Have you or your loved ones been diagnosed with blood loss, surgical?

You may be eligible to participate in a blood loss, surgical clinical trial.

Have you or your loved ones been diagnosed with blood loss, surgical? You may be eligible to participate in a blood loss, surgical clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Blood Loss, Surgical Clinical Trial in Athens Attika

NCT03251469 | Phase 2 | Interventional

Have you or your loved ones been diagnosed with blood loss, surgical?

You may be eligible to participate in a blood loss, surgical clinical trial.

Have you or your loved ones been diagnosed with blood loss, surgical? You may be eligible to participate in a blood loss, surgical clinical trial.

Recruiting

Male & Female

75 Years +

This study is looking to recruit 200 Participants

The aim of this study is to investigate the hypothesis that single dose of tranexamic acid (TXA) preoperatively will lower blood loss and transfusion rate in elderly patients with hip fractures (intertrochanteric or Subcapital), that will be treated with intramedullary nailing and cemented hemiarthroplasty respectively. After application of inclusion and exclusion criteria, patients will be randomized in two groups. Group 1 will include patients that receive preoperatively single dose of TXA (15mg/kg) and Group 2 will include patients that receive normal saline (control group).

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Details for the study

Brief Title

Single Dose of Tranexamic Acid and Blood Loss, in Elderly Patients With Hip Fracture

Official Title

Single Dose of Tranexamic Acid at the Time of Surgery and Blood Loss, in Elderly Patients Undergoing Hip Fracture Surgery

Brief Summary

The aim of this study is to investigate the hypothesis that single dose of tranexamic acid (TXA) preoperatively will lower blood loss and transfusion rate in elderly patients with hip fractures (intertrochanteric or Subcapital), that will be treated with intramedullary nailing and cemented hemiarthroplasty respectively. After application of inclusion and exclusion criteria, patients will be randomized in two groups. Group 1 will include patients that receive preoperatively single dose of TXA (15mg/kg) and Group 2 will include patients that receive normal saline (control group).

Treatments and/or Procedures

Tranexamic acid 15mg kg iv single dose

Tranexamic Acid 15mg/kg , administered intravenously, preoperatively, in a single dose

Normal saline 100mg iv singe dose

Normal Saline, 100mg, administered intravenously, preoperatively in single dose

Study Criteria

Inclusion Criteria:

  -  Consecutive elderly patients (age >75 yo) undergoing hip fracture surgery for a stable
     or unstable intertrochanteric hip fracture with the insertion of a short
     intramedullary nail (IMN) as well as patients treated surgically with cemented
     hemiarthroplasty for acute femoral neck (subcapital) hip fracture.

Exclusion Criteria:

  -  Any contraindication for tranexamic acid

  -  Multiple fractures

  -  Requirement for anticoagulant therapy that could not be stopped.

  -  Ongoing thromboembolic event

  -  reduced kidney function

  -  malignancy,

  -  pathological fracture

  -  previous operation on the affected hip

  -  Active coronary artery disease (event in the past 12 months).