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

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

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.

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Knee; Blood Transfusion; Arthroplasty, Replacement, Hip; Tranexamic Acid
• Intervention / Treatment: Drug: Intravenous route Tranexamic acid injection; Drug: Combined route administration of Tranexamic acid

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Tunis
    • La Marsa, Tunis, Tunisia, 2046
      • Mongi Slim University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravenous Group; patients receiving 2 doses of 1 g of tranexamic acid in in intra venous route 3 hours apart	Drug: Intravenous route Tranexamic acid injection; Intra venous route administration; Other Names: Intravenously only
Experimental: Combined Group; 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; tranexamic acid in topical route administration; Other Names: Intravenous and topical administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemoglobin decline	The decline of hemoglobin levels	up to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The use of blood transfusion	Number of transfusion needed	up to 24 hours after surgery.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thromboembolic complications	postoperative deep vein thrombosis or pulmonary embolism	Up to 3 months after surgery

Collaborators and Investigators

• Sponsor: Mongi Slim Hospital
• Investigators: Principal Investigator: Mhamed Sami MS Mebazaa, Pr, Mongi Slim local research ethical committee

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: TXA in joint replacement

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No