Single Dose of Tranexamic Acid and Blood Loss, in Elderly Patients With Hip Fracture
1 other identifier
interventional
200
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2013
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 29, 2016
CompletedFirst Posted
Study publicly available on registry
August 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedAugust 16, 2017
August 1, 2017
4.9 years
November 29, 2016
August 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
number of transfusions of allogeneic RBC from surgery up to day 4
5 days
total blood loss from surgery to day
5 days
Secondary Outcomes (2)
incidence of vascular events
3 months
Incidence of deaths
3 months
Study Arms (2)
Group 1
ACTIVE COMPARATORintravenous tranexamic acid, 15mg/kg, preoperatively, single dose
Group 2
PLACEBO COMPARATORIntravenous normal saline, 100mg, preoperatively, single dose
Interventions
Tranexamic Acid 15mg/kg , administered intravenously, preoperatively, in a single dose
Normal Saline, 100mg, administered intravenously, preoperatively in single dose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
2nd Department of Orthopaedics
Athens, Attica, 14233, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Orthopaedics
Study Record Dates
First Submitted
November 29, 2016
First Posted
August 16, 2017
Study Start
January 1, 2013
Primary Completion
December 1, 2017
Study Completion
February 1, 2018
Last Updated
August 16, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share