Clinical trial NCT00327106: Tranexamic Acid in HIp Fracture Surgery (THIF Study)
Official title: Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hip Fracture
Keywords: hip fracture
transfusion
tranexamic acid
fondaparinux
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2006-05-18
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: number of patients receiving the transfusion of at least one unit of allogeneic red blood cell
timeFrame: between the begining of surgery (day 1) and the eighth post-operative day (day 8)
Secondary outcomes:
measure: number of patients receiving the transfusion of at least one unit of allogeneic red blood cell
timeFrame: 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)
measure: post-operative major hemorrhage
timeFrame: day 8
measure: post-operative blood loss
timeFrame: untill day 8
measure: post-operative bacterial infection (combined criteria of wound infection, bronchopulmonary infection and urinary tract infection)
timeFrame: untill six weeks
measure: thromboembolic events (combined criteria of venous thrombo-embolism, stroke, acute coronary syndrome and peripheral arterial thrombosis)
timeFrame: untill six weeks
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: Chu Saint-Etienne
state: Loire
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Paul Zufferey, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.