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Effect of Topical and Systemic Tranexemic Acid on Bleeding During Ear Exploration Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03112135
Recruitment Status : Unknown
Verified April 2017 by Sally Ahmed kamel, Assiut University.
Recruitment status was:  Recruiting
First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Sally Ahmed kamel, Assiut University

Brief Summary:
The effect of tranexamic acid (TXA) on bleeding and improvement of surgical field during ear exploration surgery is not clear yet. This study will conducted to answer this question.

Condition or disease Intervention/treatment Phase
Intraoperative Bleeding Drug: Tranexamic Acid Drug: Adrenalin Phase 2

Detailed Description:

Bleeding during ear surgery is still a challenge for surgeons and anesthesiologists . Although extensive blood loss is rare during ear surgery, however, establishing a favorite surgical field is often difficult. The reason is that even slight bleeding may distort the view of the field and increase the occurrence of complications, including deafness, the longer duration of surgery, or even inconclusive surgery .

Many techniques have been proposed to improve the field of ear exploration surgery. Bipolar diathermy, packing, local vasoconstrictors, and induced hypotension are the most commonly used techniques . Diathermy can lead to local damage and delayed bleeding . Using topical vasoconstrictions can lead to hemodynamic instability especially in patients with a history of hypertension or ischemic heart disease. Induction hypotension exposes the patients to more anesthetic drugs and hence a higher risk of potential side effects. However, neither of these methods guarantees a desirable surgical field with no bleeding. Therefore, investigators are working on more effective and safer methods to reduce bleeding and hence to improve the field of surgery .

Activation of fibrinolysis during and after surgery is a well-known phenomenon. Many mechanisms associated with coagulation disorders, such as surgical trauma, blood loss and consumption of coagulation factors and platelets, using crystalloid and colloid given during and after surgery, hypothermia, acidosis, foreign materials, and etc. In recent studies, systemic infusion of anti-fibrinolytic drugs have been used to reduce bleeding in various forms of surgery such as major orthopedic surgery,and adeno-tonsillectomy.

Tranexamic acid (TXA) is a synthetic antifibrinolytic agent that binds to the lysine binding sites of plasmin and plasminogen. Saturation of the binding sites causes separation of plasminogen from superficial fibrin and hence prevents fibrinolysis. Any surgical procedure can cause a considerable tissue damage and hence trigger the release of enzymes, such as 'tissue plasminogen activator' that converts plasminogen to plasmin and activates fibrinolysis process. TXA can prevent fibrinolysis activity by inhibiting the activity of this enzyme.

Systemic infusion of TXA associated with several potential side effects such as nausea, vomiting, diarrhea, allergic dermatitis, dizziness, hypotension, seizures, impaired vision, achromatopsia (impaired color vision), and particularly thromboembolic events. Several studies have been conducted on topical TXA in different types of surgery but no systemic absorption or side effects have been reported.

To date, the effect of TXA on reduction of bleeding in ear surgery is unclear . There is no consensus on the efficacy of TXA and its effective dose in reducing bleeding. This trial will aim to assess the effect of topical TXA on bleeding and improvement of surgical field during ear surgery in patients with chronic ear disease.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Topical and Systemic Tranexemic Acid on Bleeding and Quality of Surgical Field During Ear Exploration Surgery. A Double Blind Randomized Clinical Trial
Estimated Study Start Date : April 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Epinephrine

Arm Intervention/treatment
Active Comparator: Systemic TXA
TXA 10-15 mg i.v over 30 min. followed by infusion in a dose of 1 mg / kg /hr
Drug: Tranexamic Acid
TXA of 10-15 mg i.v over 30 min. followed by infusion in adose of 1 mg / kg /hr
Other Name: kapron

Active Comparator: Topical TXA
Topical TXA 1 gm diluted in 200 ml saline
Drug: Tranexamic Acid
Topical TXA 1 gm diluted in 200 ml saline
Other Name: kapron

Active Comparator: Topical adrenaline
Topical adrenaline 1 mg diluted in 200 ml saline
Drug: Adrenalin
Topical adrenaline 1 mg diluted on 200 ml saline
Other Name: Epinephrine




Primary Outcome Measures :
  1. The quality of the surgical field [ Time Frame: 45 minutes after the start of surgery ]
    Boezaart grading with 0-5 scores.


Secondary Outcome Measures :
  1. intraoperative blood loss [ Time Frame: 45 minutes after the start of surgery ]
    Blood in the suction and the gauze



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. being candidate for ear exploration surgery.
  2. ASA I-II
  3. Willing to participate in the study
  4. Hb level > 10 mg/dl.
  5. normal coagulation profile (INR and PTT )

Exclusion Criteria:

  1. Patient refusal
  2. allergy toTXA
  3. Bleeding disorder
  4. psychiatric illness
  5. acute and chronic renal failure
  6. using heparin during 48 hr before surgery
  7. pregnancy
  8. cirrhosis
  9. colour blindness
  10. cardiac stent

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): NCT03112135


Contacts
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Contact: Sally Ahmed, Dr 01068668302 ext 088 Sallyahmed720@gmail.com

Locations
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Egypt
Egypt Recruiting
Asyut, Egypt, 71111
Contact: Sally Ahmed, Dr    01068668302 ext 088    Sallyahmed720@gmail.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Sally Ahmed, Dr Assiut Univerisity
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Responsible Party: Sally Ahmed kamel, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03112135    
Other Study ID Numbers: assuit university hospital
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
Epinephrine
Tranexamic Acid
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants