An interventional study of Tranexamic Acid and Epinephrine in Intraoperative Bleeding, sponsored by Assiut University. Completed at 2 sites in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-04-21.
Sponsored by Assiut University · Not applicable, Interventional, and Prevention
Exploratory tympanotomy is surgical access to the middle ear, made for diagnosis and management of unexplained conductive hearing loss, performed under an oto-microscope across the external auditory canal after tympanic membrane elevation to explore the middle ear structures
Epinephrine is a vasoconstrictor searched intensively for ptimization of the surgical field during microscopic ear and sinus surgeries with controversial results given the possible cardiovascular complication in case of systemic absorption,especially in vulnerable cardiac patients.Tranexamic acid (TXA) as an antifibrinolytic medication is used to treat or prevent excessive bleeding in significant trauma, surgery, tooth removal, or nasal bleeding, discovered by Japanese researchers. TXA, given either oral or intravenous, is a derivative of lysine amino acid; it acts reversibly on the lysine binding sites to block it on the plasminogen molecules. TXA consequently hinders the stimulation of plasminogen competitively, thus reduces its conversion into plasmin. Plasminogen is the enzyme that leads to the degradation of a fibrin clot, fibrinogen, and other plasma proteins, such as factors V and VIII. More than 95% of TXA intravenous administered dose eliminated unchanged through the urinary system. Twenty-four hours after intravenous administration of TXA has demonstrated accumulative excretion of approximately 90%, whereas only 3% is bound to plasminogen. TXA is minimally excreted in breast milk while it can freely cross the blood brain barrier and the placenta .
218 studies on the registry are indexed under Blood Loss, Surgical; 39 are open to participants now.
This study's enrollment of 60 is below the median of 90 across 157 interventional studies indexed under Blood Loss, Surgical.
Browse Blood Loss, Surgical studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
received topical 1 gram of TXA diluted in 200 ml of normal saline (0.9%) for topical use to rinse the bleeding sites and soak the used gauze for local compression.
Drug: Tranexamic Acid
received Epinephrine 1 mg diluted in 200 ml normal saline (0.9%) for topical use to rinse the bleeding sites and soak the used gauze for local compression.
Drug: Epinephrine
received topical 1 gram of TXA diluted in 200 ml of normal saline (0.9%) for topical use to rinse the bleeding sites and soak the used gauze for local compression.
received Epinephrine 1 mg diluted in 200 ml normal saline (0.9%) for topical use to rinse the bleeding sites and soak the used gauze for local compression.
State of surgical field categorized by surgeons based on Boezaart classification
Grade Description 0 No bleeding (cadaveric conditions) 1. Slight bleeding: no suctioning required 2. Slight bleeding: occasional suctioning required 3. Slight bleeding: frequent suctioning required, bleeding threatens surgical field a few seconds after suction is removed 4. Moderate bleeding: frequent suctioning required and bleeding threatens surgical field directly after suction is removed 5. Severe bleeding: constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible
Time frame: 2 hour
bleeding volume
The quantity of blood (ml) = (mass of used + fresh gauze - weight of all sponges before surgery) / 1.05.
Time frame: 2 hour
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Assiut University