Reducing Blood Loss in Hemipelvectomy Surgery With the Use Tranexamic Acid (TXA)
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Total perioperative blood loss defined as the total intraoperative estimation of blood (EBL) loss
研究概览
简要总结
This early phase I trial studies how well tranexamic acid works in reducing the loss of blood in patients with pelvic tumors undergoing hemipelvectomy surgery. Tranexamic acid decreases blood loss by stabilizing clots and preventing clot lysis in patients undergoing surgery.
详细描述
PRIMARY OBJECTIVES:
I. To determine if the use of tranexamic acid results in a significant reduction in intraoperative and perioperative blood loss.
SECONDARY OBJECTIVES:
I. To determine if use of tranexamic acid lowers the amount of blood products transfused in hemipelvectomy surgeries and during first postoperative week.
II. To determine if the use of tranexamic acid has an effect on laboratory (lab) measurements preoperatively through postoperative day 7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both pediatric and adult patients can be eligible to participate
- •Cognitively impaired and non-English speakers can be eligible to participate.
- •Both male and female patients must have a pelvic tumor and are scheduled to have surgery at University of Texas (UT) Monroe Dunaway (MD) Anderson Cancer center that require hemipelvectomy, resulting in pelvic ring disruption
排除标准
- •Patient with a history of genetic prothrombotic state
- •Patient with a history of thromboembolic disease to include pulmonary embolus or other extremity deep venous thrombosis
- •Patients with thrombosis of the planned site of resection will not be excluded if the thrombus is caused directly by tumor burden or outflow obstruction
- •Female patients will not be eligible for this study if she is either pregnant or nursing at the time of enrollment
- •Patients will not be eligible if they have a history of color vision defects
- •Patients will not be eligible if they have a history of retinal vein or artery occlusion
- •Patients will not be eligible if they have a history of intracranial hemorrhage in past 6 months
- •Patients will not be eligible if they have a history of hypersensitivity to tranexamic acid
- •Patients will not be eligible if they present with moderate to severe decrease in creatinine clearance (estimated glomerular filtration rate [eGFR] < 45 mL/min/1.73m2)
- •Patients will not be eligible if they present or have a history of seizure disorder
研究组 & 干预措施
Arm I (tranexamic acid)
Patients receive tranexamic acid IV over 15 minutes 30 minutes prior to surgery and continuously during hemipelvectomy procedure in the absence of disease progression or unacceptable toxicity.
干预措施: Hemipelvectomy (Procedure)
Arm I (tranexamic acid)
Patients receive tranexamic acid IV over 15 minutes 30 minutes prior to surgery and continuously during hemipelvectomy procedure in the absence of disease progression or unacceptable toxicity.
干预措施: Tranexamic Acid (Drug)
Arm II (no tranexamic acid)
Patients undergo standard of care hemipelvectomy in the absence of disease progression or unacceptable toxicity.
干预措施: Hemipelvectomy (Procedure)
结局指标
主要结局
Total perioperative blood loss defined as the total intraoperative estimation of blood (EBL) loss
时间窗: During first post-operative week
Intraoperative blood loss and perioperative blood loss (total of intraoperative EBL and 1 week drain) will be compared between two groups utilizing two-sample t-test or Wilcoxon rank-sum test. Log-transformation will be taken on the blood loss measurements as appropriate. Multivariable linear regression models will be used to compare two treatment groups in intraoperative and perioperative blood loss by adjusting for significant covariates. Model selection technique, including backward elimination, will be implemented.
次要结局
- Total number of units of packed red blood cells (PRBCs), fresh frozen plasma (FFP), cryoprecipitate, and platelets(At the time of procedure)
- Total number of units of PRBCs, FFP, cryoprecipitate, and platelets(During first post-operative week)
- Thromboelastography (TEG)(At baseline prior to administration of tranexamic acid, after completion of bone cuts, and after completion of closure)
- Change in laboratory measurements(Baseline up to 7 days post-surgery)
- Complications including but not limited to venous thromboembolism, stroke, seizure, vision changes, and return to operating room (hematoma, active bleeding)(Up to 7 days post-surgery)
- Length of ICU and hospital stay(Up to 7 days post-surgery)