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

This study is currently recruiting participants.
Verified February 2012 by Hvidovre University Hospital
Sponsor:
Information provided by (Responsible Party):
Peter Toft Tengberg, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01535781
First received: November 23, 2011
Last updated: February 15, 2012
Last verified: February 2012
History of Changes
  Purpose

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
Anemia
 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:

U.S. FDA Resources

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)


Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo 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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535781

Contacts
Contact: Peter Toft Tengberg T Tengberg, MD +4561663676 ptofttengberg@gmail.com

Locations
Denmark
Hvidovre Hospital Recruiting
Hvidovre, Copenhagen, Denmark, 2650
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Peter Toft Tengberg, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01535781     History of Changes
Other Study ID Numbers: TA0001
Study First Received: November 23, 2011
Last Updated: February 15, 2012
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:
Anemia
Fractures, Bone
Hemorrhage
Hip Fractures
Hematologic Diseases
Wounds and Injuries
Pathologic Processes
Femoral Fractures
Hip Injuries
Leg Injuries
 Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013