- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04042688
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 08308
- Korea University Guro Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- primary single bundle anterior cruciate ligament reconstruction using a hamstring autograft with or without meniscus surgeries
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment group
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
|
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.
|
NO_INTERVENTION: Control gorup
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
extent of pain
Time Frame: 1 day and 5days
|
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.
|
1 day and 5days
|
patellar circumference
Time Frame: 2days and 5days
|
The patellar circumference was measured transverse axis of the patella center to evaluate intra-articular effusion
|
2days and 5days
|
range of motion
Time Frame: 6 weeks
|
The range of motion was documented as the extension and flexion degrees using an orthopaedic goniometer.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jihoon Bae, Department of Orthopaedic Surgery at Korea University Guro Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Wounds and Injuries
- Hemorrhage
- Joint Diseases
- Musculoskeletal Diseases
- Pain, Postoperative
- Rupture
- Hemarthrosis
- Molecular Mechanisms of Pharmacological Action
- Fibrin Modulating Agents
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Tranexamic Acid
Other Study ID Numbers
- GR0011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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