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Hemoglobin Level MeasurementPhase 2NCT07392034

Efficacy of Tranexamic Acid Reducing Blood Loss During Maxillofacial Trauma Surgery

A Phase 2 study testing Tranexamic Acid (TXA) and Normal saline in people with Hemoglobin Level Measurement and Blood Loss During Surgery, run by Nishtar Medical University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Tranexamic acid (TXA) is an inexpensive, easily used and relatively safe drug. It inhibits plasminogen activation and plasmin thus retards clot disintegration.Therapeutic application of tranexamic acid in trauma for preventing blood loss has been documented since long. Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
What is being tested?
Tranexamic Acid (TXA) and Normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 sitePakistan
Study dates
1 Jan 2025to 30 Jun 2025
Phase
Phase 2
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 20 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • either gender.
  • presenting within seven days of trauma.
  • planned for maxillofacial surgery.

Who cannot join

  • Patients with international normalized ratio (INR) greater than 1.5.
  • American Society of Anesthesiologists (ASA) physical status of 3 or higher.
  • chronic kidney disease.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Nishtar institute of dentistry, Multan

    Multan, Punjab Province, 66000

Other trials in Pakistan

About this study

Tranexamic acid (TXA) is an inexpensive, easily used and relatively safe drug. It inhibits plasminogen activation and plasmin thus retards clot disintegration.Therapeutic application of tranexamic acid in trauma for preventing blood loss has been documented since long. Since blood loss causes several serious complications, it is compensated emergently by transfusion of blood or its products. However, transfusion of blood and products always carries a risk of inadvertent transmission of infection, antigen-antibody reactions and additional cost all of which can be prevented if blood loss is reduced. Morbidity associated with the delay in compensating the blood loss could also be prevented by pharmaceutically preventing hemorrhage.

Read the detailed description

During management of maxillofacial injuries, hemostasis is essential to clear the airway also. It is reported that blood loss is the most common complication following maxillofacial fractures and their treatment.TXA oral rinse has been used for preventing excessive hemorrhage for patients with coagulopathies. IV TXA has also been proven to be effective in reducing bleeding in healthy adults undergoing third molar surgery. Administration of TXA has also been evaluated and found effective in reducing post-surgical hemorrhage during and after bimaxillary orthognathic surgery.

This study has been planned to evaluate how efficacious is preoperative tranexamic acid in decreasing blood loss while performing surgery in cases with maxillofacial trauma in our local setting. the study results will provide local evidence and will support the incorporation of safe and inexpensive drug i.e., TXA into trauma clinical practice guidelines and local treatment protocols.

Being tested
Tranexamic Acid (TXA), Normal saline
Keywords
Tranexamic acid, Oral and maxillofacial trauma surgery, Blood loss, Hemoglobin, Duration of surgery
Medical subject headings
Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic Acid (TXA)Drug

    Thirty minutes prior to surgery, the intervention group receive intravenous , single dose of tranexamic acid of 20 mg/kg.

  • Normal salineDrug

    Thirty minutes prior to surgery, the placebo group received single dose of 20 mL of normal saline.

Study groups in NCT07392034
Study groupRoleWhat they receive
Trenexamic acid groupActive comparatorThirty minutes prior to surgery, the intervention group received intravenous trenexamic acid at a dose of 20 mg/kg.
Receives: Drug: Tranexamic Acid (TXA)
Placebo groupPlacebo comparatorThirty minutes prior to surgery, the placebo group received 20 mL of normal saline.
Receives: Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mean intraoperative blood loss

    mean intraoperative blood loss between patients receiving intravenous tranexamic acid and those receiving placebo during maxillofacial trauma surgery.

    Measured: Immediately at the end of surgery

Secondary outcomes (2)

  1. mean drop in hemoglobin levels postoperatively

    To assess the mean drop in hemoglobin levels postoperatively between the TXA and placebo groups.

    Measured: 03 hours after post operatively

  2. intraoperative blood transfusion

    To evaluate the need for intraoperative blood transfusion between the two groups.

    Measured: Preoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2026
  2. Study start1 Jan 2025
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07392034
Sponsor's protocol ID
12076/NID
Status last verified
Feb 2026
First submitted
19 Jan 2026
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Wong J, George RB, Hanley CM, Saliba C, Yee DA, Jerath A. Tranexamic acid: current use in obstetrics, major orthopedic, and trauma surgery. Can J Anaesth. 2021 Jun;68(6):894-917. doi: 10.1007/s12630-021-01967-7. Epub 2021 May 15.

    PubMed 33993459

  • Ramirez RJ, Spinella PC, Bochicchio GV. Tranexamic Acid Update in Trauma. Crit Care Clin. 2017 Jan;33(1):85-99. doi: 10.1016/j.ccc.2016.08.004.

    PubMed 27894501

  • Patel PA, Wyrobek JA, Butwick AJ, Pivalizza EG, Hare GMT, Mazer CD, Goobie SM. Update on Applications and Limitations of Perioperative Tranexamic Acid. Anesth Analg. 2022 Sep 1;135(3):460-473. doi: 10.1213/ANE.0000000000006039. Epub 2022 Aug 17.

    PubMed 35977357

  • PATCH-Trauma Investigators and the ANZICS Clinical Trials Group; Gruen RL, Mitra B, Bernard SA, McArthur CJ, Burns B, Gantner DC, Maegele M, Cameron PA, Dicker B, Forbes AB, Hurford S, Martin CA, Mazur SM, Medcalf RL, Murray LJ, Myles PS, Ng SJ, Pitt V, Rashford S, Reade MC, Swain AH, Trapani T, Young PJ. Prehospital Tranexamic Acid for Severe Trauma. N Engl J Med. 2023 Jul 13;389(2):127-136. doi: 10.1056/NEJMoa2215457. Epub 2023 Jun 14.

    PubMed 37314244

  • Colomina MJ, Contreras L, Guilabert P, Koo M, M Ndez E, Sabate A. Clinical use of tranexamic acid: evidences and controversies. Braz J Anesthesiol. 2022 Nov-Dec;72(6):795-812. doi: 10.1016/j.bjane.2021.08.022. Epub 2021 Oct 7.

    PubMed 34626756

  • Wu B, Lv K. Effect of tranexamic acid on postoperative blood loss. Br J Oral Maxillofac Surg. 2024 Jun;62(5):489-492. doi: 10.1016/j.bjoms.2024.04.002. Epub 2024 Apr 9.

    PubMed 38735769

  • Ockerman A, Vanassche T, Garip M, Vandenbriele C, Engelen MM, Martens J, Politis C, Jacobs R, Verhamme P. Tranexamic acid for the prevention and treatment of bleeding in surgery, trauma and bleeding disorders: a narrative review. Thromb J. 2021 Aug 11;19(1):54. doi: 10.1186/s12959-021-00303-9.

    PubMed 34380507

  • Khiabani K, Ahmadfar M, Labafchi A, Gosheh MR, Samieirad S. Is Preoperative Administration of Tranexamic Acid Effective on Blood Loss Reduction in Mandibular Fracture Surgeries? A Triple-Blind Randomized Clinical Trial. J Oral Maxillofac Surg. 2021 Feb;79(2):429.e1-429.e7. doi: 10.1016/j.joms.2020.09.011. Epub 2020 Sep 11.

    PubMed 33035492

  • Dunphy L, Williams R. Immune thrombocytopenic purpura presenting with spontaneous gingival haemorrhage in pregnancy. BMJ Case Rep. 2019 Jan 17;12(1):e228309. doi: 10.1136/bcr-2018-228309.

    PubMed 30659003

  • Chen MWJ, Yong CW, Lum JL. Use of an improvised clamp to manage bleeding tongue injuries. Am J Emerg Med. 2021 Jan;39:252.e1-252.e2. doi: 10.1016/j.ajem.2020.06.051. Epub 2020 Jun 25.

    PubMed 33008704

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tranexamic Acid (TXA) and Normal saline in people with Hemoglobin Level Measurement and Blood Loss During Surgery, run by Nishtar Medical University at 1 site in Pakistan.

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 3 inclusion and 3 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: finished, as of the sponsor's last update on 6 Feb 2026. 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 Pakistan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mean intraoperative blood loss (time frame: Immediately at the end of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07392034, which also lists 10 linked publications.

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 6 Feb 2026.

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