TerminatedNot Applicable

Role of Blood Management in Perioperative Outcomes

Stopped: Lack of enrollment

United States18 participantsStarted 2020-07-24

Plain-language summary

There is currently limited information regarding the role of blood management in the benign gynecologic population and specifically, in patients who are scheduled to undergo surgery for fibroids and/or abnormal uterine bleeding. A thorough search through PubMed and clinicaltrials.gov did not reveal any studies on this issue. In 2019 at CCF only 2% of gyn patients at Main Campus were referred to blood management, but 12.6% of the main campus gyn population had a Hb of \<10.0 g/dL. The overall goal of this study is to evaluate the role of preoperative blood management in optimizing surgical outcomes by reducing the co-morbidities associated with postoperative blood transfusion.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Anemic patients (defined as Hgb \< 11g/dL within 30 days of initial consult visit) * Greater than 18-years of age with abnormal uterine bleeding or fibroids * Scheduled for gynecologic surgery (myomectomy or hysterectomy by laparoscopic, robotic, vaginal or open routes) Exclusion Criteria: * Malignancy * Pregnancy * Sickle cell anemia or other blood dyscrasias * Women who received blood transfusions within 30 days prior to surgery * Women receiving EPO therapy * Women who have undergone gastric bypass surgery * Women on therapeutic/full anticoagulation * Patients undergoing hysteroscopic myomectomy alone without will not be included in the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in hemoglobin level

Timeframe: 4-months

Trial details

NCT IDNCT04475497

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-18

View on ClinicalTrials.gov More Abnormal Uterine Bleeding trials