Cardiovascular Disease Other4CPLTNCT02495506
Transfusion of Cold-stored Platelet Concentrates
A study testing Cold stored platelets and Room temperature platelets in people with Cardiovascular Disease Other and Bleeding, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
This study will investigate the effects of Leukocyte reduced cold-stored platelet transfusions used in treatment of immediate postoperative blood loss in patients undergoing thoracic surgery in combination with extracorporal circulation. Today platelet concentrates are stored at 22 degrees C . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease Other, Bleeding, Surgery
- What is being tested?
- Cold stored platelets and Room temperature platelets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2015to Dec 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing urgent/semiurgent thoracic surgery
- Expected long extracorporal time (>120 minutes) and/or use of dual platelet inhibition drugs
- Patients likely to require platelet transfusion
- Patients capable of providing informed consent
Who cannot join
- Patients who will not provide informed consent
- Patients with congenital coagulopathies or hemostatic disorders (von willebrands disease, hemophilia etc)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transfusion Therapy in Patients Undergoing Cardiac Surgery in Combination With Late Withdrawal of Drug Induced Platelet Inhibition or Prolonged Extra-corporal Circulation Time
This study will investigate the effects of Leukocyte reduced cold-stored platelet transfusions used in treatment of immediate postoperative blood loss in patients undergoing thoracic surgery in combination with extracorporal circulation. Today platelet concentrates are stored at 22 degrees C .
This is a prospective, randomized, unblinded, non-inferiority two-arm study. Aim of study is to compare platelet function in bleeding patients transfused with leukoreduced platelet concentrates stored cold (4 degrees C) and in room temperature (22 degrees C). Storage time for RCT platelet concentrates are up to 7 days. Patients with expected time on extracorporal circulation more than 120 minutes and/or medical platelet inhibitors will be included.
Read more
Platelet function will be assessed by use of Multiplate Aggregometry, Thromboelastography (TEG) and/or Thromboelastometry (ROTEM). In addition post operative bleeding, and adverse events will be recorded.
After completion of recruitment of patients to RCT study of platelet stored cold for up to 7 days, a follow up prospective observational study of platelets stored cold for up to 14 days is performed.
Additonal information 2019, May 03: This trial was registered on Clinical Trials.gov with an original plan to use non-inferiority testing of between-group differences in platelet function. Due to lack of evidence needed to set acceptable tolerance margins for the non-inferiority testing, independent reviewers with expertise in clinical trial design recommended they be replaced by standard tests of superiority, commensurate with the early phase of the trial. Further, post-operative chest tube drainage was chosen as the primary outcome to better present the pilot study's focus on the control of clinically significant bleeding.
Read the detailed description
This is a prospective, randomized, unblinded, non-inferiority two-arm study were Arm 1 patients will receive Leukocyte reduced cold-stored platelet concentrates and Arm 2 patients will receive leukoreduced room-temperature-stored (22 degrees C) platelet concentrates. Patients with expected time on extracorporal circulation more than 120 minutes and/or medical platelet inhibitors will be included.
The number of patients included is set to 20 patients in each arm, as there is not sufficient information available in the literature to conduct power calculations. The hypothesis is that cold stored platelets are not inferior to room temperature platelet concentrates.
Baseline patient data and information on intervention and post operative recovery will be collected from the Medical journals together with information on transfusion episodes and Blood Components. Blood samples will be retrieved from study participants at specific intervals: baseline, immediately after surgery, at arrival at ICU, before and after (every) platelet transfusion episode, 24 hours post operation, and if indicated, during hospital stay. Blood samples will be investigated for platelet function, coagulation parameters, hematologic parameters, and other risk factors for adverse events. If transfusion reactions occur, additional test of patient and the Blood Component(s) transfused will be performed. Samples will be collected and stored in the biobank for cytokines, complement and allergy analysis.
After completion of recruitment of patients to RCT study of platelet concentrates stored cold for up to 7 days, a follow up prospective observational study of platelets stored cold for up to 14 days is performed.
Additonal information 2019, May 03: This trial was registered on Clinical Trials.gov with an original plan to use non-inferiority testing of between-group differences in platelet function. Due to lack of evidence needed to set acceptable tolerance margins for the non-inferiority testing, independent reviewers with expertise in clinical trial design recommended they be replaced by standard tests of superiority, commensurate with the early phase of the trial. Further, post-operative chest tube drainage was chosen as the primary outcome to better present the pilot study's focus on the control of clinically significant bleeding.
- Conditions
- Cardiovascular Disease Other, Bleeding, Surgery
- Being tested
- Cold stored platelets, Room temperature platelets
- Keywords
- Cardiac surgery, bleeding, platelet transfusion
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold stored plateletsOther
Also called Trombocytes, Platelet concentrates
Intervention: Leukoreduced platelet concentrates stored at 4 degrees C for treatment of bleeding after Cardiac surgery. Storage time for RCT platelet concentrates are up to 7 days.
Room temperature plateletsOther
Also called Trombocytes, Platelet concentrates
Intervention: Leukoreduced platelet concentrates stored at 22 degrees C for treatment of bleeding after Cardiac surgery. Storage time for RCT platelet concentrates are up to 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Cold stored platelets | Experimental | Intervention: Leukoreduced platelet concentrates stored at 4 degrees C for treatment of bleeding after Cardiac surgery Receives: Other: Cold stored platelets |
| Room temperature platelets | Active comparator | Intervention: Leukoreduced platelet concentrates stored at 22 degrees C for treatment of bleeding after Cardiac surgery Receives: Other: Room temperature platelets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest drain output (postoperative bleeding)
Information retrieved from Medical Journal
Measured: 24 hours
Secondary outcomes (14)
Evidence of altered platelet function confirmed by Point-of-Care measurements
Evaluate in vitro changes in platelet function by use of the following Point-of-Care measurements; Multiplate whole blood impedance aggregometry, Thromboelastography, and ROTEM
Measured: Up to 24 hours after surgery
Number of Blood Products transfused as a Measure of Bleeding
Information retrieved from Medical Journal
Measured: From date of inclusion during hospital stay, up to 4 weeks
Number of Participants with thromboembolic events as a Measure of Safety
Information retrieved from Medical Journal
Measured: From date of procedure until the date of first documented event during hospital stay, up to 4 weeks
Number of Participants with other adverse events as a Measure of Safety
Information retrieved from Medical Journal
Measured: From date of procedure until the date of first documented event during hospital stay, up to 4 weeks
Number of Participants with transfusion complication as a Measure of Safety
Information retrieved from Medical Journal
Measured: From date of procedure until the date of first documented event during hospital stay, up to 4 weeks
Hemoglobin value
Information retrieved from Medical Journal
Measured: From date of inclusion, daily during hospital stay, up to 4 weeks
Hematocrit
Information retrieved from Medical Journal
Measured: Up to 24 hours after surgery
Leukocyte count
Information retrieved from Medical Journal
Measured: Up to 24 hours after surgery
Platelet count
Information retrieved from Medical Journal
Measured: From date of inclusion, daily during hospital stay, up to 4 weeks
Fibrinogen
Information retrieved from Medical Journal
Measured: Up to 24 hours after surgery
International normalized ratio (INR)
Information retrieved from Medical Journal
Measured: Up to 24 hours after surgery
Activated Partial Thromboplastin time (APTT)
Information retrieved from Medical Journal
Measured: Baseline, up to 24 hours and at the date of first documented thromboembolic event during hospital stay, up to 4 weeks
Allergy analysis as a Measure of Risk of transfusion complication
Information retrieved from Medical Journal
Measured: Baseline,and the date of first documented event during hospital stay, up to 4 weeks
Complement analysis as a Measure of risk of transfusion complication
Information retrieved from Medical Journal
Measured: Baseline,and the date of first documented event during hospital stay, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease OtherStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geir Strandenes, MD, Principal investigator, Haukeland University HospitalTorunn Apelseth, MD/PhD, Study director, Haukeland University HospitalEinar Kristoffersen, MD/PhD, Study chair, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495506
- Sponsor's protocol ID
- 2014/692
- Acronym
- 4CPLT
- Status last verified
- Sep 2018
- First submitted
- 19 Jun 2015
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion Therapy in Patients Undergoing Cardiac Surgery in Combination With Late Withdrawal of Drug Induced Platelet Inhibition or Prolonged Extra-corporal Circulation Time
- ClinicalTrials.gov ID
- NCT02495506
- Acronym / sponsor ID
- 4CPLT / 2014/692
- Conditions
- Cardiovascular Disease Other, Bleeding, Surgery
- Keywords
- Cardiac surgery, bleeding, platelet transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 13 Jul 2015 (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.
This study will investigate the effects of Leukocyte reduced cold-stored platelet transfusions used in treatment of immediate postoperative blood loss in patients undergoing thoracic surgery in combination with extracorporal circulation. Today platelet concentrates are stored at 22 degrees C .
This is a prospective, randomized, unblinded, non-inferiority two-arm study. Aim of study is to compare platelet function in bleeding patients transfused with leukoreduced platelet concentrates stored cold (4 degrees C) and in room temperature (22 degrees C). Storage time for RCT platelet concentrates are up to 7 days. Patients with expected time on extracorporal circulation more than 120 minutes and/or medical platelet inhibitors will be included.
Platelet function will be assessed by use of Multiplate Aggregometry, Thromboelastography (TEG) and/or Thromboelastometry (ROTEM). In addition post operative bleeding, and adverse events will be recorded.
After completion of recruitment of patients to RCT study of platelet stored cold for up to 7 days, a follow up prospective observational study of platelets stored cold for up to 14 days is performed.
Additonal information 2019, May 03: This trial was registered on Clinical Trials.gov with an original plan to use non-inferiority testing of between-group differences in platelet function. Due to lack of evidence needed to set acceptable tolerance margins for the non-inferiority testing, independent reviewers with expertise in clinical trial design recommended they be replaced by standard tests of superiority, commensurate with the early phase of the trial. Further, post-operative chest tube drainage was chosen as the primary outcome to better present the pilot study's focus on the control of clinically significant bleeding.
Detailed description
This is a prospective, randomized, unblinded, non-inferiority two-arm study were Arm 1 patients will receive Leukocyte reduced cold-stored platelet concentrates and Arm 2 patients will receive leukoreduced room-temperature-stored (22 degrees C) platelet concentrates. Patients with expected time on extracorporal circulation more than 120 minutes and/or medical platelet inhibitors will be included.
The number of patients included is set to 20 patients in each arm, as there is not sufficient information available in the literature to conduct power calculations. The hypothesis is that cold stored platelets are not inferior to room temperature platelet concentrates.
Baseline patient data and information on intervention and post operative recovery will be collected from the Medical journals together with information on transfusion episodes and Blood Components. Blood samples will be retrieved from study participants at specific intervals: baseline, immediately after surgery, at arrival at ICU, before and after (every) platelet transfusion episode, 24 hours post operation, and if indicated, during hospital stay. Blood samples will be investigated for platelet function, coagulation parameters, hematologic parameters, and other risk factors for adverse events. If transfusion reactions occur, additional test of patient and the Blood Component(s) transfused will be performed. Samples will be collected and stored in the biobank for cytokines, complement and allergy analysis.
After completion of recruitment of patients to RCT study of platelet concentrates stored cold for up to 7 days, a follow up prospective observational study of platelets stored cold for up to 14 days is performed.
Additonal information 2019, May 03: This trial was registered on Clinical Trials.gov with an original plan to use non-inferiority testing of between-group differences in platelet function. Due to lack of evidence needed to set acceptable tolerance margins for the non-inferiority testing, independent reviewers with expertise in clinical trial design recommended they be replaced by standard tests of superiority, commensurate with the early phase of the trial. Further, post-operative chest tube drainage was chosen as the primary outcome to better present the pilot study's focus on the control of clinically significant bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold stored platelets | Experimental | Other: Cold stored plateletsIntervention: Leukoreduced platelet concentrates stored at 4 degrees C for treatment of bleeding after Cardiac surgery |
| Room temperature platelets | Active comparator | Other: Room temperature plateletsIntervention: Leukoreduced platelet concentrates stored at 22 degrees C for treatment of bleeding after Cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing urgent/semiurgent thoracic surgery
- Expected long extracorporal time (>120 minutes) and/or use of dual platelet inhibition drugs
- Patients likely to require platelet transfusion
- Patients capable of providing informed consent
Key exclusion criteria (2 listed)
- Patients who will not provide informed consent
- Patients with congenital coagulopathies or hemostatic disorders (von willebrands disease, hemophilia etc)
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 |
|---|---|---|
| Cold stored plateletsAlso: Trombocytes, Platelet concentratesIntervention: Leukoreduced platelet concentrates stored at 4 degrees C for treatment of bleeding after Cardiac surgery. Storage time for RCT platelet concentrates are up to 7 days. | Other | Cold stored platelets |
| Room temperature plateletsAlso: Trombocytes, Platelet concentratesIntervention: Leukoreduced platelet concentrates stored at 22 degrees C for treatment of bleeding after Cardiac surgery. Storage time for RCT platelet concentrates are up to 7 days. | Other | Room temperature platelets |
Primary outcome
Chest drain output (postoperative bleeding)
Time frame: 24 hours
Information retrieved from Medical Journal
14 secondary outcomes
Evidence of altered platelet function confirmed by Point-of-Care measurements
Time frame: Up to 24 hours after surgery
Number of Blood Products transfused as a Measure of Bleeding
Time frame: From date of inclusion during hospital stay, up to 4 weeks
Number of Participants with thromboembolic events as a Measure of Safety
Time frame: From date of procedure until the date of first documented event during hospital stay, up to 4 weeks
Number of Participants with other adverse events as a Measure of Safety
Time frame: From date of procedure until the date of first documented event during hospital stay, up to 4 weeks
Number of Participants with transfusion complication as a Measure of Safety
Time frame: From date of procedure until the date of first documented event during hospital stay, up to 4 weeks
Hemoglobin value
Time frame: From date of inclusion, daily during hospital stay, up to 4 weeks
Hematocrit
Time frame: Up to 24 hours after surgery
Leukocyte count
Time frame: Up to 24 hours after surgery
Platelet count
Time frame: From date of inclusion, daily during hospital stay, up to 4 weeks
Fibrinogen
Time frame: Up to 24 hours after surgery
International normalized ratio (INR)
Time frame: Up to 24 hours after surgery
Activated Partial Thromboplastin time (APTT)
Time frame: Baseline, up to 24 hours and at the date of first documented thromboembolic event during hospital stay, up to 4 weeks
Allergy analysis as a Measure of Risk of transfusion complication
Time frame: Baseline,and the date of first documented event during hospital stay, up to 4 weeks
Complement analysis as a Measure of risk of transfusion complication
Time frame: Baseline,and the date of first documented event during hospital stay, up to 4 weeks
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 2 Jun 2021.
- 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.
Geir Strandenes, MD principal investigator
Haukeland University Hospital
Torunn Apelseth, MD/PhD study director
Haukeland University Hospital
Einar Kristoffersen, MD/PhD study chair
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold stored platelets and Room temperature platelets in people with Cardiovascular Disease Other and Bleeding, run by Haukeland University Hospital at 1 site in Norway.
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 2 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 2 Jun 2021. 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 Norway. 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?
Chest drain output (postoperative bleeding) (time frame: 24 hours). 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 2 Jun 2021; AzTrials last refreshed its copy on 6 Nov 2026.