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Tranexamic Acid in HIp Fracture Surgery (THIF Study) (THIF)

Primary Purpose

Hip Fracture

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Tranexamic acid (Exacyl)
Placebo
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture focused on measuring hip fracture, transfusion, tranexamic acid, fondaparinux

Eligibility Criteria

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

Inclusion Criteria: Patient requiring surgery for an isolated hip fracture of less than 48 hours Exclusion Criteria: Contraindication to tranexamic acid Contraindication to fondaparinux Contraindication to general anesthesia associated with a femoral nerve block pregnancy

Sites / Locations

  • Chu Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Exacyl

Physiologic serum

Outcomes

Primary Outcome Measures

number of patients receiving the transfusion of at least one unit of allogeneic red blood cell

Secondary Outcome Measures

number of patients receiving the transfusion of at least one unit of allogeneic red blood cell
post-operative major hemorrhage
post-operative blood loss
post-operative bacterial infection (combined criteria of wound infection, bronchopulmonary infection and urinary tract infection)
thromboembolic events (combined criteria of venous thrombo-embolism, stroke, acute coronary syndrome and peripheral arterial thrombosis)

Full Information

First Posted
May 17, 2006
Last Updated
June 9, 2009
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT00327106
Brief Title
Tranexamic Acid in HIp Fracture Surgery (THIF Study)
Acronym
THIF
Official Title
Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy of tranexamic acid in hip fracture surgery on the reduction of allogeneic red blood cell transfusion.
Detailed Description
Studies in hip and knee arthroplasty (scheduled surgery) have shown that tranexamic acid decreases allogeneic red blood cell transfusion. In hip fracture surgery, an emergent procedure, transfusion is frequent. Transfusion increases adverse events such as postoperative bacterial infection and venous thrombosis. The purpose of this study is to assess the efficacy of tranexamic acid, an anti-fibrinolytic agent, in hip fracture surgery on the reduction of allogeneic red blood cell transfusion. The trial will also evaluate if the reduction in transfusion will be associated with less postoperative infection and without an increase in the thrombotic risk. Patients with an isolated hip fracture of less than 48 hours will be randomized to either tranexamic acid 15mg/kg IV at skin incision and three hours later or saline.Patients will receive fondaparinux for prophylaxis of venous thrombosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
hip fracture, transfusion, tranexamic acid, fondaparinux

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Exacyl
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Physiologic serum
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid (Exacyl)
Other Intervention Name(s)
Exacyl
Intervention Description
15 mg/kg IV (in the vein), just before surgery and 3 hours after surgery
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
NaCl 9‰, 0,15 ml/kg IV (in the vein), just before surgery and 3 hours after surgery.
Primary Outcome Measure Information:
Title
number of patients receiving the transfusion of at least one unit of allogeneic red blood cell
Time Frame
between the begining of surgery (day 1) and the eighth post-operative day (day 8)
Secondary Outcome Measure Information:
Title
number of patients receiving the transfusion of at least one unit of allogeneic red blood cell
Time Frame
between the administration of fondaparinux for venous thrombosis prophylaxis(8 hours after end of surgery on day 1) and the eighth post-operative day (day 8)
Title
post-operative major hemorrhage
Time Frame
day 8
Title
post-operative blood loss
Time Frame
untill day 8
Title
post-operative bacterial infection (combined criteria of wound infection, bronchopulmonary infection and urinary tract infection)
Time Frame
untill six weeks
Title
thromboembolic events (combined criteria of venous thrombo-embolism, stroke, acute coronary syndrome and peripheral arterial thrombosis)
Time Frame
untill six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient requiring surgery for an isolated hip fracture of less than 48 hours Exclusion Criteria: Contraindication to tranexamic acid Contraindication to fondaparinux Contraindication to general anesthesia associated with a femoral nerve block pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Zufferey, Doctor
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint-Etienne
City
Saint-etienne
State/Province
Loire
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
19926634
Citation
Zufferey PJ, Miquet M, Quenet S, Martin P, Adam P, Albaladejo P, Mismetti P, Molliex S; tranexamic acid in hip-fracture surgery (THIF) study. Tranexamic acid in hip fracture surgery: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):23-30. doi: 10.1093/bja/aep314.
Results Reference
derived

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Tranexamic Acid in HIp Fracture Surgery (THIF Study)

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