The Effect of Tranexamic Acid in Total Blood Loss During Proximal Femoral Nailing

NCT05359172 | Completed

• 1 other identifier: HAS2022-21
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Blood loss is an important issue following intertrochanteric femoral fracture and may lead to requiring blood transfusions and transfusion complications. Tranexamic acid is a commonly used drug to decrease blood loss and the number of transfusions. The aim of our study is to determine the effectiveness of tranexamic acid use to reduce total blood loss during proximal femoral nailing for the intertrochanteric femoral fracture in the elderly. Patients aged \>65 years and diagnosed with intertrochanteric fracture will be included in the study. The patients will be numbered according to the admission to the hospital and randomly divided into two groups. First group will receive tranexamic acid infusion and second group will not receive tranexamic acid infusion. Total blood loss will be calculated using Nadler formula. The primary outcome of the study is total blood loss. The secondary outcomes are a number of transfusions, and surgical blood loss during the operative procedure.

Conditions

Hip Fractures; Intertrochanteric Fractures; Blood Loss

Outcome Measures

Primary Outcomes (1)

• Total blood loss

  Estimated total blood loss (L) =Blood volume × (Hctpreop -Hctpostop) /\[(Hctpreop +Hctpostop)/2\]

  2 days

Secondary Outcomes (1)

• number of transfusions

  postroperative first month

Study Arms (2)

Tranexamic acid

They will receive preoperative intravenous tranexamic acid infusions.

Drug: Tranexamic acid

Controls

They will not receive intravenous tranexamic acid infusions.

Interventions

Tranexamic acid DRUG

preoperative intravenous infusion

Tranexamic acid

Eligibility Criteria

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

Study Population

patients who have intertrochanteric femoral fracture and will be treated using closed reduction and proximal femoral nailing

You may qualify if:

• Patients aged ≥ 65 years with intertrochanteric fracture
• Treated with closed reduction and proximal femoral nailing
• Injury time ≤ 8 h.

You may not qualify if:

• Having undergone previous surgery on the same hip,
• Fracture requiring open reduction,
• Having any contraindications for the use of tranexamic acid
• Patients with recent or ongoing thromboembolic events
• Patients who were recently taking or who were taking anticoagulation therapy and platelet aggregation inhibitors;
• Patients with disseminated intravascular coagulation or patients had hepatic or renal diseases with impairment of coagulation function.

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki TRH

Istanbul, Sultangazi, 34000, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 26978136 BACKGROUND

• 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.

  PMID: 27235515 BACKGROUND

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 3, 2022
• Study Start: April 1, 2021
• Primary Completion: July 9, 2022
• Study Completion: July 10, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)