Use of Tranexamic Acid for Prevention of Hemorrhage in Cesarean Delivery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Blood Volume Loss
研究概览
简要总结
The investigators prepared a novel study of tranexamic acid (TXA) designed to estimate the quantity of blood loss in women undergoing elective repeat cesarean deliveries. This is the first trial to utilize a prophylactic dose of TXA prior to incision followed by a subsequent prophylactic dose at placental delivery in obstetric patients undergoing scheduled cesareans. The purpose of this study is to quantify blood loss during uncomplicated repeat cesarean deliveries with and without TXA. The central hypothesis is that TXA administration reduces blood loss and fibrinolysis in women undergoing repeat cesarean sections.
详细描述
Obstetric hemorrhage has been identified as a contributory cause for the United States' suboptimal and inequitable outcomes among pregnant women. As such, obstetric hemorrhage has become a formal focus point in a national agenda to improve maternal outcomes. Strategies to identify maternal hypovolemia and treating obstetric hemorrhage are undergoing organized scrutiny in many states including Texas. Tranexamic acid (TXA) treatment is receiving increased emphasis in obstetric care because TXA inhibits fibrinolysis. Increased clot stability offers the possibility of preventing blood loss (prophylaxis) as well as mitigating ongoing hemorrhage. TXA therapy has been principally studied in nonpregnant populations; results of studies in pregnant women have been lacking.
Tranexamic acid is an antifibrinolytic agent that acts as a competitive inhibitor at the lysine binding sites of plasminogen and inhibits the ability of protease plasmin to cleave the fibrin clot. In large randomized controlled trials, it has been reported to be effective in decreasing perioperative blood loss in a variety of circumstances primarily involving trauma patients. Shakur and co-authors in a trial of 20,000 non-pregnant trauma patients reported a significant reduction in all-cause mortality after TXA administration. In another large study (WOMAN Trial), 20,000 pregnant women with hemorrhage were randomized to TXA or placebo. TXA was associated with a significant decrease in death due to bleeding.
Tranexamic acid's role in treating hemorrhage have been widely studied in non-pregnant populations. Studies of TXA in obstetrics are limited. The American College of Obstetricians and Gynecologists believes the data is insufficient to recommend tranexamic acid for prophylaxis.
The investigators designed a randomized placebo-controlled trial comparing TXA dosing prior to incision for cesarean delivery with a repeat dose given at placental delivery. The purpose is to quantify blood loss during uncomplicated repeat cesarean deliveries with and without TXA. The investigators elected to study scheduled elective cesareans because such procedures are at low risk for profound hemorrhage. It is the intent to have a study cohort where the two treatment groups (TXA or placebo) are as comparable as possible, so the efficacy of TXA is not tested in women with highly variable volumes of obstetric hemorrhage.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Intrauterine pregnancy
- •Gestation age ≥ 37 weeks 0 days
- •Scheduled cesarean delivery
- •Second or third cesarean delivery
- •Singleton pregnancy
排除标准
- •First cesarean delivery
- •Four or more cesarean deliveries
- •Intrauterine fetal death
- •Fetal anomalies
- •Documented coagulopathy (Elevated Prothrombin Time (PT), Elevated Partial Thromboplastin Time (PTT), Elevated International Normalized Ratio (INR))
- •Thrombocytopenia (Platelet count < 100k)
- •Internal bleeding, external bleeding, easy bruising
- •History of thrombotic event
- •Hypertension
- •Diagnosis of renal insufficiency (Creatinine> 1 mg/dL)
- •Insulin-treated diabetes
- •Suspected morbidly adherent placenta
- •Placenta previa
- •Multiple Gestations
- •Hematocrit ≤ 25
- •Blood transfusion within 24 hours prior to cesarean delivery
- •History of abnormal bleeding or blood disorder
- •Planned general anesthesia
研究组 & 干预措施
Tranexamic acid
Tranexamic Acid for intravenous administration.
干预措施: Tranexamic Acid (Drug)
Placebo
Normal saline for intravenous administration.
干预措施: Placebo (Drug)
结局指标
主要结局
Blood Volume Loss
时间窗: 24 hours postpartum.
Total blood volume loss will be calculated in milliliters.
次要结局
- D-Dimer (µg/mL)(Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.)
- Fibrinogen (mg/dL)(Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.)
- Tissue Plasminogen Activator Antigen (ng/mL)(Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.)
- Plasminogen Activator Inhibitor-Type-1 (Units/mL)(Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.)
- Rotational Thromboelastometry INTEM and EXTEM Clotting Time(Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.)
- Rotational Thromboelastometry INTEM, EXTEM, FIBTEM Maximum Clot Firmness(Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.)
研究者
Olutoyosi Ogunkua, MD
Assistant Professor of Anesthesiology
University of Texas Southwestern Medical Center