Tranexamic Acid in Chinese Elderly Patients With Intertrochanteric Fracture RCT

Fracture of Femur Clinical Trial

Official title:

The Use of Tranexamic Acid in Chinese Elderly Patients Undergoing Femoral Nailing for Intertrochanteric Fracture: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04290884
• Other study ID #: UW 18-038
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 23, 2018
• Est. completion date: May 2020

Study information

• Verified date: March 2020
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: May 2020
• Est. primary completion date: February 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Fracture of Femur
• Fractures, Bone
• Hip Fractures

Intervention

Drug:
• Tranexamic Acid
The recruited patients will be randomly assigned to two groups, 50% chance to the experimental group (use of tranexamic acid) and 50% chance to the control group (use of normal saline). After the reduction of the intertrochanteric fracture, 10ml of tranexamic acid is injected under the deep fascia around the fracture area before inserting a drain. As for the control group, 10ml of normal saline is injected instead. Blood will be taken on the third day post operation, and the patient will be seen at 6 weeks, and 3 months.

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital, The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (7)

Bhaskar D, Parker MJ. Haematological indices as surrogate markers of factors affecting mortality after hip fracture. Injury. 2011 Feb;42(2):178-82. doi: 10.1016/j.injury.2010.07.501. — View 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. — 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

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. — View Citation

Schneider EL, Guralnik JM. The aging of America. Impact on health care costs. JAMA. 1990 May 2;263(17):2335-40. — View 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. Erratum in: Bone Joint J. 2016 Dec;98-B(12 ):1711-1712. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transfusion rate	The total blood transfusion post operation	Day 3 post operation
Primary	Blood loss	Blood loss calculation according to formula of Nadler, Hidalgo and Bloch	Day 3 post operation
Secondary	3 months mortality rate	mortality rate of the patient within post operation 3 months	from post operation to 3 months
Secondary	Complications	Complications related to thrombotic events	from post operation to 3 months