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

• ClinicalTrials.gov Identifier: NCT03112135
• Recruitment Status: Unknown
• First Posted: April 13, 2017
• Last Update Posted: April 13, 2017
• Sponsor: Assiut University
• Information provided by (Responsible Party): Sally Ahmed kamel, Assiut University

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

Egypt

Egypt; Recruiting

Asyut, Egypt, 71111

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

Sponsors and Collaborators

Assiut University

Investigators

• Principal Investigator: Sally Ahmed, Dr; Assiut Univerisity

More Information

• 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
• Last Update Posted: April 13, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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