Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 96 of 419 for:    TRANEXAMIC ACID

Hemostatic Effect of Intrauterine Instillation Of Tranexamic Acid In Hysteroscopic Myomectomy

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: NCT03122782
Recruitment Status : Unknown
Verified March 2017 by Hajer Soliman, Ain Shams University.
Recruitment status was:  Not yet recruiting
First Posted : April 21, 2017
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
Hajer Soliman, Ain Shams University

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:

  1. Informed written consent obtained from the participant.
  2. History

    1. Personal history
    2. Menstrual history
    3. Detailed obstetric history
    4. Surgical intervention especially uterine surgeries and any post-operative complication
    5. History of drug intake, especially hormonal treatment or anticoagulant therapy.
  3. Routine preoperative investigations in addition to a serum pregnancy test if pregnancy is suspected.
  4. Physical examination including general, abdominal and pelvic examination.
  5. Hysteroscopy will be performed in the early proliferative phase using normal saline as a distention medium.
  6. Only in intervention group (TXA group) KAPRON (Tranexamic acid) will be added to the injected media.

    • 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.
  7. 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.
  8. Intraoperative bleeding and quality of view will be observed.
  9. 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.

Types of outcome measures:

Primary outcome measures:

Estimated Blood loss defined as comparing the hematocrit and hemoglobin at base line (preoperative ) and 24 hours after surgery with the Tranexamic acid compared to the control group.

Secondary outcome measures:

The quality of view, duration of surgery, the volume of injected media, intraoperative complications and the success of the completion of the operation will be secondary outcomes.


Condition or disease Intervention/treatment Phase
Surgical Blood Loss Fibroid Drug: Topical application Tranexamic acid Drug: Placebo (Normal saline) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Hemostatic Effect of Intrauterine Instillation Of Tranexamic Acid In Hysteroscopic Myomectomy
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tranexamic acid (TXA) Group
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
Tranexamic acid (TXA) will be injected to distinction media during hysteroscopy in myomectomy
Other Name: KAPRON (AMOUN Pharmaceutical co.)

Placebo Comparator: Normal Saline (control group)
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)
5ml of normal saline will be added to every 500 ml of distension media




Primary Outcome Measures :
  1. Estimated blood loss by comparing changes in hemoglobin level [ Time Frame: 24 Hours ]
    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

  2. Estimated blood loss by comparing changes in hematocrit level [ Time Frame: 24 hours ]
    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



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must be able to understand, and read and sign the study specific informed consent after fully explanation the nature of the study .
  2. 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).
  3. The submucous myoma are less than 4 cm in diameter

Exclusion Criteria:

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

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): NCT03122782


Contacts
Layout table for location contacts
Contact: Radwa Ali Rasheedy, MD 01283492979 Radwaebed@yahoo.com

Sponsors and Collaborators
Ain Shams University
Investigators
Layout table for investigator information
Study Chair: Ahmed Khairyy Makled, MD Ain Shams University
Study Chair: Amgad Said Abu-Gamra, MD Ain Shams University
Study Director: Radwa Ali Rasheedy, MD Ain Shams University
Principal Investigator: Hajer Giuma Soliman, M.B.B.CH Ain Shams University

Layout table for additonal information
Responsible Party: Hajer Soliman, Resident, Ain Shams University
ClinicalTrials.gov Identifier: NCT03122782     History of Changes
Other Study ID Numbers: ASU-2016-2
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: March 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Blood Loss, Surgical
Hemorrhage
Pathologic Processes
Intraoperative Complications
Tranexamic Acid
Hemostatics
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Coagulants