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Trial record 84 of 419 for:    TRANEXAMIC ACID

Intraarticular Injection of Tranexamic Acid Reduced Postoperative Hemarthrosis in Arthroscopic Anterior Cruciate Ligament Reconstruction

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ClinicalTrials.gov Identifier: NCT03580018
Recruitment Status : Completed
First Posted : July 9, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief Summary:
Post-anterior cruciate ligament reconstruction (ACLR) hemarthrosis may result in increased pain thus delaying postoperative rehabilitation, which may eventually lead to arthrofibrosis and a functional deficit. Many antifibrinolytic agents, including tranexamic acid (TXA), have been used in orthopedic surgeries to reduce postoperative bleeding.The purpose of this study is to evaluate the effect of intra-articular injection of TXA in patients receiving arthroscopic ACLRs. Patients were randomized into two groups. Group 1 patients (TXA group) received the index procedures with a 10 mL intra-articular injection of TXA. Group 2 (control group) patients received the index procedures without TXA injections. An intra-articular suction drain was placed recorded 24 h postoperatively. Clinical evaluations using an IKDC functional score, range of motion (ROM), and a Visual Analogue Scale (VAS) pain score were performed at postoperative day 3 and week 4.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Reconstruction Drug: Tranexamic Acid Powder Procedure: Post-anterior cruciate ligament reconstruction (ACLR) Not Applicable

Detailed Description:

TXA group patients received ACLRs and a 10 mL intra-articular injection of TXA after the procedure. The control group patients only received ACLRs without TXA injections. Randomization was done on the day of the surgery, by an independent investigator who did not participate in the surgery, using the permuted block randomization technique.

The same surgeon treated all patients enrolled in this study. Spinal anesthesia was given to all patients and a pneumatic tourniquet was routinely used. In brief, through a 3 cm incision over the medial proximal tibia, semitendinosus (ST) and gracilis (Gr) tendons were harvested from the distal insertion. Tendons were quadrupled and whip stitched by No. 2 and No. 5 Ethibond sutures (Ethicon, Somerville, NJ). The diameters of the folded tendons were determined by using sizing cylinders with incremental size changes of 0.5 mm.The femoral sockets were created at about the 1:30 position (left knee), through the anteromedial portal. The tibial tunnel was created with an ACUFEX guide (Smith & Nephew, Andover, MA). The diameters of the socket were created in the same manner as the diameter of the folded graft. At tibial site, grafts were fixed with bioscrews (BIORCI-HA, Smith & Nephew) at 30 degrees of knee flexion. The screw and the tunnel sizes were the same. After completion of the procedure, a suction drain (Zimmer HEMOVAC, Warsaw, IN) was placed at the superior lateral aspect of the joint. Ten mL of TXA (100 mg/mL) (Daiichi Sankyo, Tokyo, Japan) was injected into the joint at the end of the operation and the drain was clamped for 2 h.

Clinical evaluations The volume of drainage was recorded 24 h after surgery. The grade of hemarthrosis, as previously described by Coupens et al.,was also documented at day 3 and week The range of knee motion and the IKDC functional score were evaluated 4 weeks post-surgery. The VAS was documented at postoperative day 3 and week 4.

Statistical analysis. All data are expressed as a mean and standard deviation (SD). The amount of drainage or functional scores between different groups were compared with an independent t test.

All statistical analyses were conducted using SPSS version 11.0 (SPSS Inc., Chicago,IL). Differences were considered significant when the p-value was < 0.05.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intraarticular Injection of Tranexamic Acid Reduced Postoperative Hemarthrosis in Arthroscopic Anterior Cruciate Ligament Reconstruction - A Prospective Randomized Study
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tranexamic Acid group
Ten mL of TXA (100 mg/mL) was injected into the joint at the end of the index operation and the drain was clamped for 2 h.
Drug: Tranexamic Acid Powder
Ten mL of Tranexamic Acid(100 mg/mL) was injected into the joint at the end of the operation.

Placebo Comparator: Control Group
The control group patients only received ACLRs without TXA injections.
Procedure: Post-anterior cruciate ligament reconstruction (ACLR)
Post-anterior cruciate ligament reconstruction (ACLR)




Primary Outcome Measures :
  1. The volume of drainage [ Time Frame: 24 hours after surgery. ]
    hemoarthrosis


Secondary Outcome Measures :
  1. The grade of hemarthrosis [ Time Frame: At day 3 and week 4. ]
    Grade I to IV.

  2. The VAS was documented [ Time Frame: Postoperative day 3 and week 4. ]
    scale 0 to 10.

  3. IKDC functional score [ Time Frame: Evaluated 4 weeks post-surgery. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patient agreed to participate in this study, signed an informed consent document.
  2. patients receiving arthroscopic ACLR with autologous hamstring grafts

Exclusion Criteria:

  1. previous knee procedures on the same side
  2. renal disorder or insufficiency
  3. abnormal coagulation profile
  4. refused to participate in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580018


Locations
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Taiwan
Hsiao-Li
Taipei, Taiwan, 11217
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03580018     History of Changes
Other Study ID Numbers: 2017-07-004B
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Veterans General Hospital, Taiwan:
Anterior cruciate ligament reconstruction, knee, hemarthrosis, tranexamic acid
Additional relevant MeSH terms:
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Tranexamic Acid
Hemarthrosis
Joint Diseases
Musculoskeletal Diseases
Hemorrhage
Pathologic Processes
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants