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Role of Blood Management in Perioperative Outcomes

NCT04475497 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-09-05

No results posted yet for this study

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.

Conditions

  • Abnormal Uterine Bleeding

Interventions

OTHER

Blood management

The intervention will include pre-surgical optimization blood management referral based on pre-operative Hgb levels \<11.0 g/dL. Treatment will include PO iron, IV iron, B12 or folate per blood management algorithm.

OTHER

Usual care

Usual care per surgeon preference can include iron by mouth or no iron therapy.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Rosanne Kho, M.D. · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-24
Primary Completion
2023-05-18
Completion
2023-05-18

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04475497 on ClinicalTrials.gov