Tranexamic Acid in HIp Fracture Surgery (THIF Study)
THIF
Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery.
2 other identifiers
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2005
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
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 17, 2006
CompletedFirst Posted
Study publicly available on registry
May 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedJune 11, 2009
June 1, 2009
1.8 years
May 17, 2006
June 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of patients receiving the transfusion of at least one unit of allogeneic red blood cell
between the begining of surgery (day 1) and the eighth post-operative day (day 8)
Secondary Outcomes (5)
number of patients receiving the transfusion of at least one unit of allogeneic red blood cell
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)
post-operative major hemorrhage
day 8
post-operative blood loss
untill day 8
post-operative bacterial infection (combined criteria of wound infection, bronchopulmonary infection and urinary tract infection)
untill six weeks
thromboembolic events (combined criteria of venous thrombo-embolism, stroke, acute coronary syndrome and peripheral arterial thrombosis)
untill six weeks
Study Arms (2)
1
ACTIVE COMPARATORExacyl
2
PLACEBO COMPARATORPhysiologic serum
Interventions
15 mg/kg IV (in the vein), just before surgery and 3 hours after surgery
Eligibility Criteria
You may qualify if:
- Patient requiring surgery for an isolated hip fracture of less than 48 hours
You may not qualify if:
- Contraindication to tranexamic acid
- Contraindication to fondaparinux
- Contraindication to general anesthesia associated with a femoral nerve block
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu Saint-Etienne
Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055, France
Related Publications (1)
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.
PMID: 19926634DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Zufferey, Doctor
CHU SAINT-ETIENNE
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 17, 2006
First Posted
May 18, 2006
Study Start
April 1, 2005
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
June 11, 2009
Record last verified: 2009-06