To Calculate Total Blood Loss Immediately PostoperativePhase 4NCT06188052
Efficacy of Topical Versus Intravenous Tranexamic Acid in Controlling Blood Loss
A Phase 4 study testing Tranexamic acid in people with To Calculate Total Blood Loss Immediately Postoperative, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Total laryngectomy with bilateral block neck dissection is considered one of the major head and neck surgeries. Intraoperative bleeding is considered a risk factor for this operation specially that the population of this operation are elder with multiple comorbidities. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- To Calculate Total Blood Loss Immediately Postoperative
- What is being tested?
- Tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 31 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either sex, aged between 18-70 years old, ASA physical status I, II undergoing total laryngectomy
Who cannot join
- Patients with coagulopathy, a history of thromboembolism or a history of tranexamic acid allergy or complication will be excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University hospitals
Cairo, 11559
Dina M Mohamed, MD, 01005249134 ext. MD, Dinamahmoud@kasralainy.edu.eg
About this study
Official title: Efficacy of Topical Versus Intravenous Tranexamic Acid in Controlling Blood Loss in Patients Undergoing:Total Laryngectomy With Neck Dissection. A Randomized Control Study.
Total laryngectomy with bilateral block neck dissection is considered one of the major head and neck surgeries. Intraoperative bleeding is considered a risk factor for this operation specially that the population of this operation are elder with multiple comorbidities. Intravenous administration of tranexamic acid reduces bleeding during surgery.We design this study aiming to prove the role of topical tranexamic acid in controlling the intraoperative bleeding in patients undergoing total laryngectomy operation avoiding the risk of intravenous administration.
Read the detailed description
45 patients undergoing total laryngectomy operation will be enrolled in this study. The patients will be divided into 3 equal groups, 15 patients in each group. Group (A), tranexamic acid will be given 1 hr preoperatively. Group (B), topical tranexamic acid will be given as an irrigation to the surgical site. Group (C), control group.One hour preoperatively, a wide bore cannula will be inserted to all patients. Tranexamic acid 1mg/kg will be given intravenously to patients in group (A). Normal saline will be given to Group (B) and group (C) .On arrival to the operating room, a pulse oximetry, continuous electrocardiogram (ECG), and non-invasive blood pressure measurement device will be connected to the patient. Pre-medications will be given; metoclopramide (10mg) and dexamethasone (8mg) preoperatively. Induction will be done by sevoflurane, propofol 1mg/ kg, succinyl choline 0.5mg/kg. After intubation, fentanyl 2mic/kg and atracurium 0.5mg/kg will be given , followed by 0.8 mg/kg Morphine sulphate . Anesthesia will be maintained by isoflurane 1.5% and atracurium 0.1mg/kg/ 30min. After flap elevation ( using local infiltraton of epinephrine 1/100000), the surgical site will be irrigated by 40 ml of tranexamic acid 2mg/kg dissolved in 200ml normal saline every 1 hour for the first 5 hours in group (B), and by normal saline in group (A) and group (C).
- Being tested
- Tranexamic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Comparing the 3 groups regarding intraoperative bleeding, hemoglobin level pre and postoperative and the need of blood transfusion
| Study group | Role | What they receive |
|---|---|---|
| Group (A), tranexamic acid IV | Active comparator | tranexamic acid will be given 1 hr preoperatively as 1mg/kg intravenously Receives: Drug: Tranexamic acid |
| Group (B), topical tranexamic acid | Active comparator | topical tranexamic acid will be given as an irrigation by 40 ml of tranexamic acid 2mg/kg dissolved in 200ml to the surgical site every 1 hour for the first 5 hours . Receives: Drug: Tranexamic acid |
| Group (C), control group. | Placebo comparator | Saline will be given intravenously instead of tranexamic acid And irrigation with Saline instead of tranexamic acid Receives: Drug: Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
To calculate total blood loss immediately postoperative and compare it in 3 groups To calculate total blood loss and compare 3 groups
Intraoperative bleeding will be assessed and blood loss will be measured in ml ( amount of blood in canister and sponges)
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Aug 2023
- Primary completion10 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Calculate Total Blood Loss Immediately PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mahmoud Mohamed, Kasr El Aini Hospital
- Investigators
- Dina M Mohamed, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188052
- Sponsor's protocol ID
- MS-97-2023
- Status last verified
- Jan 2024
- First submitted
- 19 Sep 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Versus Intravenous Tranexamic Acid in Controlling Blood Loss in Patients Undergoing:Total Laryngectomy With Neck Dissection. A Randomized Control Study.
- ClinicalTrials.gov ID
- NCT06188052
- Acronym / sponsor ID
- MS-97-2023
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 10 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total laryngectomy with bilateral block neck dissection is considered one of the major head and neck surgeries. Intraoperative bleeding is considered a risk factor for this operation specially that the population of this operation are elder with multiple comorbidities. Intravenous administration of tranexamic acid reduces bleeding during surgery.We design this study aiming to prove the role of topical tranexamic acid in controlling the intraoperative bleeding in patients undergoing total laryngectomy operation avoiding the risk of intravenous administration.
Detailed description
45 patients undergoing total laryngectomy operation will be enrolled in this study. The patients will be divided into 3 equal groups, 15 patients in each group. Group (A), tranexamic acid will be given 1 hr preoperatively. Group (B), topical tranexamic acid will be given as an irrigation to the surgical site. Group (C), control group.One hour preoperatively, a wide bore cannula will be inserted to all patients. Tranexamic acid 1mg/kg will be given intravenously to patients in group (A). Normal saline will be given to Group (B) and group (C) .On arrival to the operating room, a pulse oximetry, continuous electrocardiogram (ECG), and non-invasive blood pressure measurement device will be connected to the patient. Pre-medications will be given; metoclopramide (10mg) and dexamethasone (8mg) preoperatively. Induction will be done by sevoflurane, propofol 1mg/ kg, succinyl choline 0.5mg/kg. After intubation, fentanyl 2mic/kg and atracurium 0.5mg/kg will be given , followed by 0.8 mg/kg Morphine sulphate . Anesthesia will be maintained by isoflurane 1.5% and atracurium 0.1mg/kg/ 30min. After flap elevation ( using local infiltraton of epinephrine 1/100000), the surgical site will be irrigated by 40 ml of tranexamic acid 2mg/kg dissolved in 200ml normal saline every 1 hour for the first 5 hours in group (B), and by normal saline in group (A) and group (C).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (A), tranexamic acid IV | Active comparator | Drug: Tranexamic acidtranexamic acid will be given 1 hr preoperatively as 1mg/kg intravenously |
| Group (B), topical tranexamic acid | Active comparator | Drug: Tranexamic acidtopical tranexamic acid will be given as an irrigation by 40 ml of tranexamic acid 2mg/kg dissolved in 200ml to the surgical site every 1 hour for the first 5 hours . |
| Group (C), control group. | Placebo comparator | Drug: Tranexamic acidSaline will be given intravenously instead of tranexamic acid And irrigation with Saline instead of tranexamic acid |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of either sex, aged between 18-70 years old, ASA physical status I, II undergoing total laryngectomy
Key exclusion criteria (1 listed)
- Patients with coagulopathy, a history of thromboembolism or a history of tranexamic acid allergy or complication will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidComparing the 3 groups regarding intraoperative bleeding, hemoglobin level pre and postoperative and the need of blood transfusion | Drug | Group (A), tranexamic acid IV, Group (B), topical tranexamic acid, Group (C), control group. |
Primary outcome
To calculate total blood loss immediately postoperative and compare it in 3 groups To calculate total blood loss and compare 3 groups
Time frame: Intraoperative
Intraoperative bleeding will be assessed and blood loss will be measured in ml ( amount of blood in canister and sponges)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dina M Mohamed, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid in people with To Calculate Total Blood Loss Immediately Postoperative, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina M Mohamed, Lecturer (01005249134 ext. MD, Dinamahmoud@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To calculate total blood loss immediately postoperative and compare it in 3 groups To calculate total blood loss and compare 3 groups (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.