Haemorrhagic ceaserean MedDRA version: 18.1 Level: LLT Classification code 10036418 Term: Postpartum hemorrhage System Organ Class: 100000004868
Conditions
Sponsors
Centre Hospitalier Régional et Universitaire de Lille
Eligibility
Inclusion criteria
Inclusion criteria: - Each patient experiencing a bleeding volume of more than 800 mL during an elective or emergent caesarean section - Patient covered by social security Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patient unable to consent and/or 2) • Administration of TA before inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to assess the efficacy of two (standard and low) doses regimens intravenous bolus of tranexamic acid (1g and 0,5g), compared to placebo, to reduce the measured blood loss when administered at the onset of an active PPH during elective or emergent caesarean section.;Secondary Objective: The secondary objectives are: to assess the impact of the two dose regimens of 1g and 0,5g TA on • the maternal morbidity observed by anemia, surgical interventional procedures rates, length of the cesarean section, general anesthesia rate, immediate and late transfusion rate, prohaemostatic products need, organ failures, intensive care admission rate and ICU duration, length of breast feeding and hospital stay until discharge and death, • The incidence of the potential side effects of tranexamic acid: seizures, visual disturbance and vomiting or thrombosis and renal failure. • the inhibition of the biological fibrinolysis • the pharmacological distribution of the product TA in the maternal blood, in uterus bleeding and urines. • The inhibition of the biological fibrinolysis as measured by D Dimers and PAP maximal peak ;Primary end point(s): Blood loss volume measured between inclusion and 6 hours after. ;Timepoint(s) of evaluation of this end point: Blood loss voume at time 6hours after inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The rate of surgical interventional procedures such as arterial ligature, or surgical compression of the uterine wall or internal compression balloon. • The intensity and rate postoperative anaemia: decrease of haemoglobin preoperative to day +2, nadir of haemoglobin, number of patients with haemoglobin 4g/dL at any time .compared with the third trimester haemoglobin. • The immediate and late red blood cell transfusion and prohemostatic products infusion. • The CS length. • The rate of postoperative organ failures and length of intensive care hospitalization. • The length of breast feeding. • Death. • Side effects: nausea, vomiting, seizures, visual disturbances, renal failure, thrombosis. • D Dimers and haemostasis parameters specifically focused on the diagnosis and evolution of fibrinolysis. ;Timepoint(s) of evaluation of this end point: 6 hours after inclusion | — |
Countries
France
Contacts
Public ContactAramatoulaye SAMBOU
Hospitalier Régional et Universitaire de Lille
Outcome results
None listed