Blood Loss After Early TXA in Hip Fractures.

Hip Fractures Clinical Trial

Official title:

The Effects of the Timing of Tranexamic Acid Administration on Blood Loss in Hip Fractures.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04488367
• Other study ID #: TXARCT1
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 6, 2020
• Est. completion date: July 2023

Study information

• Verified date: July 2022
• Source: Community Memorial Health System
• Contact: Michael Allen, DO
• Phone: 805-948-5100
• Email: mallen[@]cmhshealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our present study aims to initiate TXA administration immediately upon diagnosis of hip fracture in the Emergency Department. This will be a single blind randomized controlled trial comparing early administration of TXA in the ED in addition to perioperative dosing versus the standard perioperative administration only. The study population will include patients who have sustained a femoral neck, intertrochanteric, or subtrochanteric femur fracture and are undergoing surgical internal fixation or arthroplasty. We will prospectively compare the need for blood transfusion, total and hidden blood loss, postoperative complications, length of stay and readmission within 30 days.

Description:

Consent will be obtained for study enrollment from the patient or legal decision maker. The patient will then be randomized and stratified based on the fracture type, fixation method anticipated, and presence of anticoagulation.

Treatment drug and saline placebo will be blinded from the patient. Treatment arm patients will receive a dose of 10 mg/kg of TXA IV as soon as possible in the ED. They will then receive repeat doses prior to skin incision and again after the end of surgery. Control group will receive a placebo dose of normal saline in the ED and then the standard 10 mg/kg TXA doses prior to surgery and again after the end of surgery. The perioperative doses will not be blinded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Femoral neck, intertrochanteric, subtrochanteric femur fracture

• Age >18

• Undergoing surgical stabilization or arthroplasty by any method as determined by attending surgeon

Exclusion Criteria:

• Age <18

• Concomitant fracture

• Preoperative anemia needing blood transfusion before surgery

• Severe comorbidity (active cancer, severe pulmonary disease, ESRD)

• Allergy for tranexamic acid

• History of acute thromboembolic event (Deep Vein Thrombosis, Pulmonary Embolism, Stroke, TIA) in the previous 12 months

• Myocardial infarction in the previous 12 months

• Renal function impairment (creatinine clearance <30 mL/min), or kidney transplant

• History of hypercoagulability (Factor V Leiden, Protein C/S deficiency)

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Drug:
• Tranexamic acid
10 mg/kg IV TXA in the ED, repeat doses before skin incision and in PACU
• Normal Saline
100 mL 0.9% normal saline in the ED, 10 mg/kg IV TXA before skin incision and in PACU

Locations

Country	Name	City	State
United States	Community Memorial Hospital	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
Community Memorial Health System

Country where clinical trial is conducted

United States, 

References & Publications (7)

Baruah RK, Borah PJ, Haque R. Use of tranexamic acid in dynamic hip screw plate fixation for trochanteric fractures. J Orthop Surg (Hong Kong). 2016 Dec;24(3):379-382. — View Citation

Baskaran D, Rahman S, Salmasi Y, Froghi S, Berber O, George M. Effect of tranexamic acid use on blood loss and thromboembolic risk in hip fracture surgery: systematic review and meta-analysis. Hip Int. 2018 Jan;28(1):3-10. doi: 10.5301/hipint.5000556. — View Citation

CRASH-2 trial collaborators, Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejía-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14. — View Citation

Foss NB, Kristensen MT, Kehlet H. Anaemia impedes functional mobility after hip fracture surgery. Age Ageing. 2008 Mar;37(2):173-8. doi: 10.1093/ageing/afm161. — View Citation

Lei J, Zhang B, Cong Y, Zhuang Y, Wei X, Fu Y, Wei W, Wang P, Wen S, Huang H, Wang H, Han S, Liu S, Zhang K. Tranexamic acid reduces hidden blood loss in the treatment of intertrochanteric fractures with PFNA: a single-center randomized controlled trial. J Orthop Surg Res. 2017 Aug 15;12(1):124. doi: 10.1186/s13018-017-0625-9. — View Citation

Praetorius K, Madsen CM, Abrahamsen B, Jørgensen HL, Lauritzen JB, Laulund AS. Low Levels of Hemoglobin at Admission Are Associated With Increased 30-Day Mortality in Patients With Hip Fracture. Geriatr Orthop Surg Rehabil. 2016 Sep;7(3):115-20. doi: 10.1177/2151458516647989. Epub 2016 May 17. — View Citation

Tian S, Shen Z, Liu Y, Zhang Y, Peng A. The effect of tranexamic acid on hidden bleeding in older intertrochanteric fracture patients treated with PFNA. Injury. 2018 Mar;49(3):680-684. doi: 10.1016/j.injury.2018.01.026. Epub 2018 Feb 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in calculated and recorded hemoglobin	Change in hemoglobin (blood loss) will be assessed based on preoperative blood draw and blood draws post op and on each inpatient day during hospitalization.	From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first.
Primary	Total postoperative units of red blood cell transfusion	The number of units of RBC transfusions will be recorded and compared between treatment and placebo groups.	From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first.
Secondary	VTE	DVT or PE	Postoperative for 30 days
Secondary	Infection	Superficial and deep infections	Postoperative for 30 days
Secondary	Readmission	30 day readmission	Within 30 days postoperative
Secondary	Other complications	Any additional unforeseen complications	Postoperative for 30 days