Clinical trial

Prevention of Bleeding in Total Joint Replacement: Contribution of Combined Route in Tranexamic Acid Administration

Name

TXA in joint replacement

Description

The investigators aimed to compare two doses of intravenous (IV) tranexamic acid (TXA) with a combined single dose of topical and IV TXA on haemoglobin decline 24 hours after total joint arthroplasties. The investigators conducted randomized, double-blind trial. The participants were randomized to either intrvenous group receiving 2 doses of 1 gram TXA in intravenous route 3 hours apart, or a combined application group receiving the first 1 gram IV and the topical dose was 1.5 gram after reduction of the fascia.

Trial arms

Trial start

2021-12-01

Estimated PCD

2022-09-30

Trial end

2022-12-31

Status

Completed

Treatment

Combined route administration of Tranexamic acid

tranexamic acid in topical route administration

Arms:

Combined Group

Other names:

Intravenous and topical administration

Intravenous route Tranexamic acid injection

Intra venous route administration

Arms:

Intravenous Group

Other names:

Intravenously only

Size

100

Primary endpoint

Haemoglobin decline

up to 24 hours after surgery

Eligibility criteria

Inclusion Criteria: * Patients aged of 18 years or more; * Primary total hip or knee arthroplasty; * A traumatic, degenerative or malformative setting. Exclusion Criteria: * Revisions; * Bilateral procedures; * Polytrauma; * Pregnant patients; * Contraindications for the use of TXA, Coagulation disorders or anaemia with Haemoglobin (Hb) less than or equal to 9 g/dl preoperatively; * Patients treated with anticoagulants, Heparin, Warfarin, Oestrogen. * Serious anaesthesia-related complications (impossible orotracheal intubation , anaphylactic shock); * Severe transfusion reaction such as haemolysis.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

Updated at

2023-05-25

1 organization

1 product

6 indications

Organization

Mongi Slim Hospital

Product

Tranexamic acid

Indication

Tranexamic Acid

Indication