Hemostatic Effect of Intrauterine Instillation Of Tranexamic Acid In Hysteroscopic Myomectomy

NCT03122782 | Unknown Phase 3

• 1 other identifier: ASU-2016-2
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study Design: Randomized Controlled Clinical Trial. Study Population: The study population will be a consecutive series of participants attending the Early Cancer Detection Unit (ECDU) at Ain Shams University Maternity Hospital. 80 women who are scheduled to undergo a hysteroscopic myomectomy will be included and will be randomized into two groups: Group A: women will undergo a hysteroscopic myomectomy with the use of (TXA) Kapron in the distention medium Group B: women will undergo hysteroscopic myomectomy with the use of placebo(normal saline in the distention medium). Randomization will be performed using a Computer-generated randomization system. The allocated groups will be concealed in serially-numbered sealed opaque envelopes that will only be opened after recruitment. Patient allocation will be performed prior to the induction of anesthesia by an independent person, who will not otherwise be involved in this study. The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used inside the distention medium. Therefore, this study will be a randomized double blind prospective clinical Methodology:

• In intervention group 500 mg of Kapron for every 500 ml of distending media will be added.
• In the control group, placebo .i.e. ,normal saline in the same form will be injected inside every 500 ml of the distention medium.
• The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used inside the distention medium. Therefore, our study will be a randomized double blind prospective clinical trial.
• Intraoperative bleeding and quality of view will be observed.
• A blood sample will be taken from each participant in both groups after 24 hours from the end of the operation for both hemoglobin and hematocrit levels.

Conditions

Surgical Blood Loss; Fibroid

Outcome Measures

Primary Outcomes (2)

• Estimated blood loss by comparing changes in hemoglobin level

  Estimated blood loss by comparing changes in hemoglobin level before hysteroscopic myomectomy (preoperative) and 24 hours after hysteroscopic myomectomy (postoperative) in Tranexamic acid group comparing to the control group

  24 Hours

• Estimated blood loss by comparing changes in hematocrit level

  Estimated blood loss by comparing changes in hematocrit level before hysteroscopic myomectomy (preoperative) and 24 hours after hysteroscopic myomectomy (postoperative) in the Tranexamic acid group comparing to the control group

  24 hours

Study Arms (2)

Tranexamic acid (TXA) Group

ACTIVE COMPARATOR

Subjects in the Tranexamic acd (TXA) group will receive intrauterine instillation of 500 mg (100mg/ml) Tranexamic acid per 500 ml normal salin (distention medium) during Hysteroscopic Myomectomy.

Drug: Topical application Tranexamic acid

Normal Saline (control group)

PLACEBO COMPARATOR

Subjects in the control group will receive 500 ml intrauterine instillation of normal saline with the distention medium (normal saline) during Hysteroscopic Myomectomy.

Drug: Placebo (Normal saline)

Interventions

Topical application Tranexamic acid DRUG

Tranexamic acid (TXA) will be injected to distinction media during hysteroscopy in myomectomy

Also known as: KAPRON (AMOUN Pharmaceutical co.)

Tranexamic acid (TXA) Group

Placebo (Normal saline) DRUG

5ml of normal saline will be added to every 500 ml of distension media

Normal Saline (control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be able to understand, and read and sign the study specific informed consent after fully explanation the nature of the study .
• Subjects exhibit submucous myoma that are completely within the endometrial cavity or extend less than 50 percent into the myometrium (type 0,i)according to European Society Of Hysteroscopy (ESH).
• The submucous myoma are less than 4 cm in diameter

You may not qualify if:

• Pregnancy
• Active Pelvic Infection
• Present or History of Cervical or Uterine Caner
• Bleeding Diathesis or patient on anticoagulant
• Contraindication and /or allergy to medication specified in the treatment protocol
• History of ischemic heart disease
• Patient with Cardiopulmonary, Hepatic , and renal diseases
• Patient with metabolic disorders including diabetes
• Patients with uterine septum or structural abnormality

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Blood Loss, Surgical; Leiomyoma

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ahmed Khairyy Makled, MD

  Ain Shams University

  STUDY CHAIR

• Amgad Said Abu-Gamra, MD

  Ain Shams University

  STUDY CHAIR

• Radwa Ali Rasheedy, MD

  Ain Shams University

  STUDY DIRECTOR

• Hajer Giuma Soliman, M.B.B.CH

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radwa Ali Rasheedy, MD

CONTACT

01283492979; Radwaebed@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: April 21, 2017
• Study Start: August 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: January 1, 2018
• Last Updated: June 29, 2017

Record last verified: 2017-03