NCT04855877

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 6, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

1.9 years

First QC Date

April 20, 2021

Last Update Submit

July 27, 2021

Conditions

Hemorrhage PostoperativeAnterior Cruciate Ligament RuptureArthroscopyTotal Blood Loss

Outcome Measures

Primary Outcomes (1)

  • Assessment of haemarthrosis

    Postoperative (drainage) blood loss

    First 24 hours after surgery

Secondary Outcomes (9)

  • Postoperative pain

    24 hours after surgery

  • Postoperative pain

    72 hours after surgery

  • Postoperative pain

    7 days after surgery

  • Postoperative pain

    15 days after surgery

  • Clinical evaluation of functional recovery

    1 days after surgery

  • +4 more secondary outcomes

Study Arms (2)

Oral Tranexamic Acid

ACTIVE COMPARATOR

52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy

Drug: Oral tablet

Placebo

PLACEBO COMPARATOR

52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy

Drug: Placebo

Interventions

Oral tabletDRUG

Oral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration

Oral Tranexamic Acid
PlaceboDRUG

Oral administration of lactose tablet (placebo)

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary arthroscopic surgery for anterior cruciate ligament reconstruction

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Liège

Liège, 4000, Belgium

RECRUITING

Related Publications (3)

  • 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.

    PMID: 30640647BACKGROUND

  • 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.

    PMID: 32168220BACKGROUND

  • 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.

    PMID: 26337246BACKGROUND

MeSH Terms

Conditions

Postoperative HemorrhageAnterior Cruciate Ligament InjuriesExsanguination

Interventions

Tablets

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative ComplicationsKnee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Central Study Contacts

Nicolas Piette, MD

CONTACT

003242843824piettenicolas@me.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Patient, anesthesiologist and surgeon are blinded
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Double blinded prospective randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesiology Departement

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 22, 2021

Study Start

July 6, 2021

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

July 28, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)