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

Primary Purpose

Tranexamic Acid, Arthroplasty, Replacement, Knee, Blood Transfusion

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Combined route administration of Tranexamic acid
Intravenous route Tranexamic acid injection
Sponsored by
Mongi Slim Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tranexamic Acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mongi Slim University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intravenous Group

Combined Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Haemoglobin decline
The decline of hemoglobin levels

Secondary Outcome Measures

The use of blood transfusion
Number of transfusion needed

Full Information

First Posted
April 26, 2023
Last Updated
May 15, 2023
Sponsor
Mongi Slim Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05874583
Brief Title
Prevention of Bleeding in Total Joint Replacement: Combined Route Administration of Tranexamic Acid
Official Title
Prevention of Bleeding in Total Joint Replacement: Contribution of Combined Route in Tranexamic Acid Administration
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mongi Slim Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tranexamic Acid, Arthroplasty, Replacement, Knee, Blood Transfusion, Arthroplasty, Replacement, Hip

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous Group
Arm Type
Active Comparator
Arm Description
patients receiving 2 doses of 1 g of tranexamic acid in in intra venous route 3 hours apart
Arm Title
Combined Group
Arm Type
Experimental
Arm Description
receiving the first 1g of tranexamic acid Intra venously and the second topical dose was 1,5g after reduction of the fascia.
Intervention Type
Drug
Intervention Name(s)
Combined route administration of Tranexamic acid
Other Intervention Name(s)
Intravenous and topical administration
Intervention Description
tranexamic acid in topical route administration
Intervention Type
Drug
Intervention Name(s)
Intravenous route Tranexamic acid injection
Other Intervention Name(s)
Intravenously only
Intervention Description
Intra venous route administration
Primary Outcome Measure Information:
Title
Haemoglobin decline
Description
The decline of hemoglobin levels
Time Frame
up to 24 hours after surgery
Secondary Outcome Measure Information:
Title
The use of blood transfusion
Description
Number of transfusion needed
Time Frame
up to 24 hours after surgery.
Other Pre-specified Outcome Measures:
Title
Thromboembolic complications
Description
postoperative deep vein thrombosis or pulmonary embolism
Time Frame
Up to 3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mhamed Sami MS Mebazaa, Pr
Organizational Affiliation
Mongi Slim local research ethical committee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mongi Slim University Hospital
City
La Marsa
State/Province
Tunis
ZIP/Postal Code
2046
Country
Tunisia

12. IPD Sharing Statement

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

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