Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery

NCT01199627 | Completed Phase 3

• 1 other identifier: TXA-CRT
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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

Conditions

Hip Replacement, Total

Keywords

total hip replacement; tranexamic acid

Outcome Measures

Primary Outcomes (3)

• blood loss (ml)

  4 hours

• blood loss 8 hours (ml)

  8 hours

• blood loss 24 hours (ml)

  24 hours

Study Arms (3)

A

EXPERIMENTAL

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

B

EXPERIMENTAL

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

C

PLACEBO COMPARATOR

Placebo

Drug: C

Interventions

A DRUG

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.

A

B DRUG

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.

B

C DRUG

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.

C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Basque Health Service: lead

Study Sites (1)

Txagorritxu Hospital

Vitoria-Gasteiz, Alava, 01009, Spain

Location

Study Officials

• Borja Barrachina, MD

  Osakidetza-Basque Country Health Service

  PRINCIPAL INVESTIGATOR

• Cesar Valero, MD

  Osakidetza-Basque Country Health Service

  STUDY CHAIR

• Amanda Lopez, pharmacist

  Osakidetza-Basque Country Health Service

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 7, 2010
• First Posted: September 13, 2010
• Study Start: March 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 7, 2013

Record last verified: 2013-02

Locations

ES (1)