ThrombocytopeniaPhase 3TESSINCT00261924
Efficacy and Safety Study of Platelets Treated for Pathogen Inactivation and Stored for Up to Seven Days
A Phase 3 study testing Transfusion of Pathogen Inactivated Platelets stored for 6-7 days in people with Thrombocytopenia, run by Cerus Corporation at 1 site in United Kingdom.
Trial summary
Objective: To determine if platelets treated for pathogen inactivation and stored for 6 to 7 days are safe and effective compared to platelets collected by the same method, stored for the same amount of time and not treated for pathogen inactivation. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- Transfusion of Pathogen Inactivated Platelets stored for 6-7 days
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2005to Jul 2009
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- At least 16 years old
- Written informed consent
- Thrombocytopenia, or expected to develop thrombocytopenia requiring platelet transfusion within 15 days of randomization
- Undergoing one haematopoietic stem cell transplantation and/or admitted for treatment of acute or chronic leukaemia, lymphoma, multiple myeloma or myelodysplasia
Who cannot join
- Refractoriness to platelet transfusion
- Immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura, or hemolytic uremic syndrome
- Use of IL-11 (Neumega®) or other investigational platelet growth factor
- Disseminated intravascular coagulation (DIC)
- Clinically or radiologically detectable splenomegaly
- Previous participation in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
SNBTS National Science Laboratory, Edinburgh and Western General Hospital
Edinburgh
About this study
Official title: Clinical Trial to Evaluate the Therapeutic Efficacy and Safety of INTERCEPT Platelets Stored for up to Seven Days After Collection
Objective: To determine if platelets treated for pathogen inactivation and stored for 6 to 7 days are safe and effective compared to platelets collected by the same method, stored for the same amount of time and not treated for pathogen inactivation.
Read the detailed description
Although the European Commission directive 2004/33/EC states that platelet preparations may be stored for 7 days in conjunction with detection or reduction of bacterial contamination, most blood centers store platelets for only 4 or 5 days. Extending the storage time could greatly improve platelet availability for patients while decreasing wastage of this limited resource.
- Conditions
- Thrombocytopenia
- Being tested
- Transfusion of Pathogen Inactivated Platelets stored for 6-7 days
- Keywords
- Thrombocytopenic patients
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfusion of Pathogen Inactivated Platelets stored for 6-7 daysDevice
Also called INTERCEPT
pathogen inactivation of platelets for transfusion
| Study group | Role | What they receive |
|---|---|---|
| Intercept Platelets | Experimental | Study patients receiving platelets that have been processed with the INTERCEPT pathogen inactivation system Receives: Device: Transfusion of Pathogen Inactivated Platelets stored for 6-7 days |
| Conventional Platelets | Active comparator | Study patients receiving platelets processed by standard method without the INTERCEPT pathogen inactivation system Receives: Device: Transfusion of Pathogen Inactivated Platelets stored for 6-7 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 hour corrected count increment for platelets
1-h CCI
Measured: One hour after platelet transfusion
Secondary outcomes (1)
Transfusion related adverse events
Measured: 24 hours after transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2005 (estimated)
- Study startOct 2005
- Primary completionJul 2009
- Study completionJul 2009
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerus Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Larry Corash, M.D., Study director, Cerus Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261924
- Sponsor's protocol ID
- 451-P-A-NIV
- Acronym
- TESSI
- Status last verified
- Dec 2005
- First submitted
- 5 Dec 2005
- Last updated
- 14 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Therapeutic Efficacy and Safety of INTERCEPT Platelets Stored for up to Seven Days After Collection
- ClinicalTrials.gov ID
- NCT00261924
- Acronym / sponsor ID
- TESSI / 451-P-A-NIV
- Conditions
- Thrombocytopenia
- Keywords
- Thrombocytopenic patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Cerus CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 6 Dec 2005 (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.
Objective: To determine if platelets treated for pathogen inactivation and stored for 6 to 7 days are safe and effective compared to platelets collected by the same method, stored for the same amount of time and not treated for pathogen inactivation.
Detailed description
Although the European Commission directive 2004/33/EC states that platelet preparations may be stored for 7 days in conjunction with detection or reduction of bacterial contamination, most blood centers store platelets for only 4 or 5 days. Extending the storage time could greatly improve platelet availability for patients while decreasing wastage of this limited resource.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intercept Platelets | Experimental | Device: Transfusion of Pathogen Inactivated Platelets stored for 6-7 daysStudy patients receiving platelets that have been processed with the INTERCEPT pathogen inactivation system |
| Conventional Platelets | Active comparator | Device: Transfusion of Pathogen Inactivated Platelets stored for 6-7 daysStudy patients receiving platelets processed by standard method without the INTERCEPT pathogen inactivation system |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- At least 16 years old
- Written informed consent
- Thrombocytopenia, or expected to develop thrombocytopenia requiring platelet transfusion within 15 days of randomization
- Undergoing one haematopoietic stem cell transplantation and/or admitted for treatment of acute or chronic leukaemia, lymphoma, multiple myeloma or myelodysplasia
Key exclusion criteria (6 listed)
- Refractoriness to platelet transfusion
- Immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura, or hemolytic uremic syndrome
- Use of IL-11 (Neumega®) or other investigational platelet growth factor
- Disseminated intravascular coagulation (DIC)
- Clinically or radiologically detectable splenomegaly
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 |
|---|---|---|
| Transfusion of Pathogen Inactivated Platelets stored for 6-7 daysAlso: INTERCEPTpathogen inactivation of platelets for transfusion | Device | Conventional Platelets, Intercept Platelets |
Primary outcome
1 hour corrected count increment for platelets
Time frame: One hour after platelet transfusion
1-h CCI
1 secondary outcome
Transfusion related adverse events
Time frame: 24 hours after transfusion
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 14 Apr 2010.
Related trials for Thrombocytopenia
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 3
rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
Thrombocytopenia Associated With Chronic Liver Disease
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
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.
Larry Corash, M.D. study director
Cerus Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transfusion of Pathogen Inactivated Platelets stored for 6-7 days in people with Thrombocytopenia, run by Cerus Corporation at 1 site in United Kingdom.
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 4 inclusion and 6 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 14 Apr 2010. 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 Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
1 hour corrected count increment for platelets (time frame: One hour after platelet transfusion). 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 14 Apr 2010.