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This is a Double-blinded randomized placebo-controlled trial based at Eastern Virginia Medical School. Subjects who are identified in clinic having menorrhagia or abnormal Uterine bleeding (AUB) due to uterine fibroids and meet inclusion criteria based on the ultrasound (US) or Magnetic Resonance Imaging (MRI), aged 18-45 undergoing laparoscopic or Robotic assisted myomectomies. A total of 50 women in each arm of the study with symptomatic fibroids. Patients will be randomized to receive a single IV bolus injection of TXA 30mg/kg in 50ml of normal saline (intervention group) versus an IV bolus injection of normal saline of equivalent volume (placebo group) 15 minutes prior to initial surgical incision.
This is a Double-blinded randomized placebo-controlled trial based at Eastern Virginia Medical School. Subjects who are identified in clinic having menorrhagia or abnormal Uterine bleeding (AUB) due to uterine fibroids and meet inclusion criteria based on the ultrasound (US) or Magnetic Resonance Imaging (MRI), aged 18-45 undergoing laparoscopic or Robotic assisted myomectomies. These subjects will be then approached for consent during their pre-op visit 1-2 weeks prior to their surgery. The setting for consent will be in a patient consultation room. A total of 50 women in each arm of the study with symptomatic fibroids meeting any of the following criteria will be included in the study:
Both surgeon and patient will be blinded to the treatment arm. This dosage has been used previously in both obstetric and gynecological procedures and is the same dose recommended by the WHO for preventing post-partum hemorrhage The surgery itself will be scheduled at either Sentara Norfolk General, Sentara Leigh hospital, and Sentara Princess Anne hospital. These are the three sites that the investigators already perform Minimally invasive myomectomies.
An envelope will be given to the anesthesiologist prior to the procedure informing whether they are to receives TXA or the placebo. Blood loss will be estimated by the surgeon performing the procedure. Hemoglobin and hematocrit will be obtained 24 hours post procedure. The patient will be assessed for reported side effects from the medication given will be assessed by a questionnaire that will be given at their post-op appointment at the 2 week and 6-week mark. During these two visits a physical exam is performed, checking incision sites, and patient symptoms, all of which are standard of care for any minimally invasive procedure. The patients will be seen at the EVMS outpatient clinic for Gynecology, or depending with the physician who performed the surgery. Data will be collected from both Allscripts and EPIC charts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid | Experimental | Patients will receive a single IV bolus injection of TXA 30mg/kg in 50ml of normal saline 15 minutes prior to initial surgical incision time |
|
| Placebo | Placebo Comparator | Patients will receive an IV bolus injection of normal saline of equivalent volume (placebo group) 15 minutes prior to initial surgical incision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | IV Tranexamic acid in 50 ml will be given 15 minutes prior to initial surgical incision in the placebo group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated blood loss | Estimated blood loss at time of procedure completion; using volume of cannister and weight of lap sponges | Duration of procedure up to 420 minutes |
| Calculated blood loss | Calculated Blood loss, using pre-operative hematocrit, postoperative hematocrit and estimated blood volume x Body Mass Index | From post operative day 0 until postoperative day 1 |
| Number of blood products received | Number of blood products received during admission that is directly due to blood loss at time of procedure | Duration of hospital stay up to two days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of surgery | Start time of procedure until end time of procedure | Duration of surgery up to 420 minutes |
| Length of hospital stay | Recorded in days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seifeldin Sadek, MD | Contact | 7574467100 | sadeks@evms.edu | |
| Traci Ito, MD | Contact | 7574467900 | itoTE@evms.edu |
| Name | Affiliation | Role |
|---|---|---|
| Seifeldin Sadek, MD | Eastern Virginia Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EasternVMC | Recruiting | Norfolk | Virginia | 23507 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28099726 | Background | Topsoee MF, Settnes A, Ottesen B, Bergholt T. A systematic review and meta-analysis of the effect of prophylactic tranexamic acid treatment in major benign uterine surgery. Int J Gynaecol Obstet. 2017 Feb;136(2):120-127. doi: 10.1002/ijgo.12047. Epub 2016 Dec 9. | |
| 26002266 | Background | Moore EE, Moore HB, Gonzalez E, Chapman MP, Hansen KC, Sauaia A, Silliman CC, Banerjee A. Postinjury fibrinolysis shutdown: Rationale for selective tranexamic acid. J Trauma Acute Care Surg. 2015 Jun;78(6 Suppl 1):S65-9. doi: 10.1097/TA.0000000000000634. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 2, 2020 | Mar 13, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 12, 2020 | Mar 13, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D008796 | Metrorrhagia |
| D047708 | Myofibroma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Randomized Double Blind Placebo clinical trial
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| Placebos | Drug | IV normal saline 50 ml will be given 15 minutes prior to initial surgical incision in the placebo group. |
|
| Duration of stay in hospital, up to two days |
| Number of fibroids removed | Total number of fibroids removed during procedure | Duration of surgery, up to 420 minutes |
| Fibroid type | type of fibroid per FIGO classification | through completion of study average 8 weeks |
| Weight of fibroids removed | total weight of fibroids removed | duration of surgery up to 420 minutes |
| Pain index | Pain index score on postoperative day 1 and 14 Score of 0-10 0 = no pain, 10 = significant amount of pain | duration of hospital stay, up to two days |
| Incidence of postoperative complication | Immediate postoperative complication: Hemorrhage Infection Fever Deep vein thrombosis Hysterectomy Re-exploration Hospital readmission | Duration of hospital stay , up to two days |
| Questionnaire for incidence of mild side effect of medication | Reported mild effective of medication of post operative day 1 | only on postoperative day 1 , one day |
| Questionnaire for incidence of serious side effect of medication | Reported serious side effect of medication on post operative day 1 | Only on postoperative day 1, one day |
| tPA receptor | Percentage of tPA receptor located in fibroid and myometrium | From time of randomization until postoperative visit, four weeks |
| PAI-1 receptor | Percentage of PAI-1receptor located in fibroid and myometrium | From time of randomization until postoeprative visit, four weeks |
| 26855249 | Background | Hickman LC, Kotlyar A, Shue S, Falcone T. Hemostatic Techniques for Myomectomy: An Evidence-Based Approach. J Minim Invasive Gynecol. 2016 May-Jun;23(4):497-504. doi: 10.1016/j.jmig.2016.01.026. Epub 2016 Mar 9. |
| 21249650 | Background | Henry DA, Carless PA, Moxey AJ, O'Connell D, Stokes BJ, Fergusson DA, Ker K. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2011 Jan 19;(1):CD001886. doi: 10.1002/14651858.CD001886.pub3. |
| 25125317 | Background | Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5. |
| 27679021 | Background | Opoku-Anane J, Vargas MV, Moawad G, Cherie M, Robinson JK. Use of Intravenous Tranexamic Acid During Myomectomy: A Randomized Double-Blind Placebo Controlled Trial. J Minim Invasive Gynecol. 2015 Nov-Dec;22(6S):S197. doi: 10.1016/j.jmig.2015.08.715. Epub 2015 Oct 15. No abstract available. |
| 17658523 | Background | Parker WH. Uterine myomas: management. Fertil Steril. 2007 Aug;88(2):255-71. doi: 10.1016/j.fertnstert.2007.06.044. Epub 2007 Jul 20. |
| 24705132 | Background | Lam SJ, Best S, Kumar S. The impact of fibroid characteristics on pregnancy outcome. Am J Obstet Gynecol. 2014 Oct;211(4):395.e1-5. doi: 10.1016/j.ajog.2014.03.066. Epub 2014 Apr 3. |
| 29630190 | Background | WHO Recommendation on Tranexamic Acid for the Treatment of Postpartum Haemorrhage. Geneva: World Health Organization; 2017. Available from http://www.ncbi.nlm.nih.gov/books/NBK493081/ |
| 26568770 | Background | Ngichabe S, Obura T, Stones W. Intravenous tranexamic acid as an adjunct haemostat to ornipressin during open myomectomy. A randomized double blind placebo controlled trial. Ann Surg Innov Res. 2015 Oct 31;9:10. doi: 10.1186/s13022-015-0017-y. eCollection 2015. |
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009372 | Neoplasms, Connective Tissue |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |