Blood LossPhase 4NCT04494126
Effect of Perioperative Tranexamic Acid on Blood Loss During Management of Maxillofacial Trauma
A Phase 4 study testing Tranexamic acid in people with Blood Loss, run by College of Medical Sciences Teaching Hospital. Nepal.
Trial summary
This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the subsequent postoperative sequelae. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Loss
- 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
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2021to 15 Dec 2021
- 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing ORIF under GA for Maxillofacial fractures
- Patients between with ages of 16-65
- No cardiac comorbidities (hypertension, congenital heart malformation)
- No known coagulopathy
- No regular prescription medication altering normal blood coagulation (NSAIDs, other anticoagulants)
- ASA I and II patients
Who cannot join
- Patients younger than 16 and older than 65
- Patients with known coagulopathy
- Patients with cardiac comorbidities
- Patients with a family history of bleeding disorders
- ASA III or higher
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Perioperative Tranexamic Acid on Blood Loss During Management of Maxillofacial Trauma: A Randomized Double Blind Clinical Trial
This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and edema are objectively rated and complications are noted.
Read the detailed description
This is a prospective, randomized, double-blind pilot study investigating whether intravenous tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the subsequent postoperative sequelae. Intraoperative bleeding is calculated from anaesthesia chart and recorded in ml. Postoperative ecchymosis and bleeding are recorded as dichotomous events (yes/no) and are subjectively rated by both patient and surgeon on postoperative days 1and 2. Any surgical or postoperative complications are noted. Scores are aggregated for statistical analysis.
- Conditions
- Blood Loss
- Being tested
- Tranexamic acid, Placebo
- Keywords
- Maxillofacial trauma; blood loss
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called Injection TXA 1 gram
Drug: Tranexamic Acid Injectable Solution the drug will be given to patients intravenously at a dose of 10mg/kg pre-operatively after induction on general anesthesia before incision.
PlaceboDrug
Also called Normal saline
Other: Placebo (normal saline 0.9%) An equivalent amount of normal saline (0.9%) will be given to the patient pre-operatively after induction of general anesthesia. The amount of saline given will correspond to the same amount of fluid which would have been given had the patient been in the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | Experimental: TXA Group One gram of intravenous tranexamic acid (TXA) in normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 6 hours later in the postoperative period. Receives: Drug: Tranexamic acid |
| Placebo | Placebo comparator | Placebo Comparator: Control Group Intravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 6 hours later in the postoperative period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
Measured and recorded from the anaesthesia patient chart
Measured: Surgical period
Secondary outcomes (1)
Postoperative bleeding event
postoperative bleeding and ecchymosis subjectively reported by patient and assessed by clinician, recorded as a dichotomous outcome.
Measured: upto 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start15 Aug 2021 (estimated)
- Primary completion15 Oct 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood LossStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, Parallel assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- College of Medical Sciences Teaching Hospital. Nepal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashutosh Kumar Singh, College of Medical Sciences Teaching Hospital. Nepal
- Investigators
- Rajesh Yadav, MD, Study director, College of Medical Sciences Teaching hospital, Bharatpur, Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494126
- Sponsor's protocol ID
- CMSNepal1
- Status last verified
- Aug 2021
- First submitted
- 28 Jul 2020
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be used for internal use only. Any patient identifier will be removed from the final master chart before statistical analysis.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Tranexamic Acid on Blood Loss During Management of Maxillofacial Trauma: A Randomized Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04494126
- Acronym / sponsor ID
- CMSNepal1
- Conditions
- Blood Loss
- Keywords
- Maxillofacial trauma; blood loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- College of Medical Sciences Teaching Hospital. NepalUniversity, hospital or other
- Study start
- 15 Aug 2021 (estimated)
- Primary completion
- 15 Oct 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 31 Jul 2020 (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.
This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and edema are objectively rated and complications are noted.
Detailed description
This is a prospective, randomized, double-blind pilot study investigating whether intravenous tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the subsequent postoperative sequelae. Intraoperative bleeding is calculated from anaesthesia chart and recorded in ml. Postoperative ecchymosis and bleeding are recorded as dichotomous events (yes/no) and are subjectively rated by both patient and surgeon on postoperative days 1and 2. Any surgical or postoperative complications are noted. Scores are aggregated for statistical analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic acidExperimental: TXA Group One gram of intravenous tranexamic acid (TXA) in normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 6 hours later in the postoperative period. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Comparator: Control Group Intravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 6 hours later in the postoperative period. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients undergoing ORIF under GA for Maxillofacial fractures
- Patients between with ages of 16-65
- No cardiac comorbidities (hypertension, congenital heart malformation)
- No known coagulopathy
- No regular prescription medication altering normal blood coagulation (NSAIDs, other anticoagulants)
Key exclusion criteria (5 listed)
- Patients younger than 16 and older than 65
- Patients with known coagulopathy
- Patients with cardiac comorbidities
- Patients with a family history of bleeding disorders
- ASA III or higher
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 acidAlso: Injection TXA 1 gramDrug: Tranexamic Acid Injectable Solution the drug will be given to patients intravenously at a dose of 10mg/kg pre-operatively after induction on general anesthesia before incision. | Drug | Tranexamic acid |
| PlaceboAlso: Normal salineOther: Placebo (normal saline 0.9%) An equivalent amount of normal saline (0.9%) will be given to the patient pre-operatively after induction of general anesthesia. The amount of saline given will correspond to the same amount of fluid which would have been given had the patient been in the intervention group. | Drug | Placebo |
Primary outcome
Intraoperative blood loss
Time frame: Surgical period
Measured and recorded from the anaesthesia patient chart
1 secondary outcome
Postoperative bleeding event
Time frame: upto 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: No. The data will be used for internal use only. Any patient identifier will be removed from the final master chart before statistical analysis.
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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.
Rajesh Yadav, MD study director
College of Medical Sciences Teaching hospital, Bharatpur, Nepal
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid in people with Blood Loss, run by College of Medical Sciences Teaching Hospital. Nepal.
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 6 inclusion and 5 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 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Ashutosh K Singh, MDS (+9779855082369, dr.ashutosh@cmsnepel.edu.np), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: Surgical period). 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 Aug 2021.