NCT01535781

Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced?

Effect of Tranexamic Acid on Blood Loss and Transfusion Need in Patients Operated With a Short Intramedullary Nail, for Pertrochanteric Fractures .

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The effect of Tranexamic acid on blood loss, hemoglobin and transfusions in patients with pertrochanteric hip fractures. Tranexamic acid is a well known drug used in many types of surgery. The investigators wish to investigate if the use of tranexamic acid can reduce the peri- and post-operative blood loss in patients who undergo surgery with a short intramedullary nail, for a pertrochanteric hip fracture. An interim analysis was planned when reaching 60 inclusions. The interim analysis was conducted only on the primary outcome (TBL). A difference in TBL of no less than 500 ml was considered a reason to halt the study. The 0.001 level was chosen as a simple approach to this interim analysis from the Haybittle-Peto boundary

Detailed description

Studies have shown that hip fractures have a hidden blood loss besides the recorded perioperative blood loss. Patients who are osteosynthesised with an intramedullary nail have been shown to have the largest hidden blood loss. Postoperative anaemia is associated with a higher morbidity and mortality. We wish to investigate the possibility of reducing this hidden blood loss, with the use of a well known drug (tranexamic acid) that is widely used to reduce blood loss in other forms of surgery and in multitraumatized patients.

Conditions

• Hip Fracture
• Anemia

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	1 g of tranexamic acid as a bolus immediately before surgery 3 g of tranexamic acid in 24hours postop.
DRUG	Placebo	Identical syringe and drip used as in the intervention, to ensure blinding.

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-06-01
• Completion: 2014-08-01
• First posted: 2012-02-20
• Last updated: 2015-02-05

Locations

1 site across 1 country: Denmark