Use of ROTEM Intraoperatively in Women With Placenta Accreta
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Number of units of blood products transfused
研究概览
简要总结
This study evaluates the use of rapid tests for hematocrit and clotting function in women undergoing surgery for placenta accreta. Half of participants will have these rapid tests performed during surgery to guide blood product transfusion and the other half will have standard lab tests performed to guide transfusion.
详细描述
Placenta accreta has become an increasingly common pregnancy complication. Serious complications are common in patients with placenta accreta, including hemorrhage, transfusion of blood products, abdominal organ injury, bladder surgery, and ICU admission. Hemorrhage, or excessive blood loss, is the most common complication and often results in impaired ability for the body to form blood clots normally.
The development of rapid testing of hematocrit and clotting function may allow for earlier identification of patients who have severe blood loss and development of clotting abnormalities. The investigators are testing whether use of this technology in patients undergoing surgery for placenta accreta, with earlier identification of patients with severe blood loss or clotting abnormality, will result in a lower need for transfusion and fewer complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with placenta accreta during pregnancy who are scheduled to have delivery by cesarean section with hysterectomy to follow.
排除标准
- •Non-English speaking
研究组 & 干预措施
ROTEM
Participants randomized to this arm will have rapid testing of hematocrit and clotting function every 30 minutes during the hysterectomy portion of their surgery for placenta accreta, with transfusion of blood products based on defined abnormalities in these tests.
干预措施: ROTEM (Procedure)
Standard treatment
Participants randomized to this arm will have standard visual assessment of blood loss and standard laboratory studies to assess blood count and clotting function when indicated during the hysterectomy portion of their surgery for placenta accreta. Transfusion of blood products will be based on abnormalities of these test results.
干预措施: standard treatment (Procedure)
结局指标
主要结局
Number of units of blood products transfused
时间窗: From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier
次要结局
- Number of hours spent in ICU(From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier)
- Presence of infection at the surgery site(From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier)
- Number of days in the hospital(From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier)
- Readmission for other complications(For up to 6 weeks after surgery)
研究者
Brett Einerson
Principal Investigator
University of Utah