Please select the eligibility criteria that correspond to the clinical trial below.
Title: TOPICAL AND INTRAVENOUS ADMINISTRATION OF TRANEXAMIC ACID ARE EQUALLY EFFECTIVE IN DIRECT ANTERIOR TOTAL HIP ARTHROPLASTY - A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL
Brief Summary: Through a randomized controlled trial, we will compare the intravenous administration of tranexamic acid with the intra-articular application after a total hip arthroplasty through direct anterior approach.

* RCT, prospective study
* Academic-monocentric study
* Clinical outcome measurements The postoperative blood loss will be the primary outcome. Secondary outcomes are

  1. The rate of perioperative and postoperative blood transfusion
  2. The number of blood units transfused
  3. The length of hospital stay
  4. Perioperative given intravenous isotonic fluid

The Null-hypothesis is that there is no significant difference in postoperative blood loss between intra-articular and intravenous administration of TXA.


Options:
A: Inclusion Criteria:

* Age ≥ 18 years,
* Osteoporotic Fractures of the upper end of the femur requiring surgical repair.
* Preoperative hemoglobin between 9.5 and 13 g/dl.
* Patient or relative signed informed consent or inclusion thanks to urgent inclusion procedure

Exclusion Criteria:

* Bone marrow disease or ongoing treatment (such as chemotherapy), which could interfere with bone marrow erythropoiesis,
* Known allergy or counter-indication to iron and/or to tranexamic acid,
* Uncontrolled arterial hypertension,
* Recent iron infusion (within one week),
* Blood transfusion within one week before inclusion or preoperative blood transfusion already scheduled,
* Any patient who cannot be transfused or has refused consent for a blood transfusion,
* Bedridden or very dependent patient (equivalent to GIR 1 or 2 class).
* Non-affiliation to French health care coverage,
* Adult patient protected under the law (guardianship),
* Pregnancy.
B: Inclusion Criteria:

* All adults (patients over the age of eighteen years) who were scheduled for a primary unilateral total hip arthroplasty due to osteoarthritis at Ziekenhuis Oost-Limburg, Genk, Belgium are eligible for inclusion in the study.

Exclusion Criteria:

* History of coagulopathy
* Allergy to tranexamic acid
* preoperative anemia
* fibrinolytic disorders
* history of arterial or venous thromboembolic disease
* disturbances of color vision
* pregnancy
* breastfeeding
* major comorbidities
* participation in another clinical trial
C: Inclusion Criteria:

All of the following criteria must be met to be eligible:

1. 18 years of age or older
2. Diagnosis of hip fracture (Intracapsular, Intratrochanteric or Subtrochanteric) requiring surgical repair
3. Patient/surrogate decision maker provide signed informed consent

Exclusion Criteria:

Participants cannot be included in this study if any of the following criteria apply:

1. Patient has documented renal failure with glomerular filtration rate of \<30ml/min/1.73m2
2. Documented allergy to tranexamic acid
3. Current use of hormone replacement therapy
4. Acquired disturbances of colour vision
5. Refusal of blood products
6. Pre-operative use of anticoagulant therapy (Coumadin, heparin \< 5 days of surgery, fibrinolytic disorders requiring intraoperative anti-fibrinolytic treatment)
7. Coagulopathy (pre-operative platelet count \<150,000/mm3, International Normalized Ratio (INR) \>1.4, prolonged Partial Thromboplastin Time (PTT) \>1.4x normal)
8. Hematuria
9. Acute coronary syndrome within 6 weeks of fracture
10. Any history of venous thromboembolism
11. Any intraoperative surgical/medical/anesthetic complications i.e.: myocardial infarction or neurovascular injury occurring prior to application of the tranexamic acid
12. Pregnant or lactating
13. Any major medical or psychiatric disorder that in the opinion of the investigator, might prevent the subject from completely participating in the study or interfere with the interpretation of the study results
14. Unable/unwilling to provide informed consent
D: Inclusion Criteria:

* Patient requiring surgery for an isolated hip fracture of less than 48 hours

Exclusion Criteria:

* Contraindication to tranexamic acid
* Contraindication to fondaparinux
* Contraindication to general anesthesia associated with a femoral nerve block
* pregnancy

Answer: B