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Intraoperative BleedingPhase 2NCT03112135

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

A Phase 2 study testing Tranexamic Acid and Adrenalin in people with Intraoperative Bleeding, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Intraoperative Bleeding
What is being tested?
Tranexamic Acid and Adrenalin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteEgypt
Study dates
Apr 2017to Jan 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • Patient refusal
  • allergy toTXA
  • Bleeding disorder
  • psychiatric illness
  • acute and chronic renal failure
  • using heparin during 48 hr before surgery
Show all 10Show fewer
  • pregnancy
  • cirrhosis
  • colour blindness
  • cardiac stent

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Egypt

    Asyut, Asyut Governorate, 71111

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

    Recruiting

Other trials in Egypt

About this study

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

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.

Read the 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.

Being tested
Tranexamic Acid, Adrenalin
Medical subject headings
Blood Loss, Surgical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic AcidDrug

    Also called kapron

    TXA of 10-15 mg i.v over 30 min. followed by infusion in adose of 1 mg / kg /hr

  • Tranexamic AcidDrug

    Also called kapron

    Topical TXA 1 gm diluted in 200 ml saline

  • AdrenalinDrug

    Also called Epinephrine

    Topical adrenaline 1 mg diluted on 200 ml saline

Study groups in NCT03112135
Study groupRoleWhat they receive
Systemic TXAActive comparatorTXA 10-15 mg i.v over 30 min. followed by infusion in a dose of 1 mg / kg /hr
Receives: Drug: Tranexamic Acid
Topical TXAActive comparatorTopical TXA 1 gm diluted in 200 ml saline
Receives: Drug: Tranexamic Acid
Topical adrenalineActive comparatorTopical adrenaline 1 mg diluted in 200 ml saline
Receives: Drug: Adrenalin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The quality of the surgical field

    Boezaart grading with 0-5 scores.

    Measured: 45 minutes after the start of surgery

Secondary outcomes (1)
  1. intraoperative blood loss

    Blood in the suction and the gauze

    Measured: 45 minutes after the start of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2017
  2. Study startApr 2017 (estimated)
  3. Primary completionJan 2018 (estimated)
  4. Study completionJan 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03112135
Sponsor's protocol ID
assuit university hospital
Status last verified
Apr 2017
First submitted
6 Mar 2017
Last updated
13 Apr 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tranexamic Acid and Adrenalin in people with Intraoperative Bleeding, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sally Ahmed, Dr (01068668302 ext. 088, Sallyahmed720@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The quality of the surgical field (time frame: 45 minutes after the start of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.

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