MedDataX Logo

Efficacy Comparison of Topical and Intravenous Tranexamic Acid to Reduce the Number of Blood Transfusions in TKA

NCT ID: NCT01881568

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main objective is to evaluate the efficacy and safety of topical Tranexamic Acid (TA) to reduce the blood transfusion rate in total knee arthroplasty. The secondary endpoints are to estimate the visible blood loss at 24 hours after surgery, and invisible blood loss through serial counting of Hb/Htc. Methodology. TRANEX1 is a phase III, unicentric, controlled, randomized, double blind clinical trial that compare efficacy and safety of topical TA versus intravenous TA in a multimodal protocol, with no-inferiority criteria(n=79).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The groups will be compared by ITT and PP. The non-inferiority would be estimated by comparing the confidence interval using the traditional test, and Wilson test.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

1. Topical administration of 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride) as follow:

* 50mL by irrigation before wound closure
* 50mL by intraarticular administration (Drenofast) after wound closure.
2. Intravenous administration of Normal saline (0.9% sodium chloride) as follow:

* 100mL before tourniquet realised
* 100mL 3 hours after surgery

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

Topical administration: 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride)

Comparator

1. Topical administration of Normal saline (0.9% sodium chloride) as follow:

* 50mL by irrigation before wound closure
* 50mL by intraarticular administration (Drenofast) after wound closure
2. Intravenous administration of two dosis of Tranexamic Acid as follow:

* 15mg/kg of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride), before tourniquet realised
* 15mg/kg of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride), 3 hours after surgery

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

Intravenous administration of two dosis of Tranexamic Acid (15mg/kg of Tranexamic Acid in 100mL of normal saline each)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tranexamic Acid

Topical administration: 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride)

Intervention Type DRUG

Tranexamic Acid

Intravenous administration of two dosis of Tranexamic Acid (15mg/kg of Tranexamic Acid in 100mL of normal saline each)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AMCHAFIBRIN AMCHAFIBRIN,

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patients (greater than 18 years old)
* Patients scheduled for primary unilateral knee arthroplasty
* Patients for La Paz- Cantoblanco Hospital, Madrid, Spain

Exclusion Criteria

* Patients that refuse to sign the Inform Consent
* Allergy to tranexamic acid
* Major comorbidities: Severe ischemic heart disease(class III and IV of New York Heart Association); sleep apnea syndrome; severe EPOC; renal dysfunction (plasma creatinine\>2mg/dL if mens and \>1.8mg/dL if woman); or hepatic disfunction.
* Coagulopathy (preoperative platelet count \<150,000/mm3, INR\>1.4, prolonged PPT(\>1.4 x normal)
* History of thromboembolic disease: CVA, DVT, PE
* Blood dyscrasias
* Retinopathy (disturbances of color vision)
* Jehovah's witnesses
* Pregnancy
* Breastfeeding
* Been participating or been participated a year ago in another clinical trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Universitario La Paz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Enrique Gómez Barrena

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Enrique Gomez Barrena, PI

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universitario La Paz

Madrid, Madrid, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Perez-Chrzanowska H, Figueredo-Zalve R. Topical intra-articular compared with intravenous tranexamic acid to reduce blood loss in primary total knee replacement: a double-blind, randomized, controlled, noninferiority clinical trial. J Bone Joint Surg Am. 2014 Dec 3;96(23):1937-44. doi: 10.2106/JBJS.N.00060.

Reference Type DERIVED
PMID: 25471907 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TRANEX1

Identifier Type: -

Identifier Source: org_study_id