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Trial record 94 of 419 for:    TRANEXAMIC ACID

Does The Combined Use Of Local And Intravenous Tranexamic Acid Offer Better Surgical Field Quality During Functional Endoscopic Sinus Surgery? A Placebo-Controlled Clinical Trial

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ClinicalTrials.gov Identifier: NCT03965767
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Ossama Mustafa Mady, Ain Shams University

Brief Summary:

Functional Endoscopic Sinus surgery (FESS) is a surgery done for chronic rhinosinusitis after failure of medical treatment. Intraoperative bleeding poses a challenge to both the surgeon and anaesthetist. Although blood loss is not massive during FESS, bleeding may obscure the surgical field prolonging the time of surgery or even leading to incompletion of the surgery.

Different methods have been used to improve the surgical field but none without side effects. The use of diathermy carries the risk of local tissue damage with the risk of subsequent bleeding. Local vasoconstrictors carry the risk of systemic absorption. Induced hypotension may not be suitable for all patients; besides, this may necessitates the use of more anaestheic drugs with their associated side effects. In addition, none of theses methods have provided ideal surgical field for the surgeon.1-3 Tranexamic acid, an antifibrinolytic agent, has been used to decrease surgical field bleeding in different surgeries showing effectiveness in its topical, oral and intravenous use.4-6 The aim of this study is to evaluate the effectiveness of local, intravenous and combined use of tranexamic acid in improving the surgical field quality during functional endoscopic sinus surgery.


Condition or disease Intervention/treatment Phase
Chronic Sinus Disease Nasal Polyps Drug: Tranexamic Acid Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Does The Combined Use Of Local And Intravenous Tranexamic Acid Offer Better Surgical Field Quality During Functional Endoscopic Sinus Surgery? A Placebo-Controlled Clinical Trial
Actual Study Start Date : April 25, 2019
Estimated Primary Completion Date : August 25, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Placebo Comparator: control Drug: Tranexamic Acid
comparison of effect of tranexamic acid on control of bleeding when used locally in the nose or systemic use

Active Comparator: local group Drug: Tranexamic Acid
comparison of effect of tranexamic acid on control of bleeding when used locally in the nose or systemic use

Active Comparator: systemic group Drug: Tranexamic Acid
comparison of effect of tranexamic acid on control of bleeding when used locally in the nose or systemic use

Active Comparator: combined local and systemic Drug: Tranexamic Acid
comparison of effect of tranexamic acid on control of bleeding when used locally in the nose or systemic use




Primary Outcome Measures :
  1. bleeding during surgery [ Time Frame: time of surgery ]
    surgeon satisfaction



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients underwent endoscopic sinus surgery

Exclusion Criteria:

  • patients with uncontrolled hypertension or coronary artery disease, anaemia, end stage renal failure, liver cirrhosis, patients with coagulopathy or receiving drugs influencing blood coagulation, cerebrovascular thrombosis or history of thrombotic events, pregnancy, known sensitivity to any of the study drug and patients' refusal to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965767


Contacts
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Contact: Research ethics comittee 26857539 ext 202 fathytash@yahoo.com

Locations
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Egypt
Faculty of Medicine Ain Shams University Recruiting
Cairo, Egypt
Contact: ossama mady, MD    01117341201 ext 202    omady84@gmail.com   
Sponsors and Collaborators
Ain Shams University

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Responsible Party: Ossama Mustafa Mady, Ain Shams University
ClinicalTrials.gov Identifier: NCT03965767     History of Changes
Other Study ID Numbers: FMASU R 27-2019
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ossama Mustafa Mady, Ain Shams University:
endoscopic sinus surgery- tranexamic acid
Additional relevant MeSH terms:
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Tranexamic Acid
Nasal Polyps
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants