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临床试验/NCT01416454
NCT01416454已完成不适用

Thromboelastography to Assess Age-Related Coagulation Differences in Patients Undergoing Elective Cesarean Delivery.

Stanford University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Thromboelastography parameters

研究概览

简要总结

The purpose of the study is to assess potential age-related differences on coagulation profile of patients undergoing Cesarean Section, using thromboelastography (TEG). The investigators will compare coagulation data collected from the study to assess potential differences in coagulation parameters for the following age groups: (i) women less than 35 yrs (ii) women 35 yrs or older.

详细描述

The purpose of the study is to assess potential age-related differences on coagulation profile of patients undergoing Cesarean Section, using thromboelastography (TEG). The investigators will compare coagulation data collected from the study to assess potential differences in coagulation parameters for the following age groups: (i) women less than 35 yrs (ii) women 35 yrs or older. This study will allow us to collect more information about differences regarding coagulation profile in patients undergoing cesarean section who are less than 35 y vs. 35y or older. This information will add to current knowledge base about potential risk for thrombotic events according with age.

All obstetric patients presenting for elective Cesarean delivery (CD) will be informed about the study prior to and on admission to the labor and delivery unit. Patients will be informed at parents' education classes (during education sessions by obstetric anesthesiologists who are also members of the research team). Potential participants will be approached by a member of the research team prior to surgery. A study investigator will obtain patient written informed consent.

Pre-operatively, blood sampling will take place by venepuncture for the following analysis:

Hematocrit, Platelet count (which are part of standard of care), TEG, prothrombin time (PT), Partial Thromboplastin Time (PTT), International Normalized Ratio (INR), fibrinogen (for research purposes only, unless they are needed for clinical purposes).

The investigators would prefer to avoid taking blood samples from indwelling peripheral IV lines, as the samples will likely be diluted with intravenous fluid and therefore may significantly affect blood sampling analysis. The volumes of blood necessary for TEG analysis are extremely small (1 ml - less than half of a teaspoon - per TEG analysis; total =3 samples), and therefore will not significantly affect any potential degree of hemorrhage or total blood loss incurred. The volumes of blood for laboratory analysis will also be small (4-5 ml - about 1 teaspoon - for each research sample: total =3 samples), and will not affect overall blood loss. No randomization will be possible. TEG and laboratory samples will be taken at the following time intervals: prior to anesthesia in the preoperative holding unit, post-operative days one and three.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • All obstetric patients with singleton pregnancies admitted to the labor and delivery unit at LPCH who undergo elective Cesarean delivery with neuraxial anesthesia.
  • We will enroll only healthy patients with singleton pregnancies and whose pregnancy is not result of in vitro fertilization.

排除标准

  • Patients with underlying coagulation disorders.
  • Patients with thrombocytopenia.
  • Patients with pregnancy-induced hypertension, pre-eclampsia.
  • Patients requiring the following medications prior to surgery: non-steroidal anti-inflammatories, aspirin, anticoagulants.
  • Patients requiring non-elective Cesarean delivery.
  • Patients with significant obstetric or medical disease.
  • No patients <18 years of age will be recruited.

结局指标

主要结局

Thromboelastography parameters

时间窗: 3 days

Thromboelastography parameters include: Reaction (r) time Clot Formation (k) time Alpha Angle Maximum Amplitude (MA) Time to maximum rate of thrombus generation (Tmax) Maximum rate of thrombus generation (MRTG) Total Thrombus generated (TTG)

次要结局

  • laboratory coagulation parameters(3 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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