Transfusion of Cold-stored Platelet Concentrates

NCT02495506 | Completed

• 1 other identifier: 2014/692
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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 . 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.

Conditions

Cardiovascular Disease Other; Bleeding; Surgery

Keywords

Cardiac surgery; bleeding; platelet transfusion

Outcome Measures

Primary Outcomes (1)

• Chest drain output (postoperative bleeding)

  Information retrieved from Medical Journal

  24 hours

Secondary Outcomes (14)

• Evidence of altered platelet function confirmed by Point-of-Care measurements

  Up to 24 hours after surgery

• Number of Blood Products transfused as a Measure of Bleeding

  From date of inclusion during hospital stay, up to 4 weeks

• Number of Participants with thromboembolic events as a Measure of Safety

  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

  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

  From date of procedure until the date of first documented event during hospital stay, up to 4 weeks

Study Arms (2)

Cold stored platelets

EXPERIMENTAL

Intervention: Leukoreduced platelet concentrates stored at 4 degrees C for treatment of bleeding after Cardiac surgery

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

Other: Room temperature platelets

Interventions

Cold stored platelets OTHER

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.

Also known as: Trombocytes, Platelet concentrates

Cold stored platelets

Room temperature platelets OTHER

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.

Also known as: Trombocytes, Platelet concentrates

Room temperature platelets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who will not provide informed consent
• Patients with congenital coagulopathies or hemostatic disorders (von willebrands disease, hemophilia etc)

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, Norway

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Geir Strandenes, MD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

• Torunn Apelseth, MD/PhD

  Haukeland University Hospital

  STUDY DIRECTOR

• Einar Kristoffersen, MD/PhD

  Haukeland University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: July 13, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 2, 2021

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)