Hip Fractures Clinical Trial
Official title:
The Effect of Preoperative Tranexamic Acid on Blood Loss and Transfusion Rates in Intertrochanteric and Subtrochanteric Femur Fractures.
The objective of this study is to evaluate the effect of Tranexamic Acid (TXA) on blood loss and need for perioperative blood transfusion following intertrochanteric and subtrochanteric femur fractures. TXA is a antifibrinolytic medication that prevents the breakdown of blood clots by inhibiting the activation of plasminogen to plasmin in the coagulation cascade. Our hypothesis is that by providing TXA at the time of hospital admission it will decrease the amount of preoperative and intraoperative bleeding thereby leading to a decreased need for post-operative transfusion. This a double blinded, placebo controlled, therapeutic trial in which half of patients will be randomized to receive TXA at the time of hospital admission and half of patients will receive a placebo.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | March 2017 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients sustaining a closed intertrochanteric femur fracture presenting to the Good Samaritan Regional Medical Center. - Patients who are willing and able to consent to participate in the study - >18 years of age Exclusion Criteria: - Patients with an allergy to tranexamic acid. - History of thromboembolic event (pulmonary embolism, cerebral vascular accident, deep venous thrombosis), - History of renal impairment (Cr > 1.5 or glomerular filtration rate < 30) - Coronary stents - History of hypercoagulability (Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant). - Color blindness - Subarachnoid hemorrhage |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Good Samaritan Hospital Corvallis | Corvallis | Oregon |
Lead Sponsor | Collaborator |
---|---|
Good Samaritan Regional Medical Center, Oregon |
United States,
Desai SJ, Wood KS, Marsh J, Bryant D, Abdo H, Lawendy AR, Sanders DW. Factors affecting transfusion requirement after hip fracture: can we reduce the need for blood? Can J Surg. 2014 Oct;57(5):342-8. — View Citation
Kadar A, Chechik O, Steinberg E, Reider E, Sternheim A. Predicting the need for blood transfusion in patients with hip fractures. Int Orthop. 2013 Apr;37(4):693-700. doi: 10.1007/s00264-013-1795-7. Epub 2013 Feb 5. — View Citation
Vijay BS, Bedi V, Mitra S, Das B. Role of tranexamic acid in reducing postoperative blood loss and transfusion requirement in patients undergoing hip and femoral surgeries. Saudi J Anaesth. 2013 Jan;7(1):29-32. doi: 10.4103/1658-354X.109803. — View Citation
Zufferey PJ, Miquet M, Quenet S, Martin P, Adam P, Albaladejo P, Mismetti P, Molliex S; tranexamic acid in hip-fracture surgery (THIF) study. Tranexamic acid in hip fracture surgery: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):23-30. doi: — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Calculated Blood Loss | Admission to discharge, 3-4 days on average. | Yes | |
Other | Length of Stay | Admission to discharge, 3-4 days on average. | No | |
Other | Myocardial Infarction | Admission to discharge, 3-4 days on average. | Yes | |
Other | Deep Venous Thrombosis | Admission to discharge, 3-4 days on average. | Yes | |
Other | Pulmonary Embolism | Admission to discharge, 3-4 days on average. | Yes | |
Other | Cerebrovascular Accident | Admission to discharge, 3-4 days on average. | Yes | |
Other | Surgical Site Infection Rate | Admission to discharge, 3-4 days on average. | Yes | |
Primary | Perioperative Blood Loss | Perioperative blood loss measured by serial hemoglobin and hematocrit | Admission to discharge, 3-4 days on average. | Yes |
Primary | Blood Transfusion Rates | Admission to discharge, 3-4 days on average. | Yes |
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