Anemia Clinical Trial
Official title:
Effect of Tranexamic Acid on Blood Loss and Transfusion Need in Patients Operated With a Short Intramedullary Nail, for Pertrochanteric Fractures .
Verified date | February 2015 |
Source | Hvidovre University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Dataprotection Agency |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 72 |
Est. completion date | August 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Hvidovre Hospital | Hvidovre | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Yes |
Secondary | Transfusions | Information from local blood bank | From admission to third day after surgery. | No |
Secondary | Mortality | Mortality is obtained via central personal registration system (Danish CPR system) | 30 days and 90 days follow up | No |
Secondary | 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 | Yes |
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