TXA-CRT: Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery

• Sponsor: Basque Health Service (Other)
• Overall Status: Completed
• CT.gov ID: NCT01199627
• Collaborator: (none)
• Enrollment: 114
• Location: 1
• Arms: 3
• Duration (Months): 23.1
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hip Replacement, Total	Drug: A; Drug: B; Drug: C	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• 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
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. blood loss (ml) [4 hours]

2. blood loss 8 hours (ml) [8 hours]

3. blood loss 24 hours (ml) [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Txagorritxu Hospital	Vitoria-Gasteiz	Alava	Spain	01009

Sponsors and Collaborators

• Basque Health Service

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01199627
• Other Study ID Numbers: TXA-CRT
• First Posted: Sep 13, 2010
• Last Update Posted: Feb 7, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by , ,: total hip replacement; tranexamic acid
• Additional relevant MeSH terms: Hemorrhage

Study Results

No Results Posted as of Feb 7, 2013