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Feasibility Study of Unfractionated Heparin in Acute Chest Syndrome

Primary Purpose

Acute Chest Syndrome, Sickle Cell Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Unfractionated heparin
Sponsored by
Craig Seaman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Chest Syndrome focused on measuring Sickle cell disease, Acute chest syndrome, Hemoglobinopathy, Hemolytic anemia, Heparin, Anticoagulant

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of ACS defined as a new pulmonary infiltrate involving at least one segment of the lung on a chest x-ray or chest CT scan with 2 or more of the following: chest pain, tachypnea, dyspnea, cough, hypoxemia, or body temperature greater than or equal to 38.0 degrees Celsius
  • Hemoglobin electrophoresis confirming HbSS, SC, or B0 (historical records sufficient)
  • Age greater than or equal to 18

Exclusion Criteria:

  • Any absolute contraindication to heparin
  • Platelet count less than 50 per microliter (current admission)
  • Historical diagnosis of moyamoya disease as documented in medical records
  • Historical diagnosis of proliferative retinopathy as documented in medical records
  • Current participation in a chronic exchange transfusion program
  • Underlying hypercoagulable disorder other than sickle cell disease
  • Currently receiving therappeutic anticoagulation
  • Currently receiving antiplatelet agents
  • Currently receiving estrogen containing oral contraceptives
  • Chest CT scan documented PE performed as standard of care prior to study enrollment (current admission)

Sites / Locations

  • University of Pittsburg Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Unfractionated heparin

Standard of care

Arm Description

Subjects will be randomized within 24 hours of diagnosis to one of two treatment arms, Arm A, anticoagulation and standard of care, or Arm B, no anticoagulation and standard of care. Weight-adjusted UFH will be given at doses of 80 units per kilogram followed by 18 units per kilogram per hour intravenously for 7 days, or until discharge, if discharge is shorter than 7 days. UFH will be monitored by standard protocol to maintain the activated partial thromboplastin time in the therapeutic range per institutional guidelines. The experimental arm will receive standard of care, too, which will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions.

Standard care will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions.

Outcomes

Primary Outcome Measures

Time to Hospital Discharge
Duration of hospitalization

Secondary Outcome Measures

Duration of Hypoxemia Assessed by Arterial Oxygen Saturation
Arterial oxygen saturation less than 90%
Duration of Fever Assessed by Body Temperature
Body temperature greater than or equal to 38.0 degrees Celsius
Duration of Leukocytosis Assessed by White Blood Cell Count
White blood cell count greater than 10,000 per liter
Duration of Moderate to Severe Pain Assessed by Visual Analog Scale for Pain
Score of 4 or greater on the Visual Analog Scale for pain
Opioid Administration Per Participant
Total dose of opioids per participant
Units of Red Blood Cells Administered
Total number of units of red blood cells
Percentage of Participants Transferred to Intensive Care Unit
Percentage of Participants Requiring Mechanical Ventilation
Percentage of Participants Experiencing Multiorgan Dysfunction Syndrome
Acute development of 2 or more organs or organ systems unable to maintain homeostasis in a critically ill individual

Full Information

First Posted
March 25, 2014
Last Updated
June 25, 2019
Sponsor
Craig Seaman
Collaborators
Vascular Medicine Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02098993
Brief Title
Feasibility Study of Unfractionated Heparin in Acute Chest Syndrome
Official Title
Unfractionated Heparin in Acute Chest Syndrome: A Pilot Feasibility Randomized Controlled Trial of Unfractionated Heparin vs. Standard of Care in Acute Chest Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment.
Study Start Date
May 2014 (undefined)
Primary Completion Date
June 27, 2018 (Actual)
Study Completion Date
June 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Craig Seaman
Collaborators
Vascular Medicine Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the feasibility of performing a larger multicenter phase III trial to assess the effects of unfractionated heparin (UFH) in acute chest syndrome (ACS). Prespecified feasibility criteria consists of the ability to enroll potential study participants, which includes the timely notification of hospitalized patients with ACS, the capacity to consent eligible individuals, and the ability to appropriately randomize eligible patients within 24 hours of diagnosis. Additional feasibility objectives involve ensuring appropriate eligibility criteria, proper administration of the study drug, and the ability to completely and accurately collect clinical data of interest. The final aim of our pilot study is to provide preliminary data, with respect to treatment effect and variance, to allow sample size calculation in a larger trial given the lack of data available to help guide this process. The investigators hypothesize that the use of UFH in ACS will result in a decrease in the duration of hospitalization and improve other clinical outcomes, such as the duration of hypoxemia and duration of moderate to severe pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Chest Syndrome, Sickle Cell Disease
Keywords
Sickle cell disease, Acute chest syndrome, Hemoglobinopathy, Hemolytic anemia, Heparin, Anticoagulant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unfractionated heparin
Arm Type
Experimental
Arm Description
Subjects will be randomized within 24 hours of diagnosis to one of two treatment arms, Arm A, anticoagulation and standard of care, or Arm B, no anticoagulation and standard of care. Weight-adjusted UFH will be given at doses of 80 units per kilogram followed by 18 units per kilogram per hour intravenously for 7 days, or until discharge, if discharge is shorter than 7 days. UFH will be monitored by standard protocol to maintain the activated partial thromboplastin time in the therapeutic range per institutional guidelines. The experimental arm will receive standard of care, too, which will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Standard care will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions.
Intervention Type
Drug
Intervention Name(s)
Unfractionated heparin
Primary Outcome Measure Information:
Title
Time to Hospital Discharge
Description
Duration of hospitalization
Time Frame
Until hospital discharge
Secondary Outcome Measure Information:
Title
Duration of Hypoxemia Assessed by Arterial Oxygen Saturation
Description
Arterial oxygen saturation less than 90%
Time Frame
7 days
Title
Duration of Fever Assessed by Body Temperature
Description
Body temperature greater than or equal to 38.0 degrees Celsius
Time Frame
7 days
Title
Duration of Leukocytosis Assessed by White Blood Cell Count
Description
White blood cell count greater than 10,000 per liter
Time Frame
7 days
Title
Duration of Moderate to Severe Pain Assessed by Visual Analog Scale for Pain
Description
Score of 4 or greater on the Visual Analog Scale for pain
Time Frame
7 days
Title
Opioid Administration Per Participant
Description
Total dose of opioids per participant
Time Frame
7 days
Title
Units of Red Blood Cells Administered
Description
Total number of units of red blood cells
Time Frame
7 days
Title
Percentage of Participants Transferred to Intensive Care Unit
Time Frame
7 days
Title
Percentage of Participants Requiring Mechanical Ventilation
Time Frame
7 days
Title
Percentage of Participants Experiencing Multiorgan Dysfunction Syndrome
Description
Acute development of 2 or more organs or organ systems unable to maintain homeostasis in a critically ill individual
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of ACS defined as a new pulmonary infiltrate involving at least one segment of the lung on a chest x-ray or chest CT scan with 2 or more of the following: chest pain, tachypnea, dyspnea, cough, hypoxemia, or body temperature greater than or equal to 38.0 degrees Celsius Hemoglobin electrophoresis confirming HbSS, SC, or B0 (historical records sufficient) Age greater than or equal to 18 Exclusion Criteria: Any absolute contraindication to heparin Platelet count less than 50 per microliter (current admission) Historical diagnosis of moyamoya disease as documented in medical records Historical diagnosis of proliferative retinopathy as documented in medical records Current participation in a chronic exchange transfusion program Underlying hypercoagulable disorder other than sickle cell disease Currently receiving therappeutic anticoagulation Currently receiving antiplatelet agents Currently receiving estrogen containing oral contraceptives Chest CT scan documented PE performed as standard of care prior to study enrollment (current admission)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig D Seaman, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margaret Ragni, MD, MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburg Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility Study of Unfractionated Heparin in Acute Chest Syndrome

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