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Status unknownNCT04855877Updated Jul 28, 2021

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

A Phase 4 interventional study of Oral tablet and Placebo in Hemorrhage Postoperative, Anterior Cruciate Ligament Rupture and Arthroscopy, sponsored by University of Liege. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-07-28.

Sponsored by University of Liege · Phase 4, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.

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Phase
Phase 4
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hemorrhage Postoperative
  • Anterior Cruciate Ligament Rupture
  • Arthroscopy
  • Total Blood Loss
03

In context

Postoperative Hemorrhage

135 studies on the registry are indexed under Postoperative Hemorrhage; 31 are open to participants now.

This study's planned enrollment of 104 is close to the median of 100 across 102 interventional studies indexed under Postoperative Hemorrhage.

Browse Postoperative Hemorrhage studies →

Lead sponsor

University of Liege is the lead sponsor of 251 studies on the registry; 50 are open to participants now.

Browse University of Liege studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primary arthroscopic surgery for anterior cruciate ligament reconstruction

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
104 participants (estimated)

Study arms

  • Active comparator
    Oral Tranexamic Acid

    52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy

    Drug: Oral tablet

  • Placebo comparator
    Placebo

    52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy

    Drug: Placebo

Interventions

  • DrugOral tablet

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

  • DrugPlacebo

    Oral administration of lactose tablet (placebo)

06

What researchers measure

Primary outcomes

  1. Assessment of haemarthrosis

    Postoperative (drainage) blood loss

    Time frame: First 24 hours after surgery

Secondary outcomes

  1. Postoperative pain

    Postoperative pain score on numeric ratio scale (NRS) from 0 (no pain) to 10 (worst pain)

    Time frame: 24 hours after surgery

  2. Postoperative pain

    Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)

    Time frame: 72 hours after surgery

  3. Postoperative pain

    Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)

    Time frame: 7 days after surgery

  4. Postoperative pain

    Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)

    Time frame: 15 days after surgery

  5. Clinical evaluation of functional recovery

    Tegner activity score from 0 (no activity) to 10 (competitive sport)

    Time frame: 1 days after surgery

  6. Clinical evaluation of functional recovery

    Tegner activity score from 0 (no activity) to 10 (competitive sport)

    Time frame: 3 days after surgery

  7. Clinical evaluation of functional recovery

    Tegner activity score from 0 (no activity) to 10 (competitive sport)

    Time frame: 7 days after surgery

  8. Clinical evaluation of functional recovery

    Tegner activity score from 0 (no activity) to 10 (competitive sport)

    Time frame: 15 days after surgery

  9. Length of hospital stay

    Total days of hospitalization

    Time frame: First 30 days after surgery

07

Study locations

1 of 1 sites recruiting
  • CHU de Liège
    Liège, 4000, Belgium
    Recruiting
    • Michele Carella, MD · Contact003242843658
08

References and documents

Publications

  • 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. PubMed 30640647 ↗
  • 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. PubMed 32168220 ↗
  • 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. PubMed 26337246 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2021 (actual). Primary completion is estimated for Jun 2023, 22 months after the start.

Of 13 phase 4 interventional studies under Postoperative Hemorrhage, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 23. This study's planned 22 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 20, 2021
First posted
Apr 22, 2021
StartActual
Jul 6, 2021
Primary completionEst.
Jun 1, 2023
CompletionEst.
Jul 1, 2023
Last update
Jul 28, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04855877
Lead sponsor
University of Liege
Responsible party
Jean François Brichant (Head of Anesthesiology Departement, University of Liege) — Principal investigator
First posted
Apr 22, 2021
Start date
Jul 6, 2021
Primary completion
Jun 1, 2023 (estimated)
Completion
Jul 1, 2023 (estimated)
Last update
Jul 28, 2021

Study contacts

Nicolas Piette, MD
Contact
piettenicolas@me.com
003242843824

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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