Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 12
- 主要终点
- Visual Analog Scale
研究概览
简要总结
This is a prospective, multi-center, randomized, double-blind, placebo-controlled trial evaluating the efficacy of oral tranexamic acid (TXA) in improving postoperative outcomes following anterior cruciate ligament reconstruction (ACLR) using patellar tendon autograft in adolescent and young adult patients.
A total of 100 patients, aged 14 to 22 years and undergoing eligible ACLR, will be enrolled across multiple participating sites. Eligible participants will be randomized 1:1 to receive either oral TXA (1.95 g per day, divided into three 650 mg capsules) or placebo (microcrystalline cellulose) once daily from postoperative day 1 to 10, in addition to standard intraoperative care. All participants will receive 1 g IV TXA prior to incision and 1 g IV TXA at closure, per standard surgical protocol.
The primary outcome is improvement in postoperative pain, as measured by the Visual Analog Scale (VAS). Secondary outcomes are knee range of motion, quadriceps strength, isokinetic strength, time to straight leg raise, time to return to sport, International Knee Documentation Committee score, Lyshom score, and morphine milligram equivalents. Participants will be followed through routine postoperative visits at the participating institutions out to one year with a phone call for patient reported outcomes at 2 years.
详细描述
This multi-center, prospective, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the effect of oral tranexamic acid (TXA) on postoperative outcomes following anterior cruciate ligament reconstruction (ACLR) using bone-tendon-bone (BTB) autograft in adolescent and young adult patients.
Background:
Tranexamic acid is a synthetic antifibrinolytic agent that competitively inhibits plasminogen activation, helping to reduce bleeding. IV TXA is routinely used during orthopedic procedures, including ACLR, and has been shown to reduce intraoperative blood loss. However, the benefit of extending antifibrinolytic coverage with oral TXA in the early postoperative period has not been well studied in this population. This trial aims to investigate whether a 10-day postoperative course of oral TXA improves pain and recovery outcomes following ACLR.
Study Design:
Participants will be randomized in a 1:1 ratio to receive either oral TXA or a placebo. Randomization will be conducted using computer-generated allocation. Both the participants and the study team will remain blinded to group assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •14-22 year old individuals with ACL tear undergoing primary ACLR with patellar tendon autograft.
- •Closed or closing proximal tibial and distal femoral physes on pre-operative radiographs (less than one year of growth remaining based on MRI and radiographic bone age assessment)
- •Fluent in English
- •Willing to participate
- •Patient weight greater than or equal to 100lbs (45.4kg)
排除标准
- •Revision ACLR, multi-ligamentous knee reconstruction, inclusion of lateral extra-articular tenodesis (LET) or Anterolateral Ligament (ALL) reconstruction
- •Concomitant meniscal repair or chondral preservation surgery requiring postoperative limited weightbearing status (nonweightbearing or partial weightbearing)
- •Have a prior history of deep vein thrombosis (DVT) or thromboembolic event
- •Known allergy or hypersensitivity to TXA
- •Using combination hormonal contraception
研究组 & 干预措施
Oral TXA
Participants in this arm will receive oral tranexamic acid (TXA), 1.95 g daily (three 650 mg capsules) from POD 1 to POD 10, for a total of 10 doses (30 capsules). All participants will also receive 1 g IV TXA before incision and 1 g IV TXA at surgical closure as part of standard care.
干预措施: Tranexamic Acid (TXA) (Drug)
Placebo
Participants in this arm will receive oral placebo capsules (microcrystalline cellulose), 3 capsules daily from postoperative day (POD) 1 to POD 10, for a total of 10 doses (30 capsules). All participants will also receive 1 g IV TXA before incision and 1 g IV TXA at surgical closure as part of standard care.
干预措施: Placebo (Drug)
结局指标
主要结局
Visual Analog Scale
时间窗: Pre-op and 2 week, 6 week, 12 week, 6 months, 1 year, 2 year post op
The Visual Analog Scale (VAS) is a validated patient-reported outcome measure used to assess pain intensity. Patients rate their pain on a scale from 0 (no pain) to 10 (worst imaginable pain).
次要结局
- Knee Range of Motion(Pre-op and 2-week, 6-week, 12-week, 6 months, 1-year post-op)
- Quadriceps Strength(Pre-op and 2-week, 6-week, 12-week, 6 months, 1-year post-op)
- Isokinetic Strength(6 months, 9 months, 1-year post-op)
- Time to Straight Leg Raise(Up to 1 year)
- Time to Return to Sport(Up to 1 year)
- International Knee Documentation Committee Score(Pre-op and 6 months, 1-year, 2-years post-op)
- Lysholm Knee Score(Pre-op and 6 months, 1-year, 2-years post-op)
- Morphine Milligram Equivilants(2 weeks following surgery)
研究者
Frederick Azar
Chief of Staff
Campbell Clinic