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.
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
|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 .|
- Total Blood Loss [ Time Frame: time in hospital (approximately 10 days) ] [ Designated as safety issue: Yes ]Calculated as described by Foss et al in their study of 2006. "Hidden Blood Loss After Surgery for Hip Fracture" JBJS br. 2006.
- Transfusions [ Time Frame: From admission to third day after surgery. ] [ Designated as safety issue: No ]Information from local blood bank
- Mortality [ Time Frame: 30 days and 90 days follow up ] [ Designated as safety issue: No ]Mortality is obtained via central personal registration system (Danish CPR system)
- Thromboembolic Event (clinical, NOT by routine ultrasound measurement) [ Time Frame: 90 days follow up ] [ Designated as safety issue: Yes ]Obtained in-hospital, through routine check ups daily. After discharge; obtained from patient records.
|Study Start Date:||September 2011|
|Study Completion Date:||August 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Patients are given saline instead of tranexamic acid in the placebo group
Identical syringe and drip used as in the intervention, to ensure blinding.
Other Name: Saline
Active Comparator: Tranexamic Acid
Tranexamic acid; 1 gram as a bolus prior to surgery. 3 grams of Tranexamic acid in 1 liter of saline as a 24 hour infusion.
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
|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|