Healthy VolunteersNCT02298842
In Vitro Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution
A study testing Platelets stored in InterSol and Platelets stored in Plasma in people with Healthy Volunteers, run by Terumo BCT at 2 sites in United States.
Trial summary
This study sought to verify that the in vitro quality (functional assays) of platelets collected on the Trima Accel system, Version 6.4, diluted in InterSol Solution, and stored for 1, 5, and 7 days meet FDA requirements. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Platelets stored in InterSol and Platelets stored in Plasma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Nov 2015to 12 May 2016
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years of age or older
- Meet the inclusion criteria defined by the Investigational Site for an apheresis double platelet with plasma collection on the Trima Accel System. These criteria are based on American Association of Blood Banks (AABB) standards. Note: Subjects who are deferred from volunteer community donations because of travel restrictions, piercings or tattoos may participate in the study.
Who cannot join
- None.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hoxworth Blood Center
Cincinnati, Ohio, 45267
Blood Center of Wisconsin
Milwaukee, Wisconsin, 53233
About this study
This study sought to verify that the in vitro quality (functional assays) of platelets collected on the Trima Accel system, Version 6.4, diluted in InterSol Solution, and stored for 1, 5, and 7 days meet FDA requirements.
Read the detailed description
Platelets suspended in platelet additive solutions (PAS) have been collected and transfused in Europe for over 20 years. These PAS solutions outside of the United States (US) are not tied to an apheresis device; however in the US, PAS solutions have traditionally been linked to a corresponding apheresis device.
Currently in the US, there are two solutions approved by the Food and Drug Administration (FDA) as a PAS for the replacement of 65% plasma in platelet components. Isoplate Solution is approved for use with the Trima Accel® Automated Blood Collection System (Trima Accel System) and InterSol Solution is approved for use with the Amicus Separator System.
This study is designed to provide blood centers with the option to use either Isoplate or InterSol when collecting platelets for use with PAS. Terumo BCT is pursuing approval for InterSol Solution in combination with the Trima Accel System.
This is a randomized, paired, prospective, open-label, multi-center study. Up to 120 healthy adult subjects will be enrolled in this study to ensure 60 paired evaluable data points across two Investigational Sites. Evaluable is defined as two completed platelet products with 100mL plasma that do not meet any of the protocol analysis exclusion criteria.
The additional platelet donors account for screen failures, incomplete procedures, and protocol exclusions.
Two units of platelets will be collected from each subject: one Test unit collected as a hyperconcentrated platelet product with 100 mL of concurrent plasma and one Control unit of platelets in plasma collected according to standard procedure. The Test unit will be suspended in 65% Intersol/35% plasma immediately after collection; the Control unit will be maintained in 100% plasma.
Eligible donors who have signed an informed consent will be enrolled. Randomization will occur in a ratio of 1:1 to one of the following Treatment Arms:
Arm A: Collection of one Test unit followed by collection of one Control unit Arm B: Collection of one Control unit followed by collection of one Test unit
The standard apheresis platelet units collected in the Control arm will mirror the hyperconcentrated platelet units in the Test arm in terms of yield and final concentration.
SUBJECT PROCEDURES
Screening can be performed within 30 days of the apheresis procedure or combined with the first Apheresis Visit.
The following evaluations will be performed:
- Informed consent will be obtained prior to initiating any study specific procedures
- Eligibility will be confirmed
- Demographics (age, gender, ethnic origin), height, and weight
- Complete blood count (CBC) for hemoglobin and platelet count on subjects new to the Investigative Site that do not have historical hemoglobin and/or platelet count measurements
Apheresis Visit
The following procedures will be performed at both the first and second Apheresis Visits:
- Eligibility will be confirmed
- Finger stick hemoglobin
- First apheresis procedure will be performed
Subject will return to the Site in 6 to 8 days following the first apheresis collection for the second apheresis collection. This will conclude the subject's participation.
Apheresis procedures will be run according to the instructions and precautions described in the commercially available Trima Accel Operator's Manual for use with Version 6.4.
The Investigator or designee will perform the venipuncture, monitor the subject during the collection, assess and provide any interventions for adverse effects, remove the needle, dress the puncture site and monitor subject through recovery.
The following will be documented:
- Trima Procedure details
- Adverse events
- Medications to treat AEs
- Device deficiencies
- Conditions
- Healthy Volunteers
- Being tested
- Platelets stored in InterSol, Platelets stored in Plasma
- Keywords
- Healthy Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelets stored in InterSolDevice
A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
Platelets stored in PlasmaDevice
A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
| Study group | Role | What they receive |
|---|---|---|
| Platelets Stored in Plasma | Active comparator | Platelets stored in Plasma Receives: Device: Platelets stored in Plasma |
| Test Platelets Stored in InterSol | Experimental | Platelets stored in InterSol Receives: Device: Platelets stored in InterSol |
What is being measured
The primary outcome is the main question the study is designed to answer.
pH of Platelets at Day 5
The primary endpoint for this study is pH of platelets stored in InterSol at Day 5. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.
Measured: Day 5
pH of Platelets at Day 7
The primary endpoint for this study is pH of platelets stored in InterSol at Day 7. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.
Measured: Day 7
Secondary outcomes (8)
Percent of Platelets Activated as Measured by P-selectin
Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality.
Measured: Day 5
Percent of Extent of Shape Change
Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality.
Measured: Day 5
Percent of Platelets Exhibiting Hypotonic Shock Response
Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality.
Measured: Day 5
Platelet Morphology
Quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher values represent healthier platelets.
Measured: Day 5
Percent of Platelets Activated as Measured by P-selectin
Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality.
Measured: Day 7
Percent of Extent of Shape Change
Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality. Higher value is considered to indicate better platelet quality.
Measured: Day 7
Percent of Platelets Exhibiting Hypotonic Shock Response
Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality.
Measured: Day 7
Platelet Morphology
Quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher values represent healthier platelets.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study start5 Nov 2015
- Primary completion12 May 2016
- Study completion12 May 2016
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.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo BCT
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Cancelas-Perez, MD, PhD, Principal investigator, Hoxworth Blood CenterMehraboon S Irani, MD, Principal investigator, Clood Center of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298842
- Sponsor's protocol ID
- CTS-5051
- Status last verified
- Jul 2017
- First submitted
- 14 Nov 2014
- Last updated
- 21 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Dumont LJ, Cancelas JA, Graminske S, Friedman KD, Vassallo RR, Whitley PH, Rugg N, Dumont DF, Herschel L, Siegal AH, Szczepiorkowski ZM, Fender L, Razatos A. In vitro and in vivo quality of leukoreduced apheresis platelets stored in a new platelet additive solution. Transfusion. 2013 May;53(5):972-80. doi: 10.1111/j.1537-2995.2012.03841.x. Epub 2012 Aug 6.
PubMed 22882530Ringwald J, Walz S, Zimmermann R, Zingsem J, Strasser E, Weisbach V, Eckstein R. Hyperconcentrated platelets stored in additive solution: aspects on productivity and in vitro quality. Vox Sang. 2005 Jul;89(1):11-8. doi: 10.1111/j.1423-0410.2005.00645.x.
PubMed 15938735Cohn CS, Stubbs J, Schwartz J, Francis R, Goss C, Cushing M, Shaz B, Mair D, Brantigan B, Heaton WA. A comparison of adverse reaction rates for PAS C versus plasma platelet units. Transfusion. 2014 Aug;54(8):1927-34. doi: 10.1111/trf.12597. Epub 2014 Apr 16.
PubMed 24735171Diedrich B, Sandgren P, Jansson B, Gulliksson H, Svensson L, Shanwell A. In vitro and in vivo effects of potassium and magnesium on storage up to 7 days of apheresis platelet concentrates in platelet additive solution. Vox Sang. 2008 Feb;94(2):96-102. doi: 10.1111/j.1423-0410.2007.01002.x. Epub 2007 Nov 22.
PubMed 18034788Gulliksson H, AuBuchon JP, Vesterinen M, Sandgren P, Larsson S, Pickard CA, Herschel I, Roger J, Tracy JE, Langweiler M; Biomedical Excellence for Safer Transfusion Working Party of the International Society of Blood Transfusion. Storage of platelets in additive solutions: a pilot in vitro study of the effects of potassium and magnesium. Vox Sang. 2002 Apr;82(3):131-6. doi: 10.1046/j.1423-0410.2002.drfgv158.x.
PubMed 11952987Dumont LJ, VandenBroeke T, Ault KA. Platelet surface P-selectin measurements in platelet preparations: an international collaborative study. Biomedical Excellence for Safer Transfusion (BEST) Working Party of the International Society of Blood Transfusion (ISBT). Transfus Med Rev. 1999 Jan;13(1):31-42. doi: 10.1016/s0887-7963(99)80086-8. No abstract available.
PubMed 9924762
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution
- ClinicalTrials.gov ID
- NCT02298842
- Acronym / sponsor ID
- CTS-5051
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Terumo BCTIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2015
- Primary completion
- 12 May 2016 (actual)
- Study completion
- 12 May 2016 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Posted 14 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study sought to verify that the in vitro quality (functional assays) of platelets collected on the Trima Accel system, Version 6.4, diluted in InterSol Solution, and stored for 1, 5, and 7 days meet FDA requirements.
Detailed description
Platelets suspended in platelet additive solutions (PAS) have been collected and transfused in Europe for over 20 years. These PAS solutions outside of the United States (US) are not tied to an apheresis device; however in the US, PAS solutions have traditionally been linked to a corresponding apheresis device.
Currently in the US, there are two solutions approved by the Food and Drug Administration (FDA) as a PAS for the replacement of 65% plasma in platelet components. Isoplate Solution is approved for use with the Trima Accel® Automated Blood Collection System (Trima Accel System) and InterSol Solution is approved for use with the Amicus Separator System.
This study is designed to provide blood centers with the option to use either Isoplate or InterSol when collecting platelets for use with PAS. Terumo BCT is pursuing approval for InterSol Solution in combination with the Trima Accel System.
This is a randomized, paired, prospective, open-label, multi-center study. Up to 120 healthy adult subjects will be enrolled in this study to ensure 60 paired evaluable data points across two Investigational Sites. Evaluable is defined as two completed platelet products with 100mL plasma that do not meet any of the protocol analysis exclusion criteria.
The additional platelet donors account for screen failures, incomplete procedures, and protocol exclusions.
Two units of platelets will be collected from each subject: one Test unit collected as a hyperconcentrated platelet product with 100 mL of concurrent plasma and one Control unit of platelets in plasma collected according to standard procedure. The Test unit will be suspended in 65% Intersol/35% plasma immediately after collection; the Control unit will be maintained in 100% plasma.
Eligible donors who have signed an informed consent will be enrolled. Randomization will occur in a ratio of 1:1 to one of the following Treatment Arms:
Arm A: Collection of one Test unit followed by collection of one Control unit Arm B: Collection of one Control unit followed by collection of one Test unit
The standard apheresis platelet units collected in the Control arm will mirror the hyperconcentrated platelet units in the Test arm in terms of yield and final concentration.
SUBJECT PROCEDURES
Screening can be performed within 30 days of the apheresis procedure or combined with the first Apheresis Visit.
The following evaluations will be performed:
- Informed consent will be obtained prior to initiating any study specific procedures
- Eligibility will be confirmed
- Demographics (age, gender, ethnic origin), height, and weight
- Complete blood count (CBC) for hemoglobin and platelet count on subjects new to the Investigative Site that do not have historical hemoglobin and/or platelet count measurements
Apheresis Visit
The following procedures will be performed at both the first and second Apheresis Visits:
- Eligibility will be confirmed
- Finger stick hemoglobin
- First apheresis procedure will be performed
Subject will return to the Site in 6 to 8 days following the first apheresis collection for the second apheresis collection. This will conclude the subject's participation.
Apheresis procedures will be run according to the instructions and precautions described in the commercially available Trima Accel Operator's Manual for use with Version 6.4.
The Investigator or designee will perform the venipuncture, monitor the subject during the collection, assess and provide any interventions for adverse effects, remove the needle, dress the puncture site and monitor subject through recovery.
The following will be documented:
- Trima Procedure details
- Adverse events
- Medications to treat AEs
- Device deficiencies
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelets Stored in Plasma | Active comparator | Device: Platelets stored in PlasmaPlatelets stored in Plasma |
| Test Platelets Stored in InterSol | Experimental | Device: Platelets stored in InterSolPlatelets stored in InterSol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years of age or older
- Meet the inclusion criteria defined by the Investigational Site for an apheresis double platelet with plasma collection on the Trima Accel System. These criteria are based on American Association of Blood Banks (AABB) standards. Note: Subjects who are deferred from volunteer community donations because of travel restrictions, piercings or tattoos may participate in the study.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Platelets stored in InterSolA platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other. | Device | Test Platelets Stored in InterSol |
| Platelets stored in PlasmaA platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other. | Device | Platelets Stored in Plasma |
Primary outcome
pH of Platelets at Day 5
Time frame: Day 5
The primary endpoint for this study is pH of platelets stored in InterSol at Day 5. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.
pH of Platelets at Day 7
Time frame: Day 7
The primary endpoint for this study is pH of platelets stored in InterSol at Day 7. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.
8 secondary outcomes
Percent of Platelets Activated as Measured by P-selectin
Time frame: Day 5
Percent of Extent of Shape Change
Time frame: Day 5
Percent of Platelets Exhibiting Hypotonic Shock Response
Time frame: Day 5
Platelet Morphology
Time frame: Day 5
Percent of Platelets Activated as Measured by P-selectin
Time frame: Day 7
Percent of Extent of Shape Change
Time frame: Day 7
Percent of Platelets Exhibiting Hypotonic Shock Response
Time frame: Day 7
Platelet Morphology
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22882530Dumont LJ, Cancelas JA, Graminske S, Friedman KD, Vassallo RR, Whitley PH, Rugg N, Dumont DF, Herschel L, Siegal AH, Szczepiorkowski ZM, Fender L, Razatos A. In vitro and in vivo quality of leukoreduced apheresis platelets stored in a new platelet additive solution. Transfusion. 2013 May;53(5):972-80. doi: 10.1111/j.1537-2995.2012.03841.x. Epub 2012 Aug 6.
- Background: PubMed 15938735Ringwald J, Walz S, Zimmermann R, Zingsem J, Strasser E, Weisbach V, Eckstein R. Hyperconcentrated platelets stored in additive solution: aspects on productivity and in vitro quality. Vox Sang. 2005 Jul;89(1):11-8. doi: 10.1111/j.1423-0410.2005.00645.x.
- Background: PubMed 24735171Cohn CS, Stubbs J, Schwartz J, Francis R, Goss C, Cushing M, Shaz B, Mair D, Brantigan B, Heaton WA. A comparison of adverse reaction rates for PAS C versus plasma platelet units. Transfusion. 2014 Aug;54(8):1927-34. doi: 10.1111/trf.12597. Epub 2014 Apr 16.
- Background: PubMed 18034788Diedrich B, Sandgren P, Jansson B, Gulliksson H, Svensson L, Shanwell A. In vitro and in vivo effects of potassium and magnesium on storage up to 7 days of apheresis platelet concentrates in platelet additive solution. Vox Sang. 2008 Feb;94(2):96-102. doi: 10.1111/j.1423-0410.2007.01002.x. Epub 2007 Nov 22.
- Background: PubMed 11952987Gulliksson H, AuBuchon JP, Vesterinen M, Sandgren P, Larsson S, Pickard CA, Herschel I, Roger J, Tracy JE, Langweiler M; Biomedical Excellence for Safer Transfusion Working Party of the International Society of Blood Transfusion. Storage of platelets in additive solutions: a pilot in vitro study of the effects of potassium and magnesium. Vox Sang. 2002 Apr;82(3):131-6. doi: 10.1046/j.1423-0410.2002.drfgv158.x.
- Background: PubMed 9924762Dumont LJ, VandenBroeke T, Ault KA. Platelet surface P-selectin measurements in platelet preparations: an international collaborative study. Biomedical Excellence for Safer Transfusion (BEST) Working Party of the International Society of Blood Transfusion (ISBT). Transfus Med Rev. 1999 Jan;13(1):31-42. doi: 10.1016/s0887-7963(99)80086-8. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Jose Cancelas-Perez, MD, PhD principal investigator
Hoxworth Blood Center
Mehraboon S Irani, MD principal investigator
Clood Center of Wisconsin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelets stored in InterSol and Platelets stored in Plasma in people with Healthy Volunteers, run by Terumo BCT at 2 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 2 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 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 14 Jul 2017). 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?
pH of Platelets at Day 5 (time frame: Day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02298842, which also lists 6 linked publications.
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 21 Jul 2017.