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Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease (COMPARE-VOE)

Primary Purpose

Sickle Cell Disease

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Patient-Specific Protocol
Weight-based Protocol
Morphine
Hydromorphone
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All adult (18 years or older);
  • SCD patients with the following genotypes: Hgb SS, SC, and SB+ and SB- thalassemia

Exclusion Criteria:

  • determined to not benefit from opioids and therefore won't receive opioids in any future ED visit.

Sites / Locations

  • University of Maryland
  • Henry Ford Health System
  • Wayne State University
  • Atrium Health
  • Case Western University
  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patient-Specific Protocol

Weight-based Protocol

Arm Description

Patients assigned to this treatment protocol will be given pain medicine(s) based on the pain medicine(s) they take at home, what was needed during their past hospital and emergency department visits to treat pain and doses that have been effective and safe in the past.

Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight.

Outcomes

Primary Outcome Measures

The Change in Pain Score
Pain is measured by having the patient mark pain on a scale of 0 to 100, with 0 being no pain and 100 being the worst pain ever. Pain scores were initially measured using a 0-100 millimeter visual analog scale with higher (closer to 100 being worse); however during the COVID-19 pandemic, one site removed paper forms from the emergency department as an infection control measure. The protocol was amended to add collection of a 0-100 verbal numerical rating scale and sites were ask to obtain both a vision and verbal score if possible collecting the visual score first. For the analysis, the visual score was used if available for the primary outcome. if not available, the verbal score was used.

Secondary Outcome Measures

Length of Index ED (Emergency Department) Stay
Length of index ED stay in hours from bed placement to discharge
Length of Care
Length of care from bed placement to last drug dose in hours.
Total Number of Hospitalizations for Vaso-Occlusive Episode 7 Days Post Enrollment
Number of hospitalizations for Vaso-Occlusive Episode (VOE) within 7 days following enrollment
Number of Participants Experiencing Side Effects
Side effects and safety at any time during the emergency department visit

Full Information

First Posted
April 29, 2019
Last Updated
June 13, 2023
Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03933397
Brief Title
Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease
Acronym
COMPARE-VOE
Official Title
A Comparison of Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to COVID enrollment numbers needed to meet the primary endpoint will not be met.
Study Start Date
August 13, 2019 (Actual)
Primary Completion Date
May 13, 2022 (Actual)
Study Completion Date
May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this research study is to compare two different ways to give opioid pain medicine to treat sickle cell disease pain that is bad enough to go to the emergency department for treatment. One way uses your weight to decide how much pain medicine to give you while in the emergency department. This is called weight based treatment. The other way uses how much pain medicine you take at home and how much medicine you needed during past emergency department visits to decide how much medicine to give you. This is called patient specific treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
328 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient-Specific Protocol
Arm Type
Experimental
Arm Description
Patients assigned to this treatment protocol will be given pain medicine(s) based on the pain medicine(s) they take at home, what was needed during their past hospital and emergency department visits to treat pain and doses that have been effective and safe in the past.
Arm Title
Weight-based Protocol
Arm Type
Experimental
Arm Description
Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight.
Intervention Type
Other
Intervention Name(s)
Patient-Specific Protocol
Intervention Description
Patients assigned to this treatment protocol will be given pain medicine(s) based on the pain medicine(s) they take at home for pain and what was needed during their past hospital and emergency department visits to treat pain. Medicines will include opioids, either morphine or hydromorphone. A member of the outpatient SCD provider team will review the patient's medical record to determine: 1) the patient's maximum home opioid dose, and 2) previous ED analgesic medication(s) and doses that have been effective and safe in the past. The patient's regular hematologist/sickle cell team will write the treatment plans. Medications will be given every 20-30 minutes for up to 6 hours.
Intervention Type
Other
Intervention Name(s)
Weight-based Protocol
Intervention Description
Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Medicines will include opioids, either morphine or hydromorphone. Plans will be written by the patients regular hematologist/sickle cell team.
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Morphine Sulfate
Intervention Description
4 mg for participants weighing <50 kgs, 6mg for participants weighing 50-69.9 kgs, 8mg for participants weighing 70 - 89.9 kgs and 10mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%.
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Other Intervention Name(s)
Dilaudid
Intervention Description
1 mg for participants weighing <60 kgs, 1.5 mg for participants weighing 60 - 89.9 kgs, and 2 mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%.
Primary Outcome Measure Information:
Title
The Change in Pain Score
Description
Pain is measured by having the patient mark pain on a scale of 0 to 100, with 0 being no pain and 100 being the worst pain ever. Pain scores were initially measured using a 0-100 millimeter visual analog scale with higher (closer to 100 being worse); however during the COVID-19 pandemic, one site removed paper forms from the emergency department as an infection control measure. The protocol was amended to add collection of a 0-100 verbal numerical rating scale and sites were ask to obtain both a vision and verbal score if possible collecting the visual score first. For the analysis, the visual score was used if available for the primary outcome. if not available, the verbal score was used.
Time Frame
baseline (bed placement), to disposition decision or a maximum treatment duration of 6 hours, whichever came first
Secondary Outcome Measure Information:
Title
Length of Index ED (Emergency Department) Stay
Description
Length of index ED stay in hours from bed placement to discharge
Time Frame
From bed placement to discharge or 6 hours whichever comes first
Title
Length of Care
Description
Length of care from bed placement to last drug dose in hours.
Time Frame
up to 6 hours
Title
Total Number of Hospitalizations for Vaso-Occlusive Episode 7 Days Post Enrollment
Description
Number of hospitalizations for Vaso-Occlusive Episode (VOE) within 7 days following enrollment
Time Frame
Up to 7 days post enrollment
Title
Number of Participants Experiencing Side Effects
Description
Side effects and safety at any time during the emergency department visit
Time Frame
Bed placement to discharge or 6 hours, whichever comes first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All adult (18 years or older); Sickle Cell Disease patients with the following genotypes: Hgb SS (sickle cell anemia), SC(Sickle hemoglobin-c) , and SB+(sickle Beta-Plus thalassemia) and SB-(sickle Beta zero thalassemia) Exclusion Criteria: determined to not benefit from opioids and therefore won't receive opioids in any future Emergency Department visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huiman Barnhart, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paula Tanabe, PhD
Organizational Affiliation
Duke University School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Atrium Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Case Western University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease

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