Role of Blood Management in Perioperative Outcomes

NCT04475497 | Terminated

• 1 other identifier: 20-464
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Blood mangement

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin level

  Preoperative hemoglobin minus postoperative hemoglobin

  4-months

Secondary Outcomes (9)

• Operative time

  1-day

• Blood loss

  1-day

• Perioperative transfusion rate

  3-days

• Length of hospital stay

  3-days

• Intraoperative complications

  30-days

Study Arms (2)

Blood mangement group

EXPERIMENTAL

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: Blood management

Usual care

ACTIVE COMPARATOR

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

Other: Usual care

Interventions

Blood management OTHER

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.

Blood mangement group

Usual care OTHER

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

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rosanne Kho, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 17, 2020
• Study Start: July 24, 2020
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2023
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

US (1)