Tranexamic Acid in Hip Fracture Patients
1 other identifier
interventional
60
1 country
1
Brief Summary
This is a randomized controlled trial comparing the use of tranexamic acid to placebo in patients admitted to hospital with a hip fracture.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2012
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
First Submitted
Initial submission to the registry
March 21, 2011
CompletedFirst Posted
Study publicly available on registry
March 30, 2011
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJune 7, 2012
June 1, 2012
1 year
March 21, 2011
June 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total amount of blood loss per patient from admission to day 5 post-op
5 DAYS
Secondary Outcomes (5)
Number of packed cell transfusion per patient.
5 DAYS
Initial functional outcome and feeling of well-being.
5 days
thromboembolic events
5 days
post-operative bacterial infection
5 days
30 day mortality rate
30 days
Study Arms (3)
Group A
EXPERIMENTALPatients will receive IV Tranexamic acid 1 gram upon diagnosis and consent in the emergency room. A second 1 gram in a slow drip during the next 8 hours.
GROUP B
EXPERIMENTALPatients will receive IV Tranexamic acid 1 gram five minutes before skin incision and a second 1 gram in a slow drip during the next 8 hours.
GROUP C
PLACEBO COMPARATORA control group will only receive placebo in the emergency room and in the OR.
Interventions
GROUP A - receive IV Tranexamic acid 1 gram upon diagnosis and consent in the emergency room. A second 1 gram in a slow drip during the next 8 hours. GROUP B - IV Tranexamic acid 1 gram five minutes before skin incision and a second 1 gram in a slow drip during the next 8 hours. Group C - A control group will only receive placebo in the emergency room and in the OR.
Eligibility Criteria
You may qualify if:
- Patients admitted to the emergency room with proximal hip fractures (31A-31B according to the Muller AO classification of fractures - long bones).
- Patients mentally capable of giving informed consent.
You may not qualify if:
- Vascular events within the last 2 months such as CVA, TIA, ACS, MI, DVT or arterial thrombosis.
- Patients receiving anticoagulation therapy with Coumadin or Plavix.
- Pregnancy and breastfeeding females.
- Previous arterial or venous thrombosis
- History of seizures.
- Creatinine \>2.
- Oestroprogestive therapy.
- Multiple fractures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michal Roll PhD,MBAlead
- Tel-Aviv Sourasky Medical Centercollaborator
Study Sites (1)
Sourasky Medical Center
Tel Aviv, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ELI SHTEINBERG, MD
Tel-Aviv Sourasky Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- division of research and development TASMC
Study Record Dates
First Submitted
March 21, 2011
First Posted
March 30, 2011
Study Start
June 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
June 7, 2012
Record last verified: 2012-06