Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202110492542153 Date of Approval: 20/10/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Tranexamic acid dosage regimens on blood loss in Hemi-Mandibulectomy
Official scientific title The effect of different dosage regimens of Tranexamic acid on blood loss in Hemi-Mandibulectomy: A randomized double blind study
Brief summary describing the background and objectives of the trial BACKGROUND Intra-operative bleeding during mandibular resection can be significant due to numerous microvasculature of the orofacial region, extensive dissections, increase fibrinolysis during surgery as well as inability to cauterize bleeding bone surfaces. This bleeding poses a great threat to the patient and can lead to severe consequences if uncontrolled. The oral and maxillofacial surgeon must be familiar with the strategies and haemostatic agents available for blood loss management. Unfortunately, some of the best preventive measures are not utilized because of lack of knowledge of the haemostatic mechanisms, the haemostatic agents and the approach to utilizing them. Tranexamic acid (TXA), a haemostatic agent; is an antifibrinolytic agent that act by competitively inhibiting the activation of plasminogen to fibrin, stabilizes formed clot and reduces active bleeding. It has been used successfully in many surgical specialties to reduce perioperative bleeding. Several studies have reported favourable efficacy and safety in many surgical fields, with no universal standard of administration and dosing. OBJECTIVES The aim of this study was to compare the effects of two dosage regimens of a single preoperative dose of tranexamic acid (10mg/kg vs 20mg/kg body weight) and 0.5% normal saline on blood loss during hemi-mandibulectomy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/01/2019
Actual trial start date 02/01/2019
Anticipated date of last follow up 31/03/2021
Actual Last follow-up date 31/03/2021
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 48
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TRANEXAMIC ACID A 20mg/kg body weight weight of Tranexamic acid(TXA) 30 minutes prior to induction of Anaesthesia for surgery 20mg/kg TXA injected into 100mls of Saline given over 30minutes prior to induction of Anesthesia. 16
Experimental Group TRANEXAMIC ACID B 10mg/kg body weight of Tranexamic acid 30 minutes prior to induction of Anaesthesia for surgery 10mg/kg TXA injected into 100mls of Saline given over 30minutes prior to induction of Anesthesia. 16
Control Group NORMAL SALINE 100mls of 0.9% Normal Saline 30 minutes prior to induction of Anaesthesia for surgery 100mls of 0.9% Normal Saline given over 30minutes prior to induction of Anesthesia. 16 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Willing and consenting patients aged 18-64years, 2. Healthy and physical status I and II according to the American Society of Anaesthesiologists (ASA) physical status classification 1. Patients who refused to participate 2. Patients with known allergy to tranexamic acid 3. Patients with history or risk of thromboembolism (including patients on oral contraceptive pills, and anticoagulants)’ 4. Patients with uncontrolled hypertension, renal or hepatic dysfunction and coagulopathy, 5. Patients with likelihood of difficult intubation (Mallampati III and IV) were excluded from the study 6. Patients with haematological diseases or any form of bleeding diathesis following the review of the clotting profile including platelet count less than 150000/m3 7. Patients with a history of convulsion Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/04/2019 Ethics and Research Committee University of Benin Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Ugbowo Benin City 1111 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Amount of Blood loss in millilitres From knife on Skin to time of placement of the last sutures
Secondary Outcome Units of Blood transfused in pints From knife on Skin to time of placement of the last sutures
Secondary Outcome Duration of operation in minutes From knife on Skin to time of placement of the last sutures
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Benin Teaching Hospital Ugbowo Benin City Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Okoro Ndidi Ugbowo Benin City Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Okoro Ndidi Department of Oral and Maxillofacial Surgery, University of Benin teaching Hospital, Ugbowo Benin City Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ndidi Okoro drokorondidi@gmail.com +2348036019521 Department of Oral and Maxillofacial Surgery, University of Benin Teaching Hospital, Ugbowo
City Postal code Country Position/Affiliation
Benin City Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Ndidi Okoro drokorondidi@gmail.com +2348036019521 Department of Oral and Maxillofacial Surgery, University of Benin Teaching Hospital, Ugbowo
City Postal code Country Position/Affiliation
Benin City Nigeria Senior registrar
Role Name Email Phone Street address
Scientific Enquiries Ndidi Okoro drokorondidi@gmail.com +2348036019521 Department of Oral and Maxillofacial Surgery, University of Benin Teaching Hospital, Ugbowo
City Postal code Country Position/Affiliation
Benin City Nigeria Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be shared excluding their personal identification information Informed Consent Form,Statistical Analysis Plan,Study Protocol within 2 years of study completion Controlled access , all data will be shared excluding the personal identification information, permission can be given by third party to qualified researchers in the field of Oral and Maxillofacial surgery, Public health and other related professionals.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information