Tranexamic Acid in Chinese Elderly Patients With Intertrochanteric Fracture RCT

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

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.

Study Overview

• Status: Unknown
• Conditions: Fracture of Femur
• Intervention / Treatment: Drug: Tranexamic Acid

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital, the University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Local administration of tranexamic acid; All patients hip fracture will be treated according to the hospital standard procedure; Check complete blood count on admission and Day 3 post-operation.; 10ml tranexamic acid injected under the deep fascia around the fracture site under x-ray control; Sealed envelope system: Operation room nurse will open a sealed envelope for treatment allocation. The medications are prepared by the nurse according to the instruction inside the envelop.; Transfusion when clinically indicated or Hb < 8g/dL; Blood Loss calculation (formula of Nadler, Hidalgo and Bloch); Blood taken at Day 3 post-operation will be used for measure of postoperative haematocrit. By this time postoperatively fluid shift has settled and the patient is haemodynamically stable.; After discharge, patients will be seen in 6 weeks and 3 months	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.; Other Names: Transamin
No Intervention: Control group; All patients hip fracture will be treated according to the hospital standard procedure; Check complete blood count on admission and Day 3 post-operation.; 10ml normal saline injected under the deep fascia around the fracture site under x-ray control; Sealed envelope system: Operation room nurse will open a sealed envelope for treatment allocation. The medications are prepared by the nurse according to the instruction inside the envelop.; Transfusion when clinically indicated or Hb < 8g/dL; Blood Loss calculation (formula of Nadler, Hidalgo and Bloch); Blood taken at Day 3 post-operation will be used for measure of postoperative haematocrit. By this time postoperatively fluid shift has settled and the patient is haemodynamically stable.; After discharge, patients will be seen in 6 weeks and 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfusion rate	The total blood transfusion post operation	Day 3 post operation
Blood loss	Blood loss calculation according to formula of Nadler, Hidalgo and Bloch	Day 3 post operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 months mortality rate	mortality rate of the patient within post operation 3 months	from post operation to 3 months
Complications	Complications related to thrombotic events	from post operation to 3 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Publications and helpful links

General Publications

• 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.
• 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.
• Schneider EL, Guralnik JM. The aging of America. Impact on health care costs. JAMA. 1990 May 2;263(17):2335-40.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2018
• Primary Completion (Actual): February 14, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: elderly; intertrochanteric fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Hip Injuries; Femoral Fractures; Fractures, Bone; Hip Fractures; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: UW 18-038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes