Clinical trial NCT04290884: Tranexamic Acid in Chinese Elderly Patients With Intertrochanteric Fracture RCT
Official title: The Use of Tranexamic Acid in Chinese Elderly Patients Undergoing Femoral Nailing for Intertrochanteric Fracture: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fracture of Femur
Keywords: elderly
intertrochanteric fracture
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hip fracture posed a major challenge to the health care system, with the one-year mortality of hip fracture reported as being approximately 20%. Perioperative haemoglobin level was associated with functional level of the patient and even mortality.

Different methods for administration of tranexamic acid had been described. It was well established that systemic administration of tranexamic acid could reduce perioperative blood loss and transfusion rate. Topical administration had been shown to decrease blood loss and transfusion rate.

The objective of our study is to investigate the hypothesis that tranexamic acid will reduce blood loss and transfusion rate in elderly patients undergoing hip fracture surgery.

Detailed description: The incidence of geriatric hip fractures is projected to increase by more than 250% in the next twenty-five years as the world population ages. Hip fracture in elderly patients are associated with significant morbidity and mortality. One of the significant morbidity is blood loss, which has been reported as high as 1500ml. Blood loss may lead subsequent blood transfusion. The rate of blood transfusion has been reported between 20 to 60%. Blood loss and subsequent blood transfusion could lengthen the overall hospital length of stay and delay the rehabilitation.

Tranexamic acid, one of antifibrinolytic agents, is a synthetic derivative of the amino acid lysine and acts as a competitive inhibitor in the activation of plasminogen to plasmin, therefore preventing the degradation of fibrin. Shakur et al. reported that the use could reduce mortality in trauma patients. Tranexamic acid has been widely used in elective orthopaedic surgery such as total joint replacement and spine surgery. Several authors reported that tranexamic acid could decreases the blood loss, transfusion rate and cost.

Eligibility criteria: Inclusion Criteria:

* Adults over the age of 60
* Acute isolated intertrochanteric fracture and sub trochanteric fracture treated with short proximal femoral nailing

Exclusion Criteria:

* Use of any anticoagulant at the time of admission
* Documented allergy to tranexamic acid
* History of pulmonary embolism or deep vein thrombosis
* Hepatic failure
* Severe renal insufficiency
* Active coronary artery disease in the past 12 months
* History of cerebrovascular accident in the past 12 months
* Presence of a drug-eluting stent
* Active oncological diseases
* Coagulopathy (international normalised ratio (INR)\>1.4)
* Pathological fractures
* Periprosthetic fractures
* Operation \>2 days from admission

Primary outcomes:
measure: Transfusion rate
timeFrame: Day 3 post operation
measure: Blood loss
timeFrame: Day 3 post operation
Secondary outcomes:
measure: 3 months mortality rate
timeFrame: from post operation to 3 months
measure: Complications
timeFrame: from post operation to 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, The University of Hong Kong
Study officials:
References:
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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.
citation: Lawrence VA, Silverstein JH, Cornell JE, Pederson T, Noveck H, Carson JL. Higher Hb level is associated with better early functional recovery after hip fracture repair. Transfusion. 2003 Dec;43(12):1717-22. doi: 10.1046/j.0041-1132.2003.00581.x.
citation: Zhang P, He J, Fang Y, Chen P, Liang Y, Wang J. Efficacy and safety of intravenous tranexamic acid administration in patients undergoing hip fracture surgery for hemostasis: A meta-analysis. Medicine (Baltimore). 2017 May;96(21):e6940. doi: 10.1097/MD.0000000000006940.
citation: Drakos A, Raoulis V, Karatzios K, Doxariotis N, Kontogeorgakos V, Malizos K, Varitimidis SE. Efficacy of Local Administration of Tranexamic Acid for Blood Salvage in Patients Undergoing Intertrochanteric Fracture Surgery. J Orthop Trauma. 2016 Aug;30(8):409-14. doi: 10.1097/BOT.0000000000000577.
citation: Tengberg PT, Foss NB, Palm H, Kallemose T, Troelsen A. Tranexamic acid reduces blood loss in patients with extracapsular fractures of the hip: results of a randomised controlled trial. Bone Joint J. 2016 Jun;98-B(6):747-53. doi: 10.1302/0301-620X.98B6.36645.