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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hip Fracture, Anemia

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients planned to undergo osteosynthesis with short intramedullary nail for a pertrochanteric hip fracture. ASA score 3, 2 or 1 Exclusion Criteria: Allergy for tranexamic acid Clinical signs of acute thromboembolic event Renal function impairment (S-creatinin>120micromol/l) Active thrombotic disease or DIC K-vitamin antagonist treatment Malignancy Pathological fracture Previously operated in same hip BW > 100kg

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Patients are given saline instead of tranexamic acid in the placebo group | Drug: Placebo<br>* Identical syringe and drip used as in the intervention, to ensure blinding.<br>* Other names: Saline;|
| Active Comparator: Tranexamic Acid<br>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<br>* 1 g of tranexamic acid as a bolus immediately before surgery 3 g of tranexamic acid in 24hours postop.<br>* Other names: Cyklokapron (tranexamic acid);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Blood Loss | Calculated as described by Foss et al in their study of 2006. Hidden Blood Loss After Surgery for Hip Fracture JBJS br. 2006. | time in hospital (approximately 10 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusions | Information from local blood bank | From admission to third day after surgery. | 
| Mortality | Mortality is obtained via central personal registration system (Danish CPR system) | 30 days and 90 days follow up | 
| Thromboembolic Event (clinical, NOT by routine ultrasound measurement) | Obtained in-hospital, through routine check ups daily. After discharge; obtained from patient records. | 90 days follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood loss, pertrochanteric fracture, tranexamic acid, postoperative blood loss, hidden blood loss, blood transfusions