Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced?
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Tranexamic Acid on Blood Loss and Transfusion Need in Patients Operated With a Short Intramedullary Nail, for Pertrochanteric Fractures .|
- Blood transfusions (amount) [ Time Frame: time in hospital (approximately 10 days) ] [ Designated as safety issue: Yes ]The amount of red blood cell transfusions the patient receive pre, peri and postoperatively during their stay in the hospital.
- Hemoglobin [ Time Frame: Time in hospital (approximately 10 days) ] [ Designated as safety issue: No ]The hemoglobin is measured daily, for the whole period.
- Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]Mortality is obtained via central personal registration system (Danish CPR system)
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Patients are given saline instead of tranexamic acid in the placebo group
|Active Comparator: Tranexamic Acid||
Drug: Tranexamic Acid
1 g of tranexamic acid as a bolus immediately before surgery 3 g of tranexamic acid in 24hours postop.
Other Name: Cyklokapron (tranexamic acid)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535781
|Contact: Peter Toft Tengberg T Tengberg, MDemail@example.com|
|Hvidovre, Copenhagen, Denmark, 2650|
|Principal Investigator:||Peter T Tengberg, MD||Hvidovre University Hospital|
|Study Chair:||Henrik Palm, MD||Hvidovre University Hospital|
|Study Director:||Anders Troelsen, PhD||Hvidovre University Hospital|
|Study Chair:||Michael Krasheninnikoff, MD||Hvidovre University Hospital|
|Study Chair:||Nicolai B Foss, PhD, Dr.Med||Hvidovre University Hospital|