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

NCT ID: NCT05874583

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-12-31

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.

Detailed Description

The investigators provided the pre-anaesthetic consultation. They carried out a rigorous clinical examination, a balancing of the defects and an adjustment of the therapies. The patients' written and informed consent was obtained. All patients had a preoperative blood count, blood grouping, renal assessment with dosage of uremia and creatinine. The investigators calculated the tolerable losses (mL). Randomization and allocation were carried out at this stage by an anesthesiologist other than the one managing the patient perioperatively.

On arrival in the operating room, the investigators set up the following systematic monitoring: electrocardioscope, pulse oximetry, gas analyzer, monitoring of capnia and curarization in the event of general anesthesia, non-invasive blood pressure. Two peripheral venous approaches were put in place. All patients received antibiotic prophylaxis with 2 g of Cefazolin and in case of allergy 900 mg of Dalacin. The anesthetic protocol was standardized. The choice between general or locoregional anesthesia was left to the discretion of the anesthesiologist treating the patient. For each patient, the investigators specified: The surgical approach, the type of prosthesis (cemented or not), the intraoperative posture, the duration of the procedure and of the anesthesia. During intraoperative monitoring, any hypotension with a decrease in mean arterial pressure of 20% of the baseline value for a period of more than 3 minutes or other complications were mentioned. The estimated bleeding (contents of the suction jar, number of drapes and compresses soaked in blood) with determination of the percentage of total losses intraoperatively as well as the results of the intraoperative blood count (if deemed necessary) were also specified. Transfusion of labile blood products was managed according to the patient's terrain, the degree of anemia, the speed of onset of the anemia and his hemodynamic tolerance. The analgesic protocol was also standardized.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Intravenous Group

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

Group Type: ACTIVE_COMPARATOR

Intravenous route Tranexamic acid injection

Intervention Type: DRUG

Intra venous route administration

Combined Group

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

Group Type: EXPERIMENTAL

Combined route administration of Tranexamic acid

Intervention Type: DRUG

tranexamic acid in topical route administration

Interventions

Combined route administration of Tranexamic acid

tranexamic acid in topical route administration

Intervention Type: DRUG

Intravenous route Tranexamic acid injection

Intra venous route administration

Intervention Type: DRUG

Other Intervention Names

Intravenous and topical administration; Intravenously only

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mongi Slim Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mhamed Sami Mebazaa

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mhamed Sami MS Mebazaa, Pr

Role: PRINCIPAL_INVESTIGATOR

Mongi Slim local research ethical committee

Locations

Mongi Slim University Hospital

La Marsa, Tunis Governorate, Tunisia

Countries

Tunisia

Other Identifiers

TXA in joint replacement

Identifier Type: -

Identifier Source: org_study_id