Does Tranexamic Acid Reduce the Need for Blood Transfusions in Patients Undergoing Hip Fracture Surgery?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark Pagnano, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01714336
First received: October 23, 2012
Last updated: April 8, 2016
Last verified: April 2016
Results First Received: April 8, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Hip Fracture
Interventions: Drug: tranexamic acid
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo

Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.

placebo: A similar dose of 0.9% sodium chloride (NaCL) will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.

Tranexamic Acid

Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.

tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.


Participant Flow:   Overall Study
    Placebo     Tranexamic Acid  
STARTED     69     69  
COMPLETED     69     69  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Placebo

Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.

placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.

Tranexamic Acid

Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.

tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.

Total Total of all reporting groups

Baseline Measures
    Placebo     Tranexamic Acid     Total  
Number of Participants  
[units: participants]
  69     69     138  
Age  
[units: years]
Mean (Standard Deviation)
  82.2  (10)     81.0  (10)     81.6  (10)  
Gender  
[units: participants]
     
Female     47     48     95  
Male     22     21     43  
Region of Enrollment  
[units: participants]
     
United States     69     69     138  



  Outcome Measures
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1.  Primary:   Number of Participants Who Received a Hospitalization Transfusion   [ Time Frame: 5 days ]

2.  Secondary:   Mean Number of Units Transfused   [ Time Frame: 5 days ]

3.  Secondary:   Calculated Blood Loss   [ Time Frame: 5 days ]

4.  Secondary:   Number of Participants With Venous Thromboembolism (VTE) Diagnosis   [ Time Frame: Within 6 months of surgery ]

5.  Secondary:   Number of Participants With Wound Complications   [ Time Frame: Within 6 months of surgery ]

6.  Secondary:   Number of Participants With Myocardial Infarction (MI) Diagnosis   [ Time Frame: Within 6 months of surgery ]

7.  Secondary:   Number of Participants With Cerebrovascular Accident (CVA) Diagnosis   [ Time Frame: Within 6 months of surgery ]

8.  Secondary:   Number of Participants Who Died   [ Time Frame: 6 months after surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Mark Pagnano
Organization: Mayo Clinic
phone: 507-284-2511
e-mail: pagnano.mark@mayo.edu



Responsible Party: Mark Pagnano, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01714336     History of Changes
Other Study ID Numbers: 12-004599
Study First Received: October 23, 2012
Results First Received: April 8, 2016
Last Updated: April 8, 2016
Health Authority: United States: Food and Drug Administration