Anterior Cruciate Ligament RupturePhase 4NCT04042688
Intra-articular Administration of 3.0g Tranexamic Acid Has no Effect on Reducing Intra-articular Hemarthrosis and Postoperative Pain After Primary Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
A Phase 4 study testing intraarticular administration of tranexamic acid in people with Anterior Cruciate Ligament Rupture, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
The purpose of this study was to investigate whether intraarticular administration of tranexamic acid could reduce hemarthrosis and postoperative pain in patients following anterior cruciate ligament reconstruction. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- intraarticular administration of tranexamic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2017to 30 Aug 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- primary single bundle anterior cruciate ligament reconstruction using a hamstring autograft with or without meniscus surgeries
Who cannot join
- use of other grafts (allograft, bone patellar tendon bone autograft)
- revision anterior cruciate ligament reconstruction,
- concomitant knee cartilage or collateral ligament surgeries
- history of knee surgery on affected knee
- concomitant fracture
- significnat preoperative pain (Visual analoge score >5)
- coagulation or bleeding disorders
- preoperative anticoagulation treatment
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to investigate whether intraarticular administration of tranexamic acid could reduce hemarthrosis and postoperative pain in patients following anterior cruciate ligament reconstruction. The hypothesis of the study was that patients treated with intraarticular tranexamic acid would have significantly less postoperative hemarthrosis and less pain in the early phase of the rehabilitation process compared with those without intraarticular tranexamic acid .
Read the detailed description
Intervention Based on the previous studies, intraarticular administration with concentration of 30mg/mL was selected. The operation room nurses prepared 3g tranexamic acid in 100 mL of saline solution during operation. After finishing surgical wound suture and orthopaedic surgeons related to this study left operation room, the orthopaedic residents who were not involved in the postoperative evaluation administered tranexamic acid solution through suprapatellar pouch before tourniquet release in patients in the treatment group. The control group did not receive any solution. intraarticular drain was not inserted in all patients.
Outcome Demographic variables (age, sex, body mass index, and time from injury to surgery), clinical outcomes and surgical records including operative time, bleeding amounts, meniscus and cartilage lesions were collected by an independent orthopaedic resident. Primary outcome was a blood loss calculated based on hemoglobin balance. We assumed that blood volume in ml on the second day after surgery was the same as that before surgery. Blood volume was estimated according to the method of Nadler and colleagues taking sex, body mass and height into account. The loss of Hemoglobin was then estimated according to the formula.
Hemoglobin loss=Blood volume*(Hemoglobin concentration before surgery - Hemoglobin concentration after surgery)*0.001+total amount of allogenic hemoglobin transfused
The secondary outcome was an extent of pain measured by a visual analog scale at a consistent time in the afternoon of postoperative day 1 (PD 1) and for the next 4 day.The pain visual analog scale is a numeric response on a scale from 0 to 10, with 0 denoting no pain and 10 signifying severe pain. The other secondary outcomes included mid-patellar circumference at postoperative day 2 and day 5 and knee range of motion after 6 weeks from operation, which were measured by an independent orthopaedic fellow. The patellar circumference was measured transverse axis of the patella center to evaluate intra-articular effusion. To minimize inter-observer variance of the patellar circumference, we considered the difference between the preoperative and the postoperative results. The range of motion was documented as the extension and flexion degrees using an orthopaedic goniometer.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- intraarticular administration of tranexamic acid
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraarticular administration of tranexamic acidDrug
Intraarticular administration with concentration of 30mg/mL was selected. The operation room nurses prepared 3g tranexamic acid in 100 mL of saline solution during operation. After finishing surgical wound suture and orthopaedic surgeons related to this study left operation room, the orthopaedic residents who were not involved in the postoperative evaluation administered tranexamic acid solution through suprapatellar pouch before tourniquet release in patients in the treatment group. The control group did not receive any solution. intraarticular drain was not inserted in all patients.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients were randomly allocated to one of two groups during preoperative preparation by computer-generated randomization. Treatment group; IA administration of TXA, control group; no TXA administration Receives: Drug: intraarticular administration of tranexamic acid |
| Control gorup | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss
Primary outcome was a blood loss calculated based on hemoglobin balance. We assumed that blood volume in ml on the second day after surgery was the same as that before surgery. Blood volume was estimated according to the method of Nadler and colleagues taking sex, body mass and height into account. The loss of Hemoglobin was then estimated according to the formula.
Hemoglobin loss=Blood volume*(Hemoglobin concentration before surgery - Hemoglobin concentration after surgery)*0.001+total amount of allogenic hemoglobin transfused.
Measured: 2 days
Secondary outcomes (3)
extent of pain
The secondary outcome was an extent of pain measured by a visual analog scale at a consistent time in the afternoon of postoperative day 1 and for the next 4 day.The pain visual analog scale is a numeric response on a scale from 0 to 10, with 0 denoting no pain and 10 signifying severe pain.
Measured: 1 day and 5days
patellar circumference
The patellar circumference was measured transverse axis of the patella center to evaluate intra-articular effusion
Measured: 2days and 5days
range of motion
The range of motion was documented as the extension and flexion degrees using an orthopaedic goniometer.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start1 Jul 2017
- Primary completion20 Jun 2019
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Hoon Bae, Korea University Guro Hospital
- Investigators
- Jihoon Bae, Principal investigator, Department of Orthopaedic Surgery at Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042688
- Sponsor's protocol ID
- GR0011
- Status last verified
- Aug 2019
- First submitted
- 1 Aug 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee JW, Kim SG, Kim SH, Cho HW, Bae JH. Intra-articular Administration of Tranexamic Acid Has No Effect in Reducing Intra-articular Hemarthrosis and Postoperative Pain After Primary ACL Reconstruction Using a Quadruple Hamstring Graft: A Randomized Controlled Trial. Orthop J Sports Med. 2020 Jul 22;8(7):2325967120933135. doi: 10.1177/2325967120933135. eCollection 2020 Jul.
PubMed 32743011
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Administration of 3.0g Tranexamic Acid Has no Effect on Reducing Intra-articular Hemarthrosis and Postoperative Pain After Primary Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04042688
- Acronym / sponsor ID
- GR0011
- Conditions
- Anterior Cruciate Ligament Rupture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to investigate whether intraarticular administration of tranexamic acid could reduce hemarthrosis and postoperative pain in patients following anterior cruciate ligament reconstruction. The hypothesis of the study was that patients treated with intraarticular tranexamic acid would have significantly less postoperative hemarthrosis and less pain in the early phase of the rehabilitation process compared with those without intraarticular tranexamic acid .
Detailed description
Intervention Based on the previous studies, intraarticular administration with concentration of 30mg/mL was selected. The operation room nurses prepared 3g tranexamic acid in 100 mL of saline solution during operation. After finishing surgical wound suture and orthopaedic surgeons related to this study left operation room, the orthopaedic residents who were not involved in the postoperative evaluation administered tranexamic acid solution through suprapatellar pouch before tourniquet release in patients in the treatment group. The control group did not receive any solution. intraarticular drain was not inserted in all patients.
Outcome Demographic variables (age, sex, body mass index, and time from injury to surgery), clinical outcomes and surgical records including operative time, bleeding amounts, meniscus and cartilage lesions were collected by an independent orthopaedic resident. Primary outcome was a blood loss calculated based on hemoglobin balance. We assumed that blood volume in ml on the second day after surgery was the same as that before surgery. Blood volume was estimated according to the method of Nadler and colleagues taking sex, body mass and height into account. The loss of Hemoglobin was then estimated according to the formula.
Hemoglobin loss=Blood volume*(Hemoglobin concentration before surgery - Hemoglobin concentration after surgery)*0.001+total amount of allogenic hemoglobin transfused
The secondary outcome was an extent of pain measured by a visual analog scale at a consistent time in the afternoon of postoperative day 1 (PD 1) and for the next 4 day.The pain visual analog scale is a numeric response on a scale from 0 to 10, with 0 denoting no pain and 10 signifying severe pain. The other secondary outcomes included mid-patellar circumference at postoperative day 2 and day 5 and knee range of motion after 6 weeks from operation, which were measured by an independent orthopaedic fellow. The patellar circumference was measured transverse axis of the patella center to evaluate intra-articular effusion. To minimize inter-observer variance of the patellar circumference, we considered the difference between the preoperative and the postoperative results. The range of motion was documented as the extension and flexion degrees using an orthopaedic goniometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: intraarticular administration of tranexamic acidPatients were randomly allocated to one of two groups during preoperative preparation by computer-generated randomization. Treatment group; IA administration of TXA, control group; no TXA administration |
| Control gorup | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- primary single bundle anterior cruciate ligament reconstruction using a hamstring autograft with or without meniscus surgeries
Key exclusion criteria (8 listed)
- use of other grafts (allograft, bone patellar tendon bone autograft)
- revision anterior cruciate ligament reconstruction,
- concomitant knee cartilage or collateral ligament surgeries
- history of knee surgery on affected knee
- concomitant fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraarticular administration of tranexamic acidIntraarticular administration with concentration of 30mg/mL was selected. The operation room nurses prepared 3g tranexamic acid in 100 mL of saline solution during operation. After finishing surgical wound suture and orthopaedic surgeons related to this study left operation room, the orthopaedic residents who were not involved in the postoperative evaluation administered tranexamic acid solution through suprapatellar pouch before tourniquet release in patients in the treatment group. The control group did not receive any solution. intraarticular drain was not inserted in all patients. | Drug | Treatment group |
Primary outcome
blood loss
Time frame: 2 days
Primary outcome was a blood loss calculated based on hemoglobin balance. We assumed that blood volume in ml on the second day after surgery was the same as that before surgery. Blood volume was estimated according to the method of Nadler and colleagues taking sex, body mass and height into account. The loss of Hemoglobin was then estimated according to the formula. Hemoglobin loss=Blood volume*(Hemoglobin concentration before surgery - Hemoglobin concentration after surgery)*0.001+total amount of allogenic hemoglobin transfused.
3 secondary outcomes
extent of pain
Time frame: 1 day and 5days
patellar circumference
Time frame: 2days and 5days
range of motion
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Derived from this study: PubMed 32743011Lee JW, Kim SG, Kim SH, Cho HW, Bae JH. Intra-articular Administration of Tranexamic Acid Has No Effect in Reducing Intra-articular Hemarthrosis and Postoperative Pain After Primary ACL Reconstruction Using a Quadruple Hamstring Graft: A Randomized Controlled Trial. Orthop J Sports Med. 2020 Jul 22;8(7):2325967120933135. doi: 10.1177/2325967120933135. eCollection 2020 Jul.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jihoon Bae principal investigator
Department of Orthopaedic Surgery at Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intraarticular administration of tranexamic acid in people with Anterior Cruciate Ligament Rupture, run by Korea University Guro Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood loss (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04042688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.