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 .

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 Overview

• Status: Terminated
• Conditions: Anemia; Hip Fracture
• Intervention / Treatment: Drug: Placebo; Drug: Tranexamic Acid

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Hvidovre, Copenhagen, Denmark, 2650
      • Hvidovre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Patients are given saline instead of tranexamic acid in the placebo group	Drug: Placebo; Identical syringe and drip used as in the intervention, to ensure blinding.; Other Names: 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 Names: Cyklokapron (tranexamic acid)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: November 23, 2011
• First Submitted That Met QC Criteria: February 15, 2012
• First Posted (Estimate): February 20, 2012

Study Record Updates

• Last Update Posted (Estimate): February 5, 2015
• Last Update Submitted That Met QC Criteria: February 3, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: blood loss; blood transfusions; tranexamic acid; pertrochanteric fracture; postoperative blood loss; hidden blood loss
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hemorrhage; Fractures, Bone; Hip Fractures; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: TA0001