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

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05874583
• Other study ID #: TXA in joint replacement
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: Mongi Slim Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Arthroplasty, Replacement, Knee
• Blood Transfusion
• Hemorrhage
• Tranexamic Acid

Intervention

Drug:
• Combined route administration of Tranexamic acid
tranexamic acid in topical route administration
• Intravenous route Tranexamic acid injection
Intra venous route administration

Locations

Country	Name	City	State
Tunisia	Mongi Slim University Hospital	La Marsa	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Mongi Slim Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Thromboembolic complications	postoperative deep vein thrombosis or pulmonary embolism	Up to 3 months after surgery
Primary	Haemoglobin decline	The decline of hemoglobin levels	up to 24 hours after surgery
Secondary	The use of blood transfusion	Number of transfusion needed	up to 24 hours after surgery.