After Arthroscopic Anterior Cruciate Ligament Reconstruction by the Administration of Intravenous Tranexamic Acid: A Prospective, Randomized Controlled Trial. Am J Sports Med. 2015 Nov;43(11):2720-6. doi: 10.1177/0363546515599629. Epub 2015 Sep 2.
Results Reference
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Oral Administration of Tranexamic Acid in Anterior Cruciate Ligament Surgery Reduce Postoperative Haemarthrosis

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