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

This study has been terminated.
(The recruting of patients was much slower than anticipated and the departments economy could no longer afford the extra staff needed to complete the study.)
Information provided by (Responsible Party):
Peter Toft Tengberg, Hvidovre University Hospital Identifier:
First received: November 23, 2011
Last updated: August 10, 2014
Last verified: August 2014

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.

Condition Intervention
Hip Fracture
Drug: Tranexamic Acid
Drug: Placebo

Study Type: Interventional
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 .

Resource links provided by NLM:

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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)

Enrollment: 73
Study Start Date: September 2011
Study Completion Date: August 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Patients are given saline instead of tranexamic acid in the placebo group
Drug: Placebo
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)

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01535781

Hvidovre Hospital
Hvidovre, Copenhagen, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
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
  More Information

No publications provided

Responsible Party: Peter Toft Tengberg, MD, Hvidovre University Hospital Identifier: NCT01535781     History of Changes
Other Study ID Numbers: TA0001
Study First Received: November 23, 2011
Last Updated: August 10, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
pertrochanteric fracture
tranexamic acid
postoperative blood loss
blood loss
hidden blood loss
blood transfusions

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries
Pathologic Processes
Wounds and Injuries
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 27, 2014