- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02495506
Transfusion of Cold-stored Platelet Concentrates (4CPLT)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bergen, Norway
- Haukeland University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients who will not provide informed consent
- Patients with congenital coagulopathies or hemostatic disorders (von willebrands disease, hemophilia etc)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cold stored platelets
Intervention: Leukoreduced platelet concentrates stored at 4 degrees C for treatment of bleeding after Cardiac surgery
|
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.
Other Names:
|
Active Comparator: Room temperature platelets
Intervention: Leukoreduced platelet concentrates stored at 22 degrees C for treatment of bleeding after Cardiac surgery
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chest drain output (postoperative bleeding)
Time Frame: 24 hours
|
Information retrieved from Medical Journal
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evidence of altered platelet function confirmed by Point-of-Care measurements
Time Frame: Up to 24 hours after surgery
|
Evaluate in vitro changes in platelet function by use of the following Point-of-Care measurements; Multiplate whole blood impedance aggregometry, Thromboelastography, and ROTEM
|
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
|
Information retrieved from Medical Journal
|
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
|
Information retrieved from Medical Journal
|
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
|
Information retrieved from Medical Journal
|
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
|
Information retrieved from Medical Journal
|
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
|
Information retrieved from Medical Journal
|
From date of inclusion, daily during hospital stay, up to 4 weeks
|
Hematocrit
Time Frame: Up to 24 hours after surgery
|
Information retrieved from Medical Journal
|
Up to 24 hours after surgery
|
Leukocyte count
Time Frame: Up to 24 hours after surgery
|
Information retrieved from Medical Journal
|
Up to 24 hours after surgery
|
Platelet count
Time Frame: From date of inclusion, daily during hospital stay, up to 4 weeks
|
Information retrieved from Medical Journal
|
From date of inclusion, daily during hospital stay, up to 4 weeks
|
Fibrinogen
Time Frame: Up to 24 hours after surgery
|
Information retrieved from Medical Journal
|
Up to 24 hours after surgery
|
International normalized ratio (INR)
Time Frame: Up to 24 hours after surgery
|
Information retrieved from Medical Journal
|
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
|
Information retrieved from Medical Journal
|
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
|
Information retrieved from Medical Journal
|
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
|
Information retrieved from Medical Journal
|
Baseline,and the date of first documented event during hospital stay, up to 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Geir Strandenes, MD, Haukeland University Hospital
- Study Director: Torunn Apelseth, MD/PhD, Haukeland University Hospital
- Study Chair: Einar Kristoffersen, MD/PhD, Haukeland University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/692
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bleeding
-
Ethicon, Inc.Guangzhou Bioseal Biotechnology Co., Ltd.Completed
-
Waihong ChungUnknownMetoclopramide, Azithromycin, or Nondrug Pretreatment for UGIB to Reduce Second Endoscopy (MANPURSE)Upper Gastrointestinal Bleeding | Gastro Intestinal BleedingUnited States
-
Ottawa Hospital Research InstituteRecruitingGastroIntestinal Bleeding | Anticoagulant-induced BleedingCanada
-
Ethicon, Inc.CompletedHemorrhage | Soft Tissue Bleeding | Hepatic Parenchyma BleedingUnited Kingdom, Belgium
-
Hyloris DevelopmentsRecruitingBleeding From Teeth | Bleeding ProphylaxisSpain, United States, Belgium, Croatia, Hungary, Romania
-
Boston Children's HospitalBaylor College of Medicine; Children's Hospital of Philadelphia; Ann & Robert... and other collaboratorsRecruitingUpper Gastrointestinal Bleeding | Gastro Intestinal BleedingUnited States
-
Wake Forest University Health SciencesCompletedBleeding ComplicationUnited States
-
Chinese University of Hong KongCompletedGastrointestinal Bleeding | Bleeding Peptic Ulcer | Active BleedingChina
-
Chinese University of Hong KongBeijing Friendship Hospital; The First Affiliated Hospital of Soochow University and other collaboratorsCompletedAcute Upper Gastrointestinal Bleeding | Tumor BleedingHong Kong, China, Australia
-
Women and Infants Hospital of Rhode IslandActive, not recruitingAbnormal Uterine Bleeding | Abnormal Uterine Bleeding, Ovulatory Dysfunction | Abnormal Uterine Bleeding, Endometrial Hemostatic DysfunctionUnited States
Clinical Trials on Cold stored platelets
-
Jason SperryUnited States Department of DefenseActive, not recruiting
-
Jason SperryUnited States Department of DefenseCompleted
-
Moritz Stolla, MDUnited States Department of DefenseRecruitingHemorrhage | Bleeding | Surgical Blood Loss | Platelets; DefectUnited States
-
Philip SpinellaWashington University School of Medicine; United States Department of Defense; University of Pittsburgh and other collaboratorsRecruiting
-
University Health Network, TorontoQueen's University; Canadian Blood ServicesNot yet recruitingBleeding | Cardiac Surgery | Cardiopulmonary Bypass | PlateletsCanada
-
Australian and New Zealand Intensive Care Research...Australian Red CrossActive, not recruiting
-
Terumo BCTCompletedHealthy VolunteersUnited States
-
Ottawa Hospital Research InstituteNot yet recruiting
-
Medical University of GrazNovo Nordisk A/S; CSL BehringCompleted
-
Cellphire Therapeutics, Inc.Department of Health and Human ServicesTerminatedMyelodysplastic Syndromes | Myeloproliferative Disorders | Thrombocytopenia | Hematologic Malignancy | Bone Marrow Aplasia | Platelet RefractorinessUnited States, Israel, Norway