Status:
COMPLETED
Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery
Lead Sponsor:
Basque Health Service
Conditions:
Hip Replacement, Total
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The bleeding caused by hip replacement surgery (CRT) is an important source of demand for blood in the hospital. Tranexamic acid (TXA) is a drug that has proved useful in reducing bleeding associated ...
Eligibility Criteria
Inclusion
- 18 years or more
- ASA I-III
- No allergies tranexamic acid
- Informed consent signed by patient
Exclusion
- Pregnancy or lactation.
- severe vascular ischemia (coronary or peripheral)
- previous venous thrombosis, pulmonary embolism or embolic disease (atrial fibrillation, active neoplastic disease)
- coagulopathy
- Chronic treatment with ASA(acetylsalicylic acid) or NSAIDs (nonsteroidal anti-inflammatory drugs) prior to surgery without suspension
- Hemoglobine \<10
- moderate renal impairment (creatinine\> 2)
- Cirrhosis
- contraindication to prophylaxis with enoxaparin
- Patients with a history of seizures.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT01199627
Start Date
March 1 2011
End Date
February 1 2013
Last Update
February 7 2013
Active Locations (1)
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1
Txagorritxu Hospital
Vitoria-Gasteiz, Alava, Spain, 01009