Acute Chest SyndromePhase 2NCT02098993
Feasibility Study of Unfractionated Heparin in Acute Chest Syndrome
A Phase 2 study testing Unfractionated heparin in people with Acute Chest Syndrome and Sickle Cell Disease, run by Craig Seaman at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Chest Syndrome, Sickle Cell Disease
- What is being tested?
- Unfractionated heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 27 Jun 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
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
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.
- Conditions
- Acute Chest Syndrome, Sickle Cell Disease
- Being tested
- Unfractionated heparin
- Keywords
- Sickle cell disease, Acute chest syndrome, Hemoglobinopathy, Hemolytic anemia, Heparin, Anticoagulant
- Medical subject headings
- Acute Chest Syndrome, Anemia, Sickle Cell, Hemoglobinopathies, Anemia, Hemolytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unfractionated heparinDrug
| Study group | Role | What they receive |
|---|---|---|
| Unfractionated heparin | Experimental | 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. Receives: Drug: Unfractionated heparin |
| Standard of care | No intervention | Standard care will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Hospital Discharge
Duration of hospitalization
Measured: Until hospital discharge
Secondary outcomes (9)
Duration of Hypoxemia Assessed by Arterial Oxygen Saturation
Arterial oxygen saturation less than 90%
Measured: 7 days
Duration of Fever Assessed by Body Temperature
Body temperature greater than or equal to 38.0 degrees Celsius
Measured: 7 days
Duration of Leukocytosis Assessed by White Blood Cell Count
White blood cell count greater than 10,000 per liter
Measured: 7 days
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
Measured: 7 days
Opioid Administration Per Participant
Total dose of opioids per participant
Measured: 7 days
Units of Red Blood Cells Administered
Total number of units of red blood cells
Measured: 7 days
Percentage of Participants Transferred to Intensive Care Unit
Measured: 7 days
Percentage of Participants Requiring Mechanical Ventilation
Measured: 7 days
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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startMay 2014
- Primary completion27 Jun 2018
- Study completion27 Jun 2018
Why it stopped: Poor enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Chest SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Seaman
- Sponsor type
- University, hospital or other
- Collaborators
- Vascular Medicine Institute
- Responsible party
- Sponsor-investigator, Craig Seaman, University of Pittsburgh
- Investigators
- Craig D Seaman, MD, Principal investigator, University of PittsburghMargaret Ragni, MD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098993
- Sponsor's protocol ID
- ACS13090197
- Status last verified
- Jun 2019
- First submitted
- 25 Mar 2014
- Last updated
- 16 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02098993
- Acronym / sponsor ID
- ACS13090197
- Conditions
- Acute Chest Syndrome, Sickle Cell Disease
- Keywords
- Sickle cell disease, Acute chest syndrome, Hemoglobinopathy, Hemolytic anemia, Heparin, Anticoagulant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Craig SeamanUniversity, hospital or other
- Collaborators
- Vascular Medicine Institute
- Study start
- May 2014
- Primary completion
- 27 Jun 2018 (actual)
- Study completion
- 27 Jun 2018 (actual)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Posted 16 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unfractionated heparin | Experimental | Drug: Unfractionated heparinSubjects 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 of care | No intervention | –Standard care will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unfractionated heparin | Drug | Unfractionated heparin |
Primary outcome
Time to Hospital Discharge
Time frame: Until hospital discharge
Duration of hospitalization
9 secondary outcomes
Duration of Hypoxemia Assessed by Arterial Oxygen Saturation
Time frame: 7 days
Duration of Fever Assessed by Body Temperature
Time frame: 7 days
Duration of Leukocytosis Assessed by White Blood Cell Count
Time frame: 7 days
Duration of Moderate to Severe Pain Assessed by Visual Analog Scale for Pain
Time frame: 7 days
Opioid Administration Per Participant
Time frame: 7 days
Units of Red Blood Cells Administered
Time frame: 7 days
Percentage of Participants Transferred to Intensive Care Unit
Time frame: 7 days
Percentage of Participants Requiring Mechanical Ventilation
Time frame: 7 days
Percentage of Participants Experiencing Multiorgan Dysfunction Syndrome
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig D Seaman, MD principal investigator
University of Pittsburgh
Margaret Ragni, MD, MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Unfractionated heparin in people with Acute Chest Syndrome and Sickle Cell Disease, run by Craig Seaman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Hospital Discharge (time frame: Until hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.