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

NCT05874583 | Completed

• 1 other identifier: TXA in joint replacement
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tranexamic Acid; Arthroplasty, Replacement, Knee; Blood Transfusion; Arthroplasty, Replacement, Hip

Outcome Measures

Primary Outcomes (1)

• Haemoglobin decline

  The decline of hemoglobin levels

  up to 24 hours after surgery

Secondary Outcomes (1)

• The use of blood transfusion

  up to 24 hours after surgery.

Other Outcomes (1)

• Thromboembolic complications

  Up to 3 months after surgery

Study Arms (2)

Intravenous Group

ACTIVE COMPARATOR

patients receiving 2 doses of 1 g of tranexamic acid in in intra venous route 3 hours apart

Drug: Intravenous route Tranexamic acid injection

Combined Group

EXPERIMENTAL

receiving the first 1g of tranexamic acid Intra venously and the second topical dose was 1,5g after reduction of the fascia.

Drug: Combined route administration of Tranexamic acid

Interventions

Combined route administration of Tranexamic acid DRUG

tranexamic acid in topical route administration

Also known as: Intravenous and topical administration

Combined Group

Intravenous route Tranexamic acid injection DRUG

Intra venous route administration

Also known as: Intravenously only

Intravenous Group

Eligibility Criteria

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

You may qualify if:

• Patients aged of 18 years or more;
• Primary total hip or knee arthroplasty;
• A traumatic, degenerative or malformative setting.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mongi Slim Hospital: lead

Study Sites (1)

Mongi Slim University Hospital

La Marsa, Tunis Governorate, 2046, Tunisia

Location

MeSH Terms

Interventions

Administration, Topical

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mhamed Sami MS Mebazaa, Pr

  Mongi Slim local research ethical committee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 25, 2023
• Study Start: December 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

TU (1)