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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01714336
Other study ID # 12-004599
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2012
Est. completion date October 2015

Study information

Verified date November 2018
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Does tranexamic acid improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.


Description:

Antifibrinolytic medications such as tranexamic acid, aprotinin, and aminocaproic acid have proven to be useful in decreasing blood loss and the proportion of patients who require transfusion after a number of surgical procedures. In orthopedic surgery, tranexamic acid (TXA) is the best studied of these medications and a recent Cochrane Database review determined that tranexamic acid was effective in decreasing perioperative bleeding and post-operative transfusion after elective hip replacement and knee replacement surgery. At Mayo Clinic Rochester, the routine administration of tranexamic acid has evolved over the past decade to become part of the typical protocol for more than 3,000 elective hip and knee replacement procedures each year. Recent administrative data provides fairly compelling evidence of the efficacy of tranexamic acid in decreasing transfusion at the Mayo Clinic Rochester practice with 2010 data showing 2% and 7% prevalence of transfusion in patients treated with tranexamic acid versus 18% and 33% prevalence in those knee and hip replacement patients, respectively, who were not treated with tranexamic acid. A recent analysis of the Mayo Clinic Rochester orthopedic practice showed that patients treated for hip fracture remain at substantial risk of perioperative transfusion (30% prevalence) after operative management. This raises the question as to whether tranexamic acid could improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.


Recruitment information / eligibility

Status Completed
Enrollment 138
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria

- AO/OTA (Orthopedic Trauma Association) fracture classification 31B

- Surgically treated with either hemiarthroplasty or total hip arthroplasty

- Acute fracture treated within 72 hours of injury

- Low energy isolated injury

- Age greater than 18 years old

Exclusion Criteria

- Transfusion received during admission, prior to surgery

- Creatinine clearance less than 30 mL/min

- History of unprovoked Venous Thromboembolism (VTE) and/or recurrent VTE

- Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant

- Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential)

- History of cerebrovascular accident (CVA), Myocardial infarction (MI), or VTE within the previous 30 days

- Coronary stent placement within the previous 6 months

- Disseminated intravascular coagulation

- Subarachnoid hemorrhage

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.
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.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Who Received a Hospitalization Transfusion Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission 5 days
Secondary Mean Number of Units Transfused Mean number of units transfused per patient 5 days
Secondary Calculated Blood Loss Calculated blood loss 5 days
Secondary Number of Participants With Venous Thromboembolism (VTE) Diagnosis Incidence of symptomatic VTE diagnosed within 6 months of surgery Within 6 months of surgery
Secondary Number of Participants With Wound Complications Wound complications diagnosed within 6 months of surgery Within 6 months of surgery
Secondary Number of Participants With Myocardial Infarction (MI) Diagnosis MI diagnosed within 6 months of surgery Within 6 months of surgery
Secondary Number of Participants With Cerebrovascular Accident (CVA) Diagnosis CVA diagnosed within 6 months of surgery Within 6 months of surgery
Secondary Number of Participants Who Died All-cause mortality at 6 months 6 months after surgery
See also
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Active, not recruiting NCT00859378 - Cemented vs Non-cemented Semiendoprosthesis in the Treatment of Proximal Femoral Fractures N/A