Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Large Randomised Placebo Controlled Trial Among Trauma Patients With, or at Risk of, Significant Haemorrhage, of the Effects of Antifibrinolytic Treatment on Death and Transfusion Requirement
Brief Summary: CRASH 2 is a large pragmatic randomised placebo controlled trial of the effects of the early administration of the antifibrinolytic agent tranexamic acid on death, vascular events and transfusion requirements. Adults with trauma who are within 8 hours of injury and have either significant haemorrhage, or who are considered to be at risk of significant haemorrhage, are eligible if the responsible doctor is for any reason substantially uncertain whether or not to use an antifibrinolytic agent. Numbered drug or placebo packs will be available in each participating emergency department. Randomisation will involve calling a 24-hour freecall randomisation service. The call should last only a minute or two and at the end of it the randomisation service will specify which numbered treatment pack to use. For hospitals where telephone randomisation is not feasible, randomisation will be by taking the next consecutively numbered treatment pack. No extra tests are required but a short form must be completed one month later or on discharge or on death (whichever occurs first).


Options:
A: Inclusion Criteria:

Experimental group: Each patient

* experiencing a bleeding volume of more than 800 mL
* due to surgery or to atony uterine
* during an elective or non-emergent caesarean section
* secondary post-partum haemorrhage after caesarean section, even if CS has been emergent
* after complete information and consent signature.
* covered by social security. Reference non-hemorrhagic group: Each patient
* experiencing a bleeding volume of strictly less than 800 mL
* during an elective or emergent caesarean section
* after complete information and consent signature.
* covered by social security.

Exclusion Criteria:

Patient unable to consent (\<18 years old or incapable people and specially protected mentioned in the article L1121-5 to L1121-8) RCP medical contraindication to tranexamic acid such as

* Hypersensibility to the product or excipient,
* Previous or ongoing arterial or venous thrombosis,
* Coagulopathy, except DIC associated with a predominant fibrinolytic profile,
* Renal failure,
* Previous seizures,
* intrathecal or intraventricular administration. Obstetrical contraindication to TA
* Severe HELLP syndrome (platelet count \<50 000/m3 or renal failure prior to the caesarean (RIFLE score\>2) Protocol related contraindication to inclusion
* Administration of TA before inclusion-Inherited haemorrhagic diseases and low molecular weight heparin within 24 hours before inclusion
* Patients who participated in a study on the efficacy of an experimental drug in the two month preceding the caesarean section
* Inherited haemorrhagic diseases or low molecular weight heparin within 24 hours before inclusion
* Previous inclusion in an interventional trial since the 2 months before CS
B: Inclusion Criteria:

* • Grand multipara

  * Multiple pregnancy
  * Polyhydraminos (AFI is more than 24 cm).
  * Placenta previa
  * Gestational diabetes mellitus
  * Preeclampsia
  * Anemia complicating pregnancy (Hemoglobin is less than 11 gm/dl)

Exclusion Criteria:

* • Allergy to tranxemic acid.

  * H/o suggestive of bleeding disorders
  * previous history of deep vein thrombosis
  * Abnormally invasive placenta
  * Emergency cesarean sections
  * Intraoprative complications during cesarean sections as uterine artery injury and broad ligamentary hematoma.
C: Inclusion Criteria:

All trauma patients with ongoing significant haemorrhage (systolic blood pressure less than 90 mmHg and/or heart rate more than 110 beats per minute), or who are considered to be at risk of significant haemorrhage, and are within 8 hours of the injury, are eligible for trial entry if they appear to be at least 16 years old. Although entry is allowed up to 8 hours from injury, the earlier that patients can be treated the better.

Exclusion Criteria:

The fundamental eligibility criterion is the responsible doctor's 'uncertainty' as to whether or not to use an antifibrinolytic agent in a particular adult with traumatic haemorrhage. Patients for whom the responsible doctor considers there is a clear indication for antifibrinolytic therapy should not be randomised. Likewise, patients for whom there is considered to be a clear contraindication to antifibrinolytic therapy (such as, perhaps, those who have clinical evidence of a thrombotic disseminated intravascular coagulation) should not be randomised. Where the responsible doctor is substantially uncertain as to whether or not to use an antifibrinolytic, all these patients are eligible for randomisation and should be considered for the trial. There are no other pre-specified exclusion criteria
D: Inclusion criteria:

1. Undergoing noncardiac surgery;
2. ≥ 45 years of age;
3. Expected to require at least an overnight hospital admission after surgery;
4. Provide written informed consent to participate in the POISE-3 Trial, AND
5. Fulfill ≥1 of the following 6 criteria (A-F):

A. NT-proBNP ≥200 ng/L B. History of coronary artery disease C. History of peripheral arterial disease D. History of stroke E. Undergoing major vascular surgery; OR F. Any 3 of 9 risk criteria i. Undergoing major surgery; ii. History of congestive heart failure; iii. History of a transient ischemic attack; iv. Diabetes and currently taking an oral hypoglycemic agent or insulin; v. Age \>70 years; vi. History of hypertension; vii. Serum creatinine \> 175 µmol/L (\> 2.0 mg/dl); viii. History of smoking within 2 years of surgery; ix. Undergoing emergent/urgent surgery.

Exclusion criteria:

1. Patients undergoing cardiac surgery
2. Patients undergoing cranial neurosurgery
3. Planned use of systemic TXA during surgery
4. Low-risk surgical procedure (based on individual physician's judgment)
5. Hypersensitivity or known allergy to TXA
6. Creatinine clearance \<30 mL/min (Cockcroft-Gault equation) or on chronic dialysis
7. History of seizure disorder
8. Patients with recent stroke, myocardial infarction, acute arterial thrombosis or venous thromboembolism (\<3 month)
9. Patients with fibrinolytic conditions following consumption coagulopathy
10. Patients with subarachnoid hemorrhage within the past 30 days
11. Women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding
12. Previously enrolled in POISE-3 Trial

Answer: C