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Tranexamic Acid in Hip Fracture Patients

Primary Purpose

Closed Fracture of Hip

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Tranexamic acid
Sponsored by
Michal Roll PhD,MBA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Closed Fracture of Hip focused on measuring proximal, hip, fractures

Eligibility Criteria

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  1. Vascular events within the last 2 months such as CVA, TIA, ACS, MI, DVT or arterial thrombosis.
  2. Patients receiving anticoagulation therapy with Coumadin or Plavix.
  3. Pregnancy and breastfeeding females.
  4. Previous arterial or venous thrombosis
  5. History of seizures.
  6. Creatinine >2.
  7. Oestroprogestive therapy.
  8. Multiple fractures.

Sites / Locations

  • Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Group A

GROUP B

GROUP C

Arm Description

Patients 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.

Patients 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.

A control group will only receive placebo in the emergency room and in the OR.

Outcomes

Primary Outcome Measures

Total amount of blood loss per patient from admission to day 5 post-op

Secondary Outcome Measures

Number of packed cell transfusion per patient.
Initial functional outcome and feeling of well-being.
thromboembolic events
post-operative bacterial infection
30 day mortality rate

Full Information

First Posted
March 21, 2011
Last Updated
June 6, 2012
Sponsor
Michal Roll PhD,MBA
Collaborators
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01326403
Brief Title
Tranexamic Acid in Hip Fracture Patients
Official Title
Tranexamic Acid in Hip Fracture Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michal Roll PhD,MBA
Collaborators
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
transfusion of allogeneic RBC's is not free of adverse events and has been associated with an increased risk of postoperative infection Tranexamic acid in trauma patients has been shown to reduce 30-day mortality. Hospital trauma protocol includes tranexamic acid in patients with major bleeding. Tranexamic acid in orthopedic elective joint reconstruction surgery has been shown to substantially decrease bleeding in knee and hip arthroplasty. in hip fracture surgery, transexamic acid reduces erythrocyte transfusion rate but may promote a hypercoagulable state. Tranexamic acid is an antifibrinolytic drug that inhibits plasminogen from turning into plasmin thereby inhibiting clot breakdown.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Closed Fracture of Hip
Keywords
proximal, hip, fractures

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Patients 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.
Arm Title
GROUP B
Arm Type
Experimental
Arm Description
Patients 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.
Arm Title
GROUP C
Arm Type
Placebo Comparator
Arm Description
A control group will only receive placebo in the emergency room and in the OR.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
placebo group, post injury group, preoperative group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total amount of blood loss per patient from admission to day 5 post-op
Time Frame
5 DAYS
Secondary Outcome Measure Information:
Title
Number of packed cell transfusion per patient.
Time Frame
5 DAYS
Title
Initial functional outcome and feeling of well-being.
Time Frame
5 days
Title
thromboembolic events
Time Frame
5 days
Title
post-operative bacterial infection
Time Frame
5 days
Title
30 day mortality rate
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ELI SHTEINBERG, MD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ELI STEINBERG, MD
Phone
0524266346
Email
STEINBERGE@TASMC.HEALTH.GOV.IL
First Name & Middle Initial & Last Name & Degree
AMIR SHLAIFER, MD
Phone
0527360803
Email
SHLAIFER.MD@GMAIL.COM

12. IPD Sharing Statement

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Tranexamic Acid in Hip Fracture Patients

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