Please select the eligibility criteria that correspond to the clinical trial below.
Title: Tranexamic Acid for the Treatment of Gastrointestinal Haemorrhage: an International Randomised, Double Blind Placebo Controlled Trial
Brief Summary: Severe bleeding in the digestive system is a common symptom of many diseases. Each year, about 50,000 people end up in British hospitals because of this problem and about 5,000 of them die. The most common cause of this bleeding is stomach ulcers. In sub-Saharan Africa, schistosomiasis (parasitic worms) is responsible for about 130,000 deaths from stomach bleeding each year. From previous research in other bleeding conditions such as surgery and trauma, we know that a drug called tranexamic acid can reduce bleeding and save lives. We now want to do the HALT-IT trial to see if giving tranexamic acid can save lives and if there are any complications in people with severe bleeding from the digestive system.


Options:
A: Inclusion Criteria:

* Willing and able to provide written informed consent
* Age \>17 and \< 86 years
* Patients undergoing planned cardiopulmonary bypass (CPB) for:

  1. combined coronary artery bypass grafting and valve replacement/repair surgery
  2. single valve replacement surgery
  3. mitral valve repair surgery

  3. or double valve surgery (aortic and mitral)
* Presence of clinically relevant microvascular bleeding after protamine administration (hemostasis assessment score of 2-3)
* Patients should fulfill the following parameters prior to the study intervention:

  * Body temperature \> 35.0°C
  * Blood pH \> 7.2
  * Hb \> 7.0 mg/dL
  * Activated clotting time (ACT) \< 155 seconds
  * CPB time \> 60 minutes

Exclusion Criteria:

* Replacement of aorta
* Planned valve replacement without median sternotomy
* Previous valve replacement surgery (previous coronary artery bypass graft (CABG) acceptable)
* History or suspicion of a congenital or acquired coagulation disorder such as hemophilia, von Willebrand disease, and liver disease
* Hemodialysis dependent renal failure
* Liver dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) increased ≥ 2-fold above the upper limit of local laboratory normal ranges)
* Known allergy/anaphylaxis to fibrinogen concentrate or apheresis platelet units
* Clopidogrel administration within 5 days of surgery
* Coumadin (warfarin) administration within 5 days of surgery
* Participation in another clinical study in the 4 weeks preceding surgery
* Any indication that a potential subject did not comprehend the study restrictions, procedures, or consequences therein an informed consent cannot be convincingly given
* Life expectancy less than 48 hours
B: Inclusion Criteria:

1. Informed consent from participant.
2. Women who develop PPH defined as bleeding from uterus and/or the birth canal within 24 hours postpartum.
3. Age ≥ 18 years.
4. If vaginal birth: indication of one of the following procedures at the operation theatre with anaesthetic assistance: a) Estimated blood loss ≥ 500 ml and indication of manual removal of placenta or b) Indication of manual exploration of the uterus due to continuous bleeding after the birth of placenta.
5. If birth by Caesarean section: A perioperative blood loss ≥ 1000 ml.

Exclusion Criteria:

1. Patients with known inherited deficiencies of coagulation.
2. Patients in anti-thrombotic treatment prepartum due to increased risk of thrombosis.
3. Patients with a pre-pregnancy weight \<45 kg.
4. Patients who refuse to receive blood transfusion.
C: Inclusion Criteria:

* adult patients
* with acute significant upper or lower gastrointestinal bleeding
* where the responsible clinician is substantially uncertain as to the appropriateness of antifibrinolytic agents in the patient

Exclusion Criteria:

* The fundamental eligibility criterion is the responsible clinician's 'uncertainty' as to whether or not to use an antifibrinolytic agent in a particular patient with upper or lower gastrointestinal bleeding.
* There are no other exclusions.
D: Inclusion Criteria:

At Screening:

* Undergoing elective open surgical procedures on any part of the aorta requiring cardiopulmonary bypass (CPB), with or without other cardiac surgical procedures (e.g. valve replacement or repair, coronary artery bypass grafting, etc.).
* 18 years of age or older.
* Written informed consent for study participation obtained before undergoing any study specific procedures.

Intraoperative (at the 1st 5-minute bleeding mass):

* A 5-minute bleeding mass of 60 to 250 g following discontinuation of CPB, administration of protamine, and establishment of surgical hemostasis.
* Minimum core body temperature 35°C, measured according to local practice.
* Activated clotting time ± 25% of baseline levels.
* Blood pH \> 7.3.

Exclusion Criteria:

At Screening and/or baseline:

* Undergoing emergency aortic repair surgery.
* Reoperative aortic surgery at the same anatomic site as the original procedure such as replacement of a previously placed aortic graft. Resternotomy and rethoracotomy are permitted.
* Any operation for infection.
* Proof or suspicion of a congenital or acquired coagulation disorder (e.g. Von Willebrand's disease, hemophilia or severe liver disease) or a prothrombotic disorder (e.g. protein C or S deficiency).
* Myocardial infarction (MI), acute coronary syndrome or stroke in the 2 months preceding study surgery.
* Low molecular weight or unfractionated heparin in the 24 hours preceding study surgery.
* Clopidogrel administration within 5 days preceding study surgery or prasugrel administration within 7 days preceding study surgery or ticagrelor administration in the 48 hours preceding study surgery.
* Factor Xa inhibitors within 2 days preceding study surgery.
* IIb/IIIa antagonist administration in the 24 hours preceding study surgery.
* Use of direct thrombin inhibitors: within 3 days preceding study surgery for dabigatran and within 24 hours preceding study surgery for all others.
* An international normalized ratio \> 1.3 immediately preceding the start of surgery.

Intraoperative (at the 1st 5-minute bleeding mass):

* Use of any systemic hemostatic therapy (such as FFP, platelets, prothrombin complex concentrates) from the beginning of surgery until IMP administration.

Answer: C