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Completed

NCT Number: NCT05874583

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mongi Slim University Hospital

La Marsa, Tunis Governorate, 2046, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combined route administration of Tranexamic acid

Drug

tranexamic acid in topical route administration

Other names: Intravenous and topical administration

Intravenous route Tranexamic acid injection

Drug

Intra venous route administration

Other names: Intravenously only

Primary outcomes

  1. Haemoglobin decline

    Time frame: up to 24 hours after surgery

    The decline of hemoglobin levels

Secondary outcomes

  1. The use of blood transfusion

    Time frame: up to 24 hours after surgery.

    Number of transfusion needed

Other outcomes

  1. Thromboembolic complications

    Time frame: Up to 3 months after surgery

    postoperative deep vein thrombosis or pulmonary embolism

Sponsors and collaborators

Lead sponsor

Mongi Slim Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 25, 2023
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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