ThrombocytopeniaNCT00759980
Transfusing Neonates Based on Platelet Mass
An observational study of Thrombocytopenia, run by Christiana Care Health Services at 4 sites in United States.
Trial summary
Thrombocytopenia (low platelet count) is common in the neonatal intensive care unit. Commonly, the decision of when to transfuse platelets is based on platelet number. Recently, Christensen et al (2006) proposed using transfusion guidelines based on platelet mass rather than platelet number. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Thrombocytopenia
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2008to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants who are thrombocytopenic and hospitalized in the NICU
Who may be able to join
- Thrombocytopenic infants
Who cannot join
- Major congenital anomalies
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Christiana Care Health System
Newark, Delaware, 19711
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
A.I. duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
Official title: Transfusing Neonates Based on Platelet Mass in the Neonatal Intensive Care Unit: A Randomized Pilot Study
Thrombocytopenia (low platelet count) is common in the neonatal intensive care unit. Commonly, the decision of when to transfuse platelets is based on platelet number. Recently, Christensen et al (2006) proposed using transfusion guidelines based on platelet mass rather than platelet number. By using platelet size as a guide of when to give platelets, we may be able to decrease the amount platelet transfusions needed.
This study is investigating using platelet size rather than platelet number as a guideline for transfusing platelets in infants who are hospitalized in a NICU (neonatal intensive care unit). After obtaining parental informed consent, thrombocytopenic infants will be randomized to one of two groups. 1: Transfusion based on platelet number; 2: transfusion based on a combination of platelet number and platelet mass. In each group the decision to transfuse platelets will be made using a slightly different, yet strict set of transfusion rules.
Read more
The objective is to determine the feasibility, rate of bleeding complications and compliance of transfusing neonates based on platelet mass rather than platelet number.
The investigators hypothesize that transfusing platelets based on platelet mass will not increase bleeding complications and will reduce the number of transfusions in thrombocytopenic neonates.
- Conditions
- Thrombocytopenia
- Keywords
- Thrombocytopenia, Platelet transfusion
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Number | Infants randomized to this group will be transfused based on a specific set of transfusion guidelines pertaining to the total number of platelets | |
| Platelet Mass | Infants randomized to this group will be transfused based on a specific set of transfusion guidelines pertaining to a combination of platelet number and platelet size (mass) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of transfusions
Measured: During NICU hospitalization
Secondary outcomes (2)
Bleeding outcomes
Measured: While the infant is thrombocytopenic
Compliance with transfusion guidelines
Measured: During NICU hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Alfred I. duPont Hospital for Children, Thomas Jefferson University, Abington Memorial Hospital
- Investigators
- Jody L Zisk, DO, Principal investigator, Christiana Care Health ServicesDavid A Paul, MD, Principal investigator, Christiana Care Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759980
- Sponsor's protocol ID
- 28156
- Status last verified
- Mar 2011
- First submitted
- 24 Sep 2008
- Last updated
- 23 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusing Neonates Based on Platelet Mass in the Neonatal Intensive Care Unit: A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT00759980
- Acronym / sponsor ID
- 28156
- Conditions
- Thrombocytopenia
- Keywords
- Thrombocytopenia, Platelet transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- Alfred I. duPont Hospital for Children, Thomas Jefferson University, Abington Memorial Hospital
- Study start
- Oct 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thrombocytopenia (low platelet count) is common in the neonatal intensive care unit. Commonly, the decision of when to transfuse platelets is based on platelet number. Recently, Christensen et al (2006) proposed using transfusion guidelines based on platelet mass rather than platelet number. By using platelet size as a guide of when to give platelets, we may be able to decrease the amount platelet transfusions needed.
This study is investigating using platelet size rather than platelet number as a guideline for transfusing platelets in infants who are hospitalized in a NICU (neonatal intensive care unit). After obtaining parental informed consent, thrombocytopenic infants will be randomized to one of two groups. 1: Transfusion based on platelet number; 2: transfusion based on a combination of platelet number and platelet mass. In each group the decision to transfuse platelets will be made using a slightly different, yet strict set of transfusion rules.
The objective is to determine the feasibility, rate of bleeding complications and compliance of transfusing neonates based on platelet mass rather than platelet number.
The investigators hypothesize that transfusing platelets based on platelet mass will not increase bleeding complications and will reduce the number of transfusions in thrombocytopenic neonates.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Number | – | –Infants randomized to this group will be transfused based on a specific set of transfusion guidelines pertaining to the total number of platelets |
| Platelet Mass | – | –Infants randomized to this group will be transfused based on a specific set of transfusion guidelines pertaining to a combination of platelet number and platelet size (mass) |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants who are thrombocytopenic and hospitalized in the NICU
Key inclusion criteria (1 listed)
- Thrombocytopenic infants
Key exclusion criteria (1 listed)
- Major congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total number of transfusions
Time frame: During NICU hospitalization
2 secondary outcomes
Bleeding outcomes
Time frame: While the infant is thrombocytopenic
Compliance with transfusion guidelines
Time frame: During NICU hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2011.
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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.
Jody L Zisk, DO principal investigator
Christiana Care Health Services
David A Paul, MD principal investigator
Christiana Care Health Systems
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia, run by Christiana Care Health Services at 4 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total number of transfusions (time frame: During NICU hospitalization). 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 23 Mar 2011.