Clinical trial NCT03742947: Haemostasis and Tranexamic Acid in Caesarean Delivery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Hyperfibrinolysis
Keywords: ancillary biologic study
fibrinolysis
tranexamic acid
post-partum haemorrhage
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Bordeaux Association for Training and Research in Obstetric Gynecology
name: Association of Anesthesiologists and Intensivists of Vascular Surgery and Transplantation
First posted: 2018-11-15
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three blood samples of 20 ml each at T0 after the anesthesia for the caesarean section and before the administration of the product (TXA or placebo), T15 fifteen minutes after the administration of the product and T120, 2 hours after the administration of TRAAP2 study IMP (tranexamic acid or placebo).
Primary purpose: DIAGNOSTIC

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Clot lysis time
timeFrame: Baseline (defined as the time of insertion of the peripheric venous line)
Secondary outcomes:
measure: Lysis Timer clot lysis time
timeFrame: Time 15min and Time 120min (defined as 15 minutes 120 minutes after the administration of the product, respectively)
measure: Routine clot lysis time
timeFrame: Baseline, Time 15min, and Time 120min
measure: t-PA
timeFrame: Baseline, Time 15min, and Time 120min
measure: PAI-1
timeFrame: Baseline, Time 15min, and Time 120min
measure: PAI-2
timeFrame: Baseline, Time 15min, and Time 120min
measure: Euglobulin clot lysis time
timeFrame: Baseline, Time 15min, and Time 120min
measure: Plasminogen
timeFrame: Baseline, Time 15min, and Time 120min
measure: Hb
timeFrame: Baseline, Time 15min, and Time 120min
measure: Platelets
timeFrame: Baseline, Time 15min, and Time 120min
measure: TP
timeFrame: Baseline, Time 15min, and Time 120min
measure: aPTT ratio
timeFrame: Baseline, Time 15min, and Time 120min
measure: Fibrinogen
timeFrame: Baseline, Time 15min, and Time 120min
measure: Fibrin degradation products
timeFrame: Baseline, Time 15min, and Time 120min
measure: Plasmin-antiplasmin complex
timeFrame: Baseline, Time 15min, and Time 120min
measure: Thrombin-antithrombin complex
timeFrame: Baseline, Time 15min, and Time 120min
measure: Bleeding
timeFrame: Baseline, Time 15min, and Time 120min
measure: Transfusion of packs of red blood cells
timeFrame: Time 120min
measure: Transfusion of platelet concentrates
timeFrame: Time 120min
measure: Transfusion of plasma
timeFrame: Time 120min
measure: Transfusion of fibrinogen concentrate
timeFrame: Time 120min
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References: