Clinical trial NCT01199627: Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery
Official title: Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery - Randomized, Controlled and Double-masked Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hip Replacement, Total
Keywords: total hip replacement
tranexamic acid
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2010-09-13
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 with other surgeries and CRT results have been positive, but the variety of dosages difficult to evaluate the results To determine the efficacy and safety of TXA in reducing bleeding caused by surgery of total hip replacement.

PATIENTS: Patients ASA(American Society of Anesthesiologists) I-III that they are to perform hip replacement surgery and cementless unilateral total that have signed the informed consent.

Group A: 1st dose 15mg/kg of TXA in 100ml saline 0.9% after the completion of regional anesthesia, and before the start of surgery.

2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration.

Group B: 1st dose: 10mg/kg of TXA in 100ml 0.9% saline after the completion of regional anesthesia, and before the start of surgery.

2nd dose: intravenous infusion over 10 minutes of 10mg/kg of TXA in 100ml saline 0.9% at three hours after the first administration.

Group C: 1st dose: intravenous infusion over 10 minutes in 100ml of 0.9% saline after the completion of regional anesthesia, and before the start of surgery.

2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration.

STATISTICAL ANALYSIS Comparison of blood loss in groups and comparison of adverse events


Eligibility criteria: Inclusion Criteria:

* 18 years or more
* ASA I-III
* No allergies tranexamic acid
* Informed consent signed by patient

Exclusion Criteria:

* 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.

Primary outcomes:
measure: blood loss (ml)
timeFrame: 4 hours
measure: blood loss 8 hours (ml)
timeFrame: 8 hours
measure: blood loss 24 hours (ml)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Txagorritxu Hospital
state: Alava
Study officials:
affiliation: Osakidetza-Basque Country Health Service
name: Borja Barrachina, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Osakidetza-Basque Country Health Service
name: Cesar Valero, MD
role: STUDY_CHAIR
affiliation: Osakidetza-Basque Country Health Service
name: Amanda Lopez, pharmacist
role: STUDY_CHAIR
References: