Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

IV Tranexamic Acid Prior to Hysterectomy

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02911831
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Magdy Milad, MD, Northwestern University

Brief Summary:
The objective of this study is to determine the effect of 1g of IV tranexamic acid given within 1 hour pre-operatively on intraoperative blood loss at time of hysterectomy.

Condition or disease Intervention/treatment Phase
Hysterectomy Blood Loss, Surgical Drug: Tranexamic Acid Drug: Sodium Chloride Early Phase 1

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: IV Tranexamic Acid Prior to Hysterectomy for Reduction of Intraoperative Blood Loss: A Randomized Placebo-Controlled Trial
Actual Study Start Date : November 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tranexamic Acid: Abdominal Hysterectomy

Agent/Device: Tranexamic acid. Patients undergoing abdominal hysterectomy who consent to the study may be randomized to this arm.

· Protocol dose: 1g in solution to be given intravenously, within 1 hour prior to procedure

Drug: Tranexamic Acid
Other Name: TXA

Placebo Comparator: Sodium chloride (placebo): Abdominal Hysterectomy

Agent/Device: 0.9% sodium chloride solution. Patients undergoing abdominal hysterectomy who consent to the study may be randomized to this arm.

· Protocol dose: 100ml to be given intravenously, within 1 hour prior to procedure

Drug: Sodium Chloride
Other Name: Normal saline




Primary Outcome Measures :
  1. Intra-operative blood loss [ Time Frame: Intra-operative ]

Secondary Outcome Measures :
  1. Change in hemoglobin, postoperative from baseline [ Time Frame: < 12 hours ]
  2. Need for blood transfusion [ Time Frame: Intra-operative ]
  3. Length of hospital stay [ Time Frame: <1 week ]
  4. Length of operative procedure [ Time Frame: <12 hours ]
  5. Rates of postoperative thromboembolic events [ Time Frame: 12 weeks ]
  6. Incidence of drug-related adverse events [ Time Frame: 12 weeks ]
  7. Health care cost [ Time Frame: 12 weeks ]


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. Patients presenting for hysterectomy for any benign indication including but not limited to abnormal uterine bleeding, menorrhagia, uterine fibroids, adenomyosis, pelvic pain, dysmenorrhea, pelvic organ prolapse or endometriosis.
  2. Age ≥ 18 years
  3. Pre-operative hemoglobin >8 g/dl
  4. Willing to have IV tranexamic acid or a placebo prior to hysterectomy
  5. Ability to understand and the willingness to sign a written informed consent.
  6. Can be previously treated with Depo-Lupron, Depo-Provera, Oral Contraceptive pills, Mirena IUD, endometrial ablation, myomectomy, oral progestins
  7. Hysterectomy in combination with the following procedures is permitted: unilateral/bilateral salpingectomy or oophorectomy, ovarian cystectomy, fulguration/excision of endometriosis, appendectomy, sacrocolpopexy, anterior/posterior repair, uterosacral vault suspension, retropubic midurethral sling and cystoscopy

Exclusion Criteria:

  1. Patients with known or suspected endometrial/ovarian/cervical cancer.
  2. Patients undergoing hysterectomy for endometrial hyperplasia or cervical dysplasia.
  3. Patients currently undergoing treatment for any type of cancer.
  4. Patients with known bleeding/clotting disorders or a history of thromboembolism (including deep venous thrombosis or pulmonary embolism)
  5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to tranexamic acid.
  6. Any procedures which occur in combination with other elective surgical procedures (such as abdominoplasty, breast augmentation, etc) which are not included in the previously mentioned inclusion criteria above will be excluded from data analysis.
  7. Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, subarachnoid hemorrhage, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  8. Patients with acquired defective color vision
  9. Patients with known renal failure and/or Cr > 5 within the last 6 months

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): NCT02911831


Contacts
Layout table for location contacts
Contact: Magdy P Milad, MD, MS 312-472-4673 Mmilad@nm.org

Locations
Layout table for location information
United States, Illinois
Northwestern University - Northwestern Medicine, Lavin Family Pavillion Recruiting
Chicago, Illinois, United States, 60611
Contact: Magdy Milad, MD    312-472-4673    mmilad@nm.org   
Contact: Megan A Runge    312-503-3492    megan.runge@northwestern.edu   
Principal Investigator: Magdy Milad, MD,MS         
Sponsors and Collaborators
Northwestern University
Investigators
Layout table for investigator information
Principal Investigator: Magdy Milad, MD Northwestern University, Northwestern Memorial Hopsital
Publications:
Okamoto S, Okamoto U. Amino-methyl-cyclohexane-carboxylic acid: AMCHA: a new potent inhibitor of fibrinolysis. Keio J Med. 1962;11:105-115.
FDA Information on Cyklokapron (tranexamic acid injection) Retrieved11/15/2015, from http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019281s030lbl.pdf

Layout table for additonal information
Responsible Party: Magdy Milad, MD, Chief of Minimally Invasive Gynecologic Surgery in the Department of Obstetrics and Gynecology Albert B. Gerbie, MD, Professor of Obstetrics and Gynecology Professor of Obstetrics and Gynecology (Minimally Invasive Gynecologic Surgery), Northwestern University
ClinicalTrials.gov Identifier: NCT02911831    
Other Study ID Numbers: STU00203110
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020

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