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:

* Age: 18 - 85 years
* Sex: Both male and female will be included. The male-to-female ratio will depend upon the patient population.
* Stable Health: At the time of surgery based on physical examination and medical history.
* Patient exhibited preoperative radiographic evidence of joint degeneration consistent with TKA that could not have been treated in non-operative fashion.
* Patient had severe knee pain and disability due to degenerative joint disease.
* Patient or patient's legal representative has signed the Informed Consent form. The patient is capable of making informed decisions regarding his/her healthcare.

Exclusion Criteria:

* Patients with history of liver disease. Patients with liver dysfunction from cirrhosis or hepatitis may have impaired production of factors in the clotting cascade which may make these individuals more prone to bleed, especially with the use of anticoagulants. For this reason, these patients will also be excluded from this study if a baseline INR if greater than 1.3.
* Patients allergic to materials of bovine origin.
* Patients predonating autologous blood.
* Patients with a preoperative platelet count of less than 100,000.
* Patients undergoing bilateral or revision surgery.
* Evidence of bleeding or metabolic - based hemolytic disorder (hemophilia or anticoagulation use), or hypercoaguable disorder.
* Previous history of infection in the affected joint.
* Peripheral vascular disease.
* Patient was a poor compliance risk - treated for ethanol or drug abuse, physical or mental handicap, etc.
* Patients with a previous history of venous thromboembolism, or other reason for requiring anticoagulation other than ASA 325 mg po BID and mechanical compression.
B: Inclusion Criteria:

* Patients who are to undergo elective hip or knee joint replacement
* Must be cemented arthroplasty
* Must be primary arthroplasty

Exclusion Criteria:

* Uncemented arthroplasty.
* Revision arthroplasty.
* Patients on anticoagulant (warfarin, low molecular weight heparin) or other medication known to affect clotting (except aspirin, which is to be given as part of standard DVT prophylaxis in all cases).
* Other drugs that may affect the activity of the drugs under investigation.
* Allergy to asprin (all patients to receive 150mg aspirin as standard DVT prophylaxis for 6 weeks).
* Patients with known coagulopathy (APTT or PT outside normal range pre-operatively).
* Previous reaction or ethical/religious objection to receiving blood products (Quixil contains a derivative of human blood).
* Pregnancy or breastfeeding.
* Patients who have a past medical history of thrombo-embolism at any time.
* Patients who need intravenous fluid administration for greater than 24 hours following operation.
* Patients who need allogenic blood transfusion within study period.
* Jehovah's Witnesses, or any other group of patients with ethical objections to receiving blood products.
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:

* patient scheduled for TKR
* written informed consent
* diagnosis of osteoarthritis

Exclusion Criteria:

* previous intervention on the same Knee (except for meniscectomy)
* Hb pre-operative level lower than 12g/dl for man and 11g/dl for woman
* Anticoagulation therapy or any anti-aggregate treatment not suspended at least 4 days before surgery

Answer: C