An Early Phase 1 interventional study of Tranexamic Acid (TXA) and Tranexamic Acid in Blood Loss, Surgical, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Assiut University · Early Phase 1, Interventional, and Health services research
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Among 46 studies testing Tranexamic Acid in Blood Loss, Surgical — 9 open to participants now, 9 under way, 4 of them phase 3. Tranexamic Acid · Blood Loss, Surgical.
Among the 46 studies testing Tranexamic Acid in Blood Loss, Surgical, this one is the 26th largest by planned enrollment, is one of 4 that started in 2025, is one of 6 in phase 1, and was the 39th registered.
213 studies on the registry are indexed under Blood Loss, Surgical; 40 are open to participants now.
Browse Blood Loss, Surgical studies →9 of the 46 studies testing Tranexamic Acid in Blood Loss, Surgical are open now, in 6 countries. Recruiting first, the newest first:
The University of Texas Health Science Center at San Antonio · Sites in United States
Ages 2–17
Wolfson Medical Center · Sites in Israel
Ages 18–51 · Women only · Healthy volunteers
The University of Texas Health Science Center at San Antonio · Sites in United States
Ages 2–17
University of Virginia · Sites in United States
Ages 18+ · Women only
Maasstad Hospital · Sites in Netherlands
Ages 18+
By country, each count listing its studies:
Tranexamic Acid: first FDA approval 1986 (CYKLOKAPRON). What it is approved for, and how studies give it, is on its page →
Of the 27 Blood Loss, Surgical studies recruiting now, 10 (37%) set no upper age limit and 14 (52%) stop at 75 or younger; 6 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
46 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 6 · Phase 3 12 · Phase 4 18
First in 2007; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 90 is above the median of 80 across 160 interventional studies indexed under Blood Loss, Surgical.
Median enrollment 98 across the 46 interventional studies. Of the 27 that completed or were terminated, 8 (30%) have results posted.
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1 of 46 have an industry lead sponsor. The 10 most frequent:
Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Assiut University has 7 studies filed under Blood Loss, Surgical — fewer than ten, so there is no comparison to draw.
3 of the studies testing Tranexamic Acid in Blood Loss, Surgical that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03553186Phase 3Hospital for Special Surgery, New YorkTranexamic Acid in Adult Spinal Deformity Surgery | 2027-03 |
| NCT07565753The University of Texas Health Science Center at San AntonioTEAPOT Study Multisite | 2027-09-30 |
| NCT06580509The University of Texas Health Science Center at San AntonioTranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage: Pilot Study | 2027-09-30 |
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Among the 46 studies testing Tranexamic Acid in Blood Loss, Surgical, from their registry updates:
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The aim of this study is to investigate the effect of preoperative administration of intravenous or nebulized tranexamic acid on surgical field, blood loss, anesthetic consumption and hemodynamics of patients undergoing FESS.
Primary outcome Modena Bleeding Score (MBS) assessing surgical field Secondary outcome
Functional endoscopic sinus surgery (FESS) is the current standard treatment for a variety of conditions affecting the nasal cavity and the paranasal sinuses, such as chronic rhinosinusitis, benign and malignant tumors or cerebrospinal fluid leaks .Being mostly a one-handed technique, FESS does not allow simultaneous use of operative instruments and blood suction, thus endonasal bleeding control represents a challenging issue for the operating surgeon. Such narrow and highly vascularized cavities like the nasal fossae and paranasal spaces can be entirely filled with blood within few seconds, especially if the mucosa is severely inflamed as a consequence of rhinosinusitis. Bleeding is possibly the most relevant factor that could impair the quality of the surgical field during endoscopic procedures. It has been proven that uncontrolled bleeding during endoscopic sinus surgical procedures determines poor visualization of the anatomical landmarks, prolongs surgical time and carries a higher rate of complications .Several techniques to control intraoperative bleeding and improve surgical view during sinus surgery (e.g. topical vasoconstrictors, total intravenous anesthesia, controlled hypotension) have been described and analyzed to determine their efficacy .These types of studies, however, are complex and prone to bias, partially because standardized and validated methods of quantifying bleeding or grading the surgical field in endoscopic view are lacking.
Tranexamic acid functions as the competitive antagonist at the lysine site on plasminogen . During all surgical procedures, the tissue plasminogen activator is released due to tissue damage during surgery, which can convert tissue plasminogen to plasmin, promote fibrinolysis and activate the fibrinolytic system. Thus, tranexamic acid functions as an anti-fibrinolytic agent by inhibiting the tissue plasminogen activator. It can be applied topically or systemically with this mechanism in the coagulation cascade to reduce intraoperative bleeding .The results of several recent studies on endoscopic sinus surgery through topical administration of tranexamic acid are encouraging in terms of the efficacy of tranexamic acid for intraoperative bleeding and other pathological conditions .The purpose of this study is to analyze the efficacy of nebulized tranexamic acid and compare it with intravenous tranexamic acid to improve the surgeon and patient experiences of sinus surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
chronic renal failure
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The protein in red blood cells that carries oxygen. A low level is anemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Tranexamic Acid
Drug: Tranexamic Acid (TXA)
To see if nebulised TXA is better to control blood loss in functional Endoscopic sinus surgery
To see if intravenous TXA is better to control blood loss in functional Endoscopic sinus surgery
Modena Bleeding Score- assessing surgical field
* No bleeding -\>1. * Bleeding easily controlled by suctioning, washing, or packing without any significant modification or slowing of surgical procedure-\>2. * Bleeding slowing surgical procedure-\>3. * Most of the maneuvers dedicated to bleeding control -\>4. * Bleeding that prevents every surgical procedure except those dedicated to bleeding control-\>5.
Time frame: Baseline
Measuring patient's Blood Pressure-> mmhg (unit of measure)
Time frame: Baseline
Measuring patient's Respiratory Rate-> breath per minute(unit of measure)
Time frame: Baseline
Measuring patient's Temperature-> Celsius(unit of measure)
Time frame: Baseline
Measuring patient's Pulse->Beat per minute(unit of measure)
Time frame: Baseline
Measuring End-tidal Co2 by Capnogram
Unit of measure-\> mmhg
Time frame: Baseline
Measuring O2 saturation by the pulse-oximeter
Time frame: Baseline
Measuring amount of intraoperative bleeding through blood volume in suction jar
Time frame: Baseline
Measuring the amount of intraoperative bleeding by counting gauze used in the operation.
Time frame: Baseline
2. Anesthetic consumption, Extra doses of fentanyl and propofol and sevoflurane>2
Time frame: Baseline
Presence or absence of nausea as a Postoperative complication
Time frame: Baseline
Presence or absence of vomiting as a Postoperative complication
Time frame: Baseline
Presence or absence of any form of visual disturbance as a Postoperative complication
Time frame: Baseline
Start is estimated for Jan 2025; primary completion for Dec 2025, 10 months later.
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Studies of the drug tested here: Tranexamic Acid