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

Primary Purpose

Blood Loss, Surgical, Hip Fractures, Complication, Postoperative

Status
Unknown status
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Tranexamic Acid 15mg/kg , iv, Single Dose
Normal Saline, 100mg, iv, Singe dose
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Loss, Surgical focused on measuring tranexamic acid, blood tranfusion, hip fractures, elderly, blood loss

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • 2nd Department of OrthopaedicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

intravenous tranexamic acid, 15mg/kg, preoperatively, single dose

Intravenous normal saline, 100mg, preoperatively, single dose

Outcomes

Primary Outcome Measures

number of transfusions of allogeneic RBC from surgery up to day 4
total blood loss from surgery to day

Secondary Outcome Measures

incidence of vascular events
Incidence of deaths

Full Information

First Posted
November 29, 2016
Last Updated
August 15, 2017
Sponsor
National and Kapodistrian University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT03251469
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical, Hip Fractures, Complication, Postoperative
Keywords
tranexamic acid, blood tranfusion, hip fractures, elderly, blood loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
intravenous tranexamic acid, 15mg/kg, preoperatively, single dose
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Intravenous normal saline, 100mg, preoperatively, single dose
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid 15mg/kg , iv, Single Dose
Intervention Description
Tranexamic Acid 15mg/kg , administered intravenously, preoperatively, in a single dose
Intervention Type
Drug
Intervention Name(s)
Normal Saline, 100mg, iv, Singe dose
Intervention Description
Normal Saline, 100mg, administered intravenously, preoperatively in single dose
Primary Outcome Measure Information:
Title
number of transfusions of allogeneic RBC from surgery up to day 4
Time Frame
5 days
Title
total blood loss from surgery to day
Time Frame
5 days
Secondary Outcome Measure Information:
Title
incidence of vascular events
Time Frame
3 months
Title
Incidence of deaths
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vasileios S Nikolaou, MD
Phone
+306932543400
Email
vassilios.nikolaou@gmail.com
Facility Information:
Facility Name
2nd Department of Orthopaedics
City
Athens
State/Province
Attika
ZIP/Postal Code
14233
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vasileios Nikolaou, MD
Phone
+306932543400
Email
vassilios.nikolaou@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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