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

Effect of Topical and Systemic Tranexemic Acid on Bleeding and Quality of Surgical Field During Ear Exploration Surgery. A Double Blind Randomized Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Intraoperative Bleeding
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: Tranexamic Acid; Drug: Adrenalin

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Asyut, Egypt, 71111
    • Recruiting
    • Egypt
    • Contact: Sally Ahmed, Dr; Phone Number: 088 01068668302; Email: Sallyahmed720@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: kapron; Drug: Tranexamic Acid; Topical TXA 1 gm diluted in 200 ml saline; Other Names: kapron
ACTIVE_COMPARATOR: Topical TXA; Topical TXA 1 gm diluted in 200 ml saline	Drug: Tranexamic Acid; TXA of 10-15 mg i.v over 30 min. followed by infusion in adose of 1 mg / kg /hr; Other Names: kapron; Drug: Tranexamic Acid; Topical TXA 1 gm diluted in 200 ml saline; Other Names: 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 Names: Epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The quality of the surgical field	Boezaart grading with 0-5 scores.	45 minutes after the start of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative blood loss	Blood in the suction and the gauze	45 minutes after the start of surgery

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Sally Ahmed, Dr, Assiut Univerisity

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2017
• Primary Completion (ANTICIPATED): January 1, 2018
• Study Completion (ANTICIPATED): January 1, 2018

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (ACTUAL): April 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Fibrin Modulating Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Tranexamic Acid; Epinephrine
• Other Study ID Numbers: assuit university hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No