One Versus Two Doses of Tranexamic Acid in Surgically Treated Extracapsular Hip Fractures

NCT07432737 | Recruiting

• 1 other identifier: EC-02-475/6
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether giving one dose or two doses of tranexamic acid can safely lower blood loss in older adults having surgery for certain hip fractures. The study includes adults aged 65 years or older who need surgery for pertrochanteric or subtrochanteric hip fractures. The main questions the study aims to answer are:

• Does giving two doses of tranexamic acid lower the need for blood transfusions compared to one dose?
• Does tranexamic acid help keep hemoglobin levels higher after surgery?
• Is tranexamic acid safe in this group of participants? Researchers will compare participants who receive one dose of tranexamic acid with those who receive two doses to see which approach works better and is safe. Participants will:
• Receive either one dose of tranexamic acid before surgery or two doses, one before and one after surgery
• Have standard surgery to fix their hip fracture within 48 hours of hospital admission
• Be monitored during their hospital stay for blood loss, transfusions, and medical problems
• Be followed for up to 90 days after surgery to check for safety A total of 120 participants will take part in this study, which is being conducted at the University Clinic "St. Naum Ohridski" in Skopje, North Macedonia.

Conditions

Hip Fractures

Keywords

tranexamic acid; blood loss; blood transfusion; safety

Outcome Measures

Primary Outcomes (1)

• Incidence of allogeneic blood transfusion

  Comparison of the incidence of intraoperative and postoperative allogeneic transfusions (≥1 unit of red blood cells) between patients receiving a single intravenous dose of tranexamic acid (15 mg/kg, pre-incision) and those receiving two doses (15 mg/kg pre-incision + 15 mg/kg 3 hours after the first dose).

  From start of surgery through postoperative day 5.

Secondary Outcomes (7)

• Hemoglobin drop

  Preoperative to postoperative day 3

• Total and hidden blood loss

  From start of surgery through postoperative day 3

• Volume of transfused blood products

  From start of surgery through postoperative day 5.

• Length of hospital stay

  From surgery through hospital discharge up to 30 days postoperatively

• Incidence of thrombotic events

  Up to 90 days postoperatively

Study Arms (2)

Group A: Single-Dose TXA

ACTIVE COMPARATOR

Patients will receive a single intravenous dose of 15 mg/kg Tranexamic Acid 10-20 minutes before the surgical incision, followed by a placebo(saline solution) 3 hours later.

Drug: Tranexamic acid

Group B: Two-Dose TXA

EXPERIMENTAL

Patients will receive a 15 mg/kg intravenous dose of Tranexamic acid 10-20 minutes before the surgical incision and a second intravenous dose of 15 mg/kg Tranexamic Acid 3 hours after the first dose

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

15 mg/kg intravenous solution (100 mg/ml)

Group A: Single-Dose TXA; Group B: Two-Dose TXA

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Written informed consent obtained
• Patients aged 65 years or older
• Patients with pertrochanteric femoral fracture (AO/OTA classification: 31A1.2, 31A1.3, 31A2, 31A3) or subtrochanteric femoral fracture (AO/OTA classification: 32; fractures from the level of the lesser trochanter to 5 cm distally)
• Surgical treatment performed within 48 hours of hospital admission

You may not qualify if:

• Age younger than 65 years
• Known allergy or hypersensitivity to tranexamic acid
• Active thromboembolic event (deep vein thrombosis, arterial thrombosis, pulmonary embolism) or history of vascular event within the past year (myocardial infarction, coronary or peripheral vascular stenting, thromboembolism, stroke)
• Impaired renal function defined as serum creatinine \>120 µmol/L in the last preoperative laboratory test
• History of malignant disease
• History of seizure disorder or chronic anticonvulsant therapy
• Polytrauma or multiple trauma
• More than one fracture
• Previous fracture of the same hip
• Preoperative hemoglobin level \<8 g/dL (last laboratory test before surgery)
• Thrombocytopenia or other coagulation disorders
• Treatment with vitamin K antagonists with INR \>1.5
• Treatment with low-molecular-weight heparins without appropriate preoperative discontinuation according to clinical protocol (usually ≥24 hours for prophylactic doses and ≥24-36 hours for therapeutic doses)
• Treatment with direct oral anticoagulants without appropriate preoperative discontinuation (usually 24-48 hours, depending on renal function and bleeding risk)
• Treatment with P2Y12 inhibitors (e.g., ticagrelor, clopidogrel, prasugrel) when, according to anesthesiologist assessment, surgery cannot be safely performed within 48 hours

Sponsors & Collaborators

• University Hospital for Surgical Diseases St. Naum Ohridsk i- Skopje: lead

Study Sites (1)

University Clinic PHI University Clinic for Surgical Diseases, St. Naum Ohridski

Skopje, 1000, North Macedonia

RECRUITING

Related Publications (14)

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• Ali Algadiem E, Aleisa AA, Alsubaie HI, Buhlaiqah NR, Algadeeb JB, Alsneini HA. Blood Loss Estimation Using Gauze Visual Analogue. Trauma Mon. 2016 May 3;21(2):e34131. doi: 10.5812/traumamon.34131. eCollection 2016 May.

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• Jiang J, Xing F, Zhe M, Luo R, Xu J, Duan X, Xiang Z. Efficacy and safety of tranexamic acid for patients with intertrochanteric fractures treated with intramedullary fixation: A systematic review and meta-analysis of current evidence in randomized controlled trials. Front Pharmacol. 2022 Sep 19;13:945971. doi: 10.3389/fphar.2022.945971. eCollection 2022.

  PMID: 36199695 RESULT

• Masouros P, Antoniou G, Nikolaou VS. Efficacy and safety of tranexamic acid in hip fracture surgery. How does dosage affect outcomes: A meta-analysis of randomized controlled trials. Injury. 2022 Feb;53(2):294-300. doi: 10.1016/j.injury.2021.09.063. Epub 2021 Oct 12.

  PMID: 34689986 RESULT

• Zhang J, Fan X, Zheng Y, Wu J, Yuan X. Intravenous application of tranexamic acid in intramedullary nailing for the treatment of geriatric intertrochanteric fractures: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2023 Jul 27;24(1):614. doi: 10.1186/s12891-023-06725-y.

  PMID: 37501145 RESULT

• Leverett GD, Marriott A. Intravenous tranexamic acid and thromboembolic events in hip fracture surgery: A systematic review and meta-analysis. Orthop Traumatol Surg Res. 2023 Apr;109(2):103337. doi: 10.1016/j.otsr.2022.103337. Epub 2022 May 25.

  PMID: 35643364 RESULT

• Augustinus S, Mulders MAM, Gardenbroek TJ, Goslings JC. Tranexamic acid in hip hemiarthroplasty surgery: a systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2023 Jun;49(3):1247-1258. doi: 10.1007/s00068-022-02180-x. Epub 2022 Dec 13.

  PMID: 36512031 RESULT

• Yang YZ, Cheng QH, Zhang AR, Yang X, Zhang ZZ, Guo HZ. Efficacy and safety of single- and double-dose intravenous tranexamic acid in hip and knee arthroplasty: a systematic review and meta-analysis. J Orthop Surg Res. 2023 Aug 10;18(1):593. doi: 10.1186/s13018-023-03929-9.

  PMID: 37563702 RESULT

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  PMID: 29384974 RESULT

• CRASH-3 trial collaborators. Effects of tranexamic acid on death, disability, vascular occlusive events and other morbidities in patients with acute traumatic brain injury (CRASH-3): a randomised, placebo-controlled trial. Lancet. 2019 Nov 9;394(10210):1713-1723. doi: 10.1016/S0140-6736(19)32233-0. Epub 2019 Oct 14.

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  PMID: 19926634 RESULT

• Sing CW, Lin TC, Bartholomew S, Bell JS, Bennett C, Beyene K, Bosco-Levy P, Bradbury BD, Chan AHY, Chandran M, Cooper C, de Ridder M, Doyon CY, Droz-Perroteau C, Ganesan G, Hartikainen S, Ilomaki J, Jeong HE, Kiel DP, Kubota K, Lai EC, Lange JL, Lewiecki EM, Lin J, Liu J, Maskell J, de Abreu MM, O'Kelly J, Ooba N, Pedersen AB, Prats-Uribe A, Prieto-Alhambra D, Qin SX, Shin JY, Sorensen HT, Tan KB, Thomas T, Tolppanen AM, Verhamme KMC, Wang GH, Watcharathanakij S, Wood SJ, Cheung CL, Wong ICK. Global Epidemiology of Hip Fractures: Secular Trends in Incidence Rate, Post-Fracture Treatment, and All-Cause Mortality. J Bone Miner Res. 2023 Aug;38(8):1064-1075. doi: 10.1002/jbmr.4821. Epub 2023 May 29.

  PMID: 37118993 RESULT

MeSH Terms

Conditions

Hip Fractures; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Angelina Krsteva, MD

CONTACT

+38971790239; drangelinakrsteva@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking Participants will be randomly assigned to one of two groups using computer-generated random numbers with 1:1 allocation. Allocation results will be sealed in opaque envelopes and opened by the anesthesiology nurse immediately before surgery. The surgical team and patients will be fully blinded. Tranexamic acid and placebo will be prepared in identical syringes (same volume, color, and appearance) so that neither the surgical team nor the patient knows the assigned treatment. One group will receive a single dose of tranexamic acid before incision and placebo three hours later, while the other group will receive two doses of tranexamic acid, before incision and three hours postoperatively.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Prospective, randomized, single-center clinical study

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 25, 2026
• Study Start: February 17, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)