Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery (TXA-CRT)
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Hip Replacement, Total |
Drug: A Drug: B Drug: C |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention |
| Official Title: | Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery - Randomized, Controlled and Double-masked Trial |
- blood loss (ml) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- blood loss 8 hours (ml) [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
- blood loss 24 hours (ml) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| Enrollment: | 114 |
| Study Start Date: | March 2011 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Group A: 1st dose 15mg/kg of TXA (tranexamic acid) 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. |
Drug: A
Group A: 1st dose 15mg/kg of TXA (tranexamic acid) 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. |
|
Experimental: B
Group B: 1st dose: 10mg/kg of TXA (tranexamic acid) 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. |
Drug: B
Group B: 1st dose: 10mg/kg of TXA(tranexamic acid) 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. |
|
Placebo Comparator: C
Placebo
|
Drug: C
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. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Spain | |
| Txagorritxu Hospital | |
| Vitoria-Gasteiz, Alava, Spain, 01009 | |
| Principal Investigator: | Borja Barrachina, MD | Osakidetza-Basque Country Health Service |
| Study Chair: | Cesar Valero, MD | Osakidetza-Basque Country Health Service |
| Study Chair: | Amanda Lopez, pharmacist | Osakidetza-Basque Country Health Service |
More Information
No publications provided
| Responsible Party: | Francisco Borja Barrachina Larraza, Basque Health Service |
| ClinicalTrials.gov Identifier: | NCT01199627 History of Changes |
| Other Study ID Numbers: | TXA-CRT |
| Study First Received: | September 7, 2010 |
| Last Updated: | February 6, 2013 |
| Health Authority: | Spain: Spanish Agency of Medicines Spain: Ethics Committee |
Keywords provided by Basque Health Service:
|
total hip replacement tranexamic acid |
Additional relevant MeSH terms:
|
Tranexamic Acid Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Hemostatics Coagulants Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013