Effect of Intravenous Tranexamic Acid on Reduction of Blood Losses in Hip Fracture Patients

• Status: Recruiting
• Trial end date: 2022-04-08
• Target enrollment: 0
• Participant gender: All

Summary

Studies have shown that hip fractures have a significant perioperative blood loss. Postoperative anaemia is associated with a higher morbidity and mortality.

Tranexamic acid is a safe and effective antifibrinolytic widely used to reduce blood loss in other forms of orthopaedic surgery and in traumatized patients. However, evidence on the effectiveness of TXA in lower extremity fracture care is more limited.

Hip fractures represent a common orthopedic injury in a fragile patient population that often necessitates post-operative blood transfusion thereby putting the patient at additional risk of complications.

The goal of this study is to assess if the use of tranexamic acid in patients with hip fractures will result in a reduction in blood losses and blood transfusion rates.

Our hypothesis is that by providing intravenous TXA at the time of surgery will decrease the amount of preoperative and intraoperative bleeding thereby leading to a decreased need for postoperative transfusion.

This a double blinded, placebo controlled, therapeutic trial in which the patients will be randomized to receive TXA or a placebo (saline solution). Treatment will be administered pre-operatively as well as at the time of surgical incision. The primary outcome will be need for blood transfusion. Secondary outcomes will include calculated perioperative blood loss, length of stay, and rate of thromboembolic events, and 90 day mortality.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alejandro Lizaur-Utrilla, PhD, MD
• Collaborator: University of Alicante
• Treatments: Pharmaceutical Solutions; Tranexamic Acid

Criteria

Inclusion Criteria:

• consecutive patients with a diagnosis of hip fractures treated at our hospital by any surgical procedureExclusion Criteria:

• Age over 60 years

Exclusion Criteria:

• ASA IV

• Concomitant fracture

• Refusal to receive blood products

• Preoperative anemia needing blood transfusion before surgery

• Severe comorbidity (cancer, severe pulmonary disease)

• Allergy for tranexamic acid.

• History of acute thromboembolic event (Deep Vein Thrombosis, Pulmonary Embolism, Stroke)

• Coagulopathy (INR > 1.4)

• Myocardial infarction in the previous 12 months

• Coronary stents

• Renal function impairment (serum creatinine > 2 mg/dL or creatinine clearance <30 mL/min),) or kidney transplant

• Platelet antiaggregant treatment in the week before surgery.

• Severe hepatic dysfunction (AST/ALT >60)

• History of hypercoagulability

• Acquired disturbances of color vision.

• Occurrence intraoperative surgical/medical/anesthetic complications