Tranexamic Acid Injection With Different Drainage Clamping Time After Anterior Cruciate Ligament Reconstruction

NCT06280456 | Completed

• 1 other identifier: 2023-09-017A
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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. Moreover, TXA was proved effective to reduced the events of hemarthrosis and increased the post-operative functional outcomes of the patients in several studies. The purpose of this study is to evaluate the efficacy of intra-articular injection of TXA with different drainage clamping time in patients receiving arthroscopic ACLRs. Patients were randomized into four groups. An intra-articular suction drain was placed recorded 24 h postoperatively. Group 1 patients(TXA 4hr group) received the index procedures with a 10 mL intra-articular injection of TXA and following drainage clamped 4 hours. Group 2 patients(TXA 8hr group) received the index procedures with a 10 mL intra-articular injection of TXA and following drainage clamped 8 hours. Clinical evaluations using an IKDC functional score and a Visual Analogue Scale (VAS) pain score were performed during admission, at postoperative day 3 and week 4.

Conditions

Anterior Cruciate Ligament Reconstruction; Tranexamic Acid; Hemarthrosis, Knee

Outcome Measures

Primary Outcomes (1)

• The volume of drainage

  hemarthrosis

  1 day (Total volume was recorded once the drain tube removed)

Secondary Outcomes (2)

• Visual analog scale (VAS)

  Immediately when back to the ward, maximum during admission, postoperative day 3 and week 4

• International Knee Documentation Committee (IKDC) functional score

  Evaluated 4 weeks post-surgery.

Study Arms (2)

Tranexamic Acid 4-hour group

EXPERIMENTAL

10 mL of TXA (100 mg/mL) was injected into the joint at the end of the index operation and the drain was clamped for 4 hours.

Drug: Tranexamic Acid Powder

Tranexamic Acid 8-hour group

EXPERIMENTAL

10 mL of TXA (100 mg/mL) was injected into the joint at the end of the index operation and the drain was clamped for 8 hours.

Drug: Tranexamic Acid Powder

Interventions

Tranexamic Acid Powder DRUG

10 mL of Tranexamic Acid(100 mg/mL) was injected into the joint at the end of the operation with different drainage clamping time.

Also known as: Daiichi Sankyo

Tranexamic Acid 4-hour group; Tranexamic Acid 8-hour group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving arthroscopic anterior cruciate ligament reconstruction with autologous hamstring grafts

You may not qualify if:

• previous knee procedure on the same side
• renal diseases
• coagulation disorder
• refusal of participation in the study

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hemarthrosis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• En-Rung Chiang

  Taipei Veterans General Hospital, Taiwan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: September 5, 2022
• Primary Completion: January 5, 2023
• Study Completion: February 5, 2023
• Last Updated: February 28, 2024

Record last verified: 2023-09

Locations

TW (1)