Pneumatic Tourniquet Versus no Tourniquet in Transfemoral Amputation - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Total blood loss calculated using Nadler's approach
研究概览
简要总结
Lower extremity amputation patients represent a frail group of patients with extensive comorbidity. The most common indication of amputation is ischemia, infection and concomitant ischemic pain due to underlying chronic disease, especially arteriosclerosis and diabetes.
Prolonged general anesthesia and surgery as well as increased blood loss may result in impaired patient safety. Previous studies have shown total blood loss approx. 1000 mL in transfemoral amputations (TFA). Substantial blood loss during surgery increases the risk of anemic complications and death for this already weakened patient group.
The aim of this randomized controlled trial is to improve patient safety by exploring the possibility of a more precautious surgical procedure for TFA. Hence, investigating the total blood loss and secondary differences in complications after TFA between patients operated with use of pneumatic tourniquet versus no tourniquet. Total blood loss is calculated via Nadlers approach. From a pilot series, sample size was calculated to 124, allocated 1:1 in two groups of 62 participants, to ensure detection of at least 200 mL difference in total blood loss.
The hypothesis is that use of tourniquet will decrease the total blood loss, the amount of blood transfusions, time of surgery and complications related to postoperative anemia without a higher rate of adverse events. The secondary and explorative outcomes are blood transfusions, intraoperative blood loss, length of stay, time of surgery, risk of readmission, risk of re-operation, risk of mortality, complications during admission, quality of life (QoL), prosthesis use and the prosthesis-specific survey Prothesis Evaluation Questionnaire (PEQ). QoL is measured with the validated questionnaire EQ-5D-5L preoperatively, and at 3, 6, and 12 months postoperatively.
The possibility to enhance patient safety is highly relevant, and this trial will aid in establishing evidence-based guidelines for TFA surgery.
详细描述
Hypothesis The hypothesis is that the use of tourniquet in Transfemoral amputation (TFA) surgery will reduce the total blood loss, the intraoperative blood loss and the need for blood transfusion post-operatively and thereby improve patient safety.
Aim Primary to investigate total blood loss and secondary to investigate differences in complications after TFA surgery between patients operated with use of pneumatic tourniquet versus no tourniquet.
Trial design overview Design: Randomized, prospective, blinded, two-arm, single center trial. Superiority-design. Group 1: Transfemoral amputation performed with tourniquet application Group 2: Transfemoral amputation performed without tourniquet application Population: Patients with indication for primary transfemoral amputation (intact femoral bone). Period: Expected trial inclusion period is October 2022- September 2024. Place: Odense University Hospital (OUH), Odense, Denmark Sample size: 62 in each group, a total of 124 participants inclusive a 20 % buffer.
The flow of TFA patients in the department is approximately 100 patients annually and it will therefore be possible to include the calculated sample size in the time frame available for this trial.
Tourniquet: The tourniquet that is used at OUH is FastAir® distributed and imported by Universal Medical Supplies Aps. Universal Medical Supplies Aps is not a part of this protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Blinding Participants and staff not attendant in the room will be blinded. The use of tourniquet will not be visible in the patient records but recorded directly in the REDCap Database. A standard phrase to describe the surgical procedure will be used in the patient record. Deviations and adverse events will be described. Participants will be able to be informed by the procedure after 6 months.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Speak and understand Danish and able to give informed consent
- •≥18 years of age
- •Indication for first transfemoral amputation (intact femur)
排除标准
- •Bilateral amputation in same procedure
- •Femoral amputation revision (non-intact femur)
- •Malignant disease as main cause of amputation
- •Not possible to place tourniquet correctly (surgeon assessment)
- •Acute trauma
- •Planned surgery with surgeon charged less than second year residents.
结局指标
主要结局
Total blood loss calculated using Nadler's approach
时间窗: Day 1- Day3
To calculate this outcome the following information is needed: gender, weight, height, hemoglobin value before surgery (accepted timespan 4 weeks before surgery to day of surgery), hemoglobin value on the third day post surgery, and the number of blood transfusions (from day of surgery to third postoperative day).
次要结局
- Intraoperative blood loss(Day 1)
- Risk of mortality ≤30 days(Day 1 - Day 30)
- Risk of re-operation ≤30 days and ≤90 days(Day 1- Day 90)
- Risk of readmission ≤90 days(Day 1 - Day 90)
- Blood transfusion(Day 1- Day 3)
- Complications during admission(Day 1 - To Discharge or date of death, whichever comes first, with a maxium of 52 weeks)
- Length of stay(Day 1 - To discharge or date of death, whichever comes first, with a maxium of 52 weeks)
研究者
Anna Trier Heiberg Brix
Medical Doctor, PhD Student
University of Southern Denmark