Study of Peripartum Haemostasis and Effects of Tranexamic Acid in Caesarean Delivery: Biologic Ancillary Study in TRAAP2 Patients Recruited at the Bordeaux University Hospital: BIO-TRAAP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Clot lysis time
研究概览
简要总结
The aim of the study is to evaluate haemostasis and fibrinolysis in peripartum of caesarean delivery and the effect of tranexamic acid (TXA) given in prevention of post-partum haemorrhage (PPH).
详细描述
Post-partum haemorrhage (PPH) remains a leading cause of maternal morbidity and mortality. Haemostasis and fibrinolysis are activated in peripartum. Fibrinolysis is decreased during pregnancy, is quickly activated after childbirth and can be overactivated in case of PPH. Tranexamic acid (TXA), an antifibrinolytic drug, has been proven to efficiently decrease bleeding and death in PPH. Its place in prevention of PPH after caesarean section remains to be established. The aim of the study protocol TRAAP2 is to conduct a large multicentre randomized, double blind placebo-controlled trial to adequately assess the impact of TXA for preventing PPH following a caesarean section. Peripartum is also a period of increased thrombo-embolic risk. TXA has never been proven to increase thromboembolic events. Nevertheless, it seems important to reserve TXA for women with activated fibrinolysis.
The aim of the ancillary biologic study BIO-TRAAP is thus to explore haemostasis and fibrinolysis in peripartum, to determine which women will in the future benefit from TXA. Fibrinolysis will be studied by clot lysis time by Global Fibrinolytic Capacity test on the Lysis Timer (GFC/LT), t-PA, PAI-1, PAI-2, euglobulin clot lysis time, plasminogen, plasmin-anti-plasmin complex, thrombin-anti-thrombin complex, fibrin degradation products (FDP).
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
- Double (Participant, Investigator)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patient randomized into TRAAP2 study (NCT03431805):
- •adult women admitted for a planned caesarean delivery,
- •at term ≥ 34 weeks,
- •haemoglobin level at the last blood sample >9g/dl,
- •blood Formula numbering within 7 days before caesarean delivery, informed signed consent)
- •informed signed consent for BIO-TRAAP
排除标准
- •patient not included into TRAAP2 study:
- •previous thrombotic event or pre-existing pro-thrombotic disease,
- •epileptic state or history of seizures,
- •presence of any chronic or active cardiovascular disease outside hypertension,
- •any chronic or active renal disease including renal, chronic or acute insufficiency (glomerular flow <90mL / min), and chronic or active liver disease at risk thrombotic or haemorrhagic,
- •autoimmune disease,
- •sickle cell disease,
- •placenta praevia,
- •placenta accreta/increta/percreta,
- •abruption placentae,
- •eclampsia,
- •HELLP syndrome,
- •in utero fetal death,
- •administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery,
- •general anaesthesia,
- •hypersensitivity to tranexamic acid or concentrated hydrochloric acid, instrumental extraction failure,
- •multiple pregnancy with genital delivery of the first twin and caesarean delivery for the second or at third trimester,
- •poor understanding of the French language
研究组 & 干预措施
Tranexamic acid
intravenous administration of 10-mL of tranexamic acid (EXACYL® 1 g/10 ml I.V., solution injectable)
干预措施: peripartum haemostasis (Diagnostic Test)
Chloride solution
sodium intravenous administration of 10-mL of chloride solution (0.9% -10mL)
干预措施: peripartum haemostasis (Diagnostic Test)
结局指标
主要结局
Clot lysis time
时间窗: Baseline (defined as the time of insertion of the peripheric venous line)
Clot lysis time in minutes studied by the Global Fibrinolytic Capacity on the Lysis Timer
次要结局
- t-PA(Baseline, Time 15min, and Time 120min)
- Euglobulin clot lysis time(Baseline, Time 15min, and Time 120min)
- Fibrinogen(Baseline, Time 15min, and Time 120min)
- Bleeding(Baseline, Time 15min, and Time 120min)
- PAI-1(Baseline, Time 15min, and Time 120min)
- Plasminogen(Baseline, Time 15min, and Time 120min)
- TP(Baseline, Time 15min, and Time 120min)
- Fibrin degradation products(Baseline, Time 15min, and Time 120min)
- Transfusion of platelet concentrates(Time 120min)
- Routine clot lysis time(Baseline, Time 15min, and Time 120min)
- aPTT ratio(Baseline, Time 15min, and Time 120min)
- Transfusion of packs of red blood cells(Time 120min)
- PAI-2(Baseline, Time 15min, and Time 120min)
- Hb(Baseline, Time 15min, and Time 120min)
- Platelets(Baseline, Time 15min, and Time 120min)
- Plasmin-antiplasmin complex(Baseline, Time 15min, and Time 120min)
- Thrombin-antithrombin complex(Baseline, Time 15min, and Time 120min)
- Transfusion of plasma(Time 120min)
- Lysis Timer clot lysis time(Time 15min and Time 120min (defined as 15 minutes 120 minutes after the administration of the product, respectively))
- Transfusion of fibrinogen concentrate(Time 120min)