2026-526142-27-01招募中3 期
Tranexamic Acid in Hind and Midfoot Arthrodesis Surgery: A Multicentre, Randomized, Placebo-Controlled Trial (TRASH Trial)
HUS-yhtymae3 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2026年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 3
- 主要终点
- Primary endpoint is a composite measure that combines superficial and deep SSIs up to one year. We will use the Centers for Disease Control and Prevention (CDC) definitions for SSI and categorise the infections as either superficial or deep.
研究概览
简要总结
To evaluate the effect of intraoperative tranexamic acid on postoperative infection rates after mid- and hindfoot arthrodesis at one year
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •A foot and ankle orthopedic surgeon has determined that the patient is suitable for a hind- or midfoot arthrodesis procedure
- •Ability to understand trial information and answer outcome assessments in Finnish or in Swedish
排除标准
- •Acute trauma
- •Documented hypercoagulable disorder (inherited or acquired)
- •History of seizures
- •History of local bone or joint infection in the past 12 months
- •Active bacterial infection or ulcer of the lower limb
- •Diabetes mellitus and glycohaemoglobin (GHb-A1C > 64mmol/l)
- •Patients with severe circulatory disorder of the lower limb, absence of palpable pulses in the foot
- •Patient unable to provide consent
结局指标
主要结局
Primary endpoint is a composite measure that combines superficial and deep SSIs up to one year. We will use the Centers for Disease Control and Prevention (CDC) definitions for SSI and categorise the infections as either superficial or deep.
Primary endpoint is a composite measure that combines superficial and deep SSIs up to one year. We will use the Centers for Disease Control and Prevention (CDC) definitions for SSI and categorise the infections as either superficial or deep.
次要结局
- Wound dehiscence is defined as either partial or total separation of the edges of previously approximated surgical wound with no signs of infection. The wound is assessed on at 2 weeks, 3 months and 12 months by a specialised nurse or a surgeon.
- Perioperative blood loss will be estimad by measuring haemoglobin levels on the day of surgery, both pre- and postoperatively, and reporting the absolute change in haemoglobin concentration (g/L).
- Cumulative revision surgery rate for any reason is reported up to 12 month follow-up. This includes any revision surgery performed in the operating room at the site of the initial surgery site.
- Fusion rate will be evaluated at the 12-month follow-up visit using a computed tomography scan. Arthrodesis will be considered fused if osseous bridging is observed as determined by the assessing radiologist.
- Exploratory endpoints will be collected and analysed, but the results will be evaluated separately: The Manchester–Oxford foot questionnaire (MOxFQ), Patient Acceptable Symptom State (PASS), Pain Numerical Rating Scale, Cost Effectiveness
研究者
Sami Kormi, MD, PhD Orthopaedic Surgeon, Department of Orthopaedics and Traumatology
Scientific
HUS-yhtymae
研究点 (3)
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