NCT02411396

Brief Summary

The Emergency Department has been the standard location where patients with Sickle Cell Disease (SCD) go to seek care for the treatment of acute painful events. Vaso- Occlusive Crisis (VOC) is the most common complication of SCD, The purpose of this study is to compare patient centered outcomes for patients being treated for an uncomplicated VOC in Infusion Centers (IC) and Emergency Departments (ED) in four locations around the United States.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
483

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 17, 2019

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

3.2 years

First QC Date

March 30, 2015

Results QC Date

January 22, 2019

Last Update Submit

June 14, 2019

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

  • Time (Minutes) From Arrival to Center to Time First Dose of Parenteral Pain Medication Administered

    Time is recorded from the time the patient arrives for pain treatment at either the ED or IC until the time the patient is dosed with pain medication administered parenterally. Guideline recommendations are that patients receive non-oral pain medication within 60 minutes of arrival.

    Within 6 hours after arrival

Secondary Outcomes (4)

  • Disposition From Acute Care Visit

    Day 1 of admission

  • Pain Reassessment Within 30 Minutes of First Dose of Parenteral Pain Medication Administered

    30 minutes after administration

  • Patient Reported Satisfaction With Care Received

    within 72 hours of acute visit

  • Patient Reported Perception of Risk From Visit

    within 72 hours of acute visit

Study Arms (1)

Patients With SCD

Patients treated for uncomplicated VOC in ICs and EDs.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult subjects with SCD inclusive of genotypes homozygous and compound heterozygous sickle hemoglobin. In the United States, SCD primarily afflicts African-American and Hispanic-American populations. Patients will be enrolled prior to a vaso-occlusive crisis and data will be collected from patients' acute visit(s) at either the Emergency Department or at an Infusion center (4 participating sites).

You may qualify if:

  • Confirmed Sickle Cell Disease patients who live within 60 miles of the study center or who already receive regular care at the participating centers.

You may not qualify if:

  • Stable patients who have been on chronic transfusion therapy and have not had a painful episode within two years of enrollment.
  • Patients who are pregnant.
  • Patients who are unwilling or unable to sign consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Our Lady of the Lake Hospital

Baton Rouge, Louisiana, 70809, United States

Location

Cleveland Medical Center at University Hospitals

Cleveland, Ohio, 44106, United States

Location

Medical College of Wisconsin, Blood Center

Milwaukee, Wisconsin, 53201, United States

Location

Related Publications (8)

  • Hassell KL. Population estimates of sickle cell disease in the U.S. Am J Prev Med. 2010 Apr;38(4 Suppl):S512-21. doi: 10.1016/j.amepre.2009.12.022.

    PMID: 20331952BACKGROUND

  • Platt OS, Brambilla DJ, Rosse WF, Milner PF, Castro O, Steinberg MH, Klug PP. Mortality in sickle cell disease. Life expectancy and risk factors for early death. N Engl J Med. 1994 Jun 9;330(23):1639-44. doi: 10.1056/NEJM199406093302303.

    PMID: 7993409BACKGROUND

  • McClish DK, Penberthy LT, Bovbjerg VE, Roberts JD, Aisiku IP, Levenson JL, Roseff SD, Smith WR. Health related quality of life in sickle cell patients: the PiSCES project. Health Qual Life Outcomes. 2005 Aug 29;3:50. doi: 10.1186/1477-7525-3-50.

    PMID: 16129027BACKGROUND

  • Bediako SM. Predictors of employment status among African Americans with sickle cell disease. J Health Care Poor Underserved. 2010 Nov;21(4):1124-37. doi: 10.1353/hpu.2010.0945.

    PMID: 21099066BACKGROUND

  • Lanzkron S, Carroll CP, Hill P, David M, Paul N, Haywood C Jr. Impact of a dedicated infusion clinic for acute management of adults with sickle cell pain crisis. Am J Hematol. 2015 May;90(5):376-80. doi: 10.1002/ajh.23961. Epub 2015 Feb 25.

    PMID: 25639822BACKGROUND

  • Haywood C Jr, Tanabe P, Naik R, Beach MC, Lanzkron S. The impact of race and disease on sickle cell patient wait times in the emergency department. Am J Emerg Med. 2013 Apr;31(4):651-6. doi: 10.1016/j.ajem.2012.11.005. Epub 2013 Feb 4.

    PMID: 23380119BACKGROUND

  • Lanzkron S, Carroll CP, Haywood C Jr. The burden of emergency department use for sickle-cell disease: an analysis of the national emergency department sample database. Am J Hematol. 2010 Oct;85(10):797-9. doi: 10.1002/ajh.21807.

    PMID: 20730795BACKGROUND

  • Lanzkron S, Little J, Wang H, Field JJ, Shows JR, Haywood C Jr, Saheed M, Proudford M, Robertson D, Kincaid A, Burgess L, Green C, Seufert R, Brooks J, Piehet A, Griffin B, Arnold N, Frymark S, Wallace M, Abu Al Hamayel N, Huang CY, Segal JB, Varadhan R. Treatment of Acute Pain in Adults With Sickle Cell Disease in an Infusion Center Versus the Emergency Department : A Multicenter Prospective Cohort Study. Ann Intern Med. 2021 Sep;174(9):1207-1213. doi: 10.7326/M20-7171. Epub 2021 Jul 6.

    PMID: 34224261DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

Title
Sophie Lanzkron, MD, MHS, Associate Professor of Medicine and Oncology
Organization
Johns Hopkins University School of Medicine
slanzkr@jhmi.edu
410-502-8642

Study Officials

  • Sophie Lanzkron, MD, MHS

    Johns Hopkins University, Division of Hematology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 8, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 27, 2019

Results First Posted

June 17, 2019

Record last verified: 2019-06

Locations

US(3)