Bleeding Events Before vs After Lowering Departmental Platelet Transfusion Trigger (OBS-PLATE)

Changes in Central Venous Catheterization Bleeding Events After Implementing a Lower Trigger For Platelet Transfusion - an Observational Study

Central venous catheters are essential when administering treatment for hematological conditions. Many patients have a decreased platelet count which increases the risk for bleeding complications.

Baarle et al. recently published a randomized controlled study where withholding prophylactic platelet transfusions before CVC placement in patients with a platelet count of 10,000 to 50,000 per cubic millimeter did not meet the predefined margin for non-inferiority for postprocedural bleeding events (PMID: 37224197). However, bleedings grade 2 (defined as bleeding that requires external compression) were included despite lacking clinical significance.

The aim of the present study is to investigate whether lowering the preprocedural platelet transfusion trigger from 50x10^9/L to 10x10^9/L for insertions of central venous catheters remains safe with regards to postprocedural bleeding events of grade 3-4.

Study Overview

• Status: Completed
• Conditions: Hematologic Diseases; Bleeding; Thrombocytopenia; Central Line Complication

Detailed Description

This is a single-center, retrospective, observational study. All adult hematologic patients receiving a central venous catheter in the department of intensive and perioperative care at Skåne University Hospital in Lund, Sweden will be eligible for inclusion.

Current Swedish guidelines recommend a pre-procedural platelet transfusion trigger of 50x10^9/L to decrease the risk of bleeding during and after the procedure. However, these guidelines are based on data from an era when the landmark technique was predominant, and the bleeding complication incidence has decreased with the widespread use of real-time ultrasound guidance. Thus, our departmental pre-procedural platelet transfusion trigger for CVC placement was lowered from 50 to 10x10^9/L in March 2023. This corresponds to the threshold commonly used in hematologic patients to prevent spontaneous bleeding.

This study is set to investigate if the incidence of grade 3-4 postprocedural bleeding events have increased after the change in platelet transfusion trigger from 50x10^9/L to 10x10^9/L before the insertion of a CVC in hematologic patients.

Approximately 110 CVCs are placed annually in hematological patients at the current institution. Retrospective data will be extracted from the electronic charts and prospective data will be collected continuously. Intervention checkpoints will be put in place to control for grade 3-4 bleeding events:

1. The transfusion trigger will remain at 10x10^9/L provided that the incidence of post-procedural grade 3-4 bleeding events in patients with a pre-procedural platelet count of 10-49 x10^9 is less than three in six months, less than four in one year or less than five in two years.
2. The transfusion trigger will be increased to 30x10^9/L if the incidence of post-procedural grade 3-4 bleeding events in patients with a pre-procedural platelet count of 10-49 x10^9 is more than two in six months, more than three in one year or more than four in two years.

• Study Type: Observational
• Enrollment (Actual): 927

Contacts and Locations

Study Locations

• Sweden
  • Lunds Universitet
    • Lund, Lunds Universitet, Sweden, 22650
      • Thomas Kander

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients ≥18 years of age admitted to a hematological ward at the current department, with an indication for CVC placement, will be eligible for inclusion in the study.

Description

Inclusion Criteria:

• ≥ 18 years of age
• Indication for central venous catheter placement.
• Patients admitted to a hematological ward at the current department

Exclusion Criteria:

• Death within 24h after insertion of CVC.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Before the change of the departmental pre-procedural platelet transfusion trigger for CVC placement; Patients ≥18 years of age admitted to a hematological ward at the current department, with an indication for CVC placement will be eligible for inclusion in the study
After the change of the departmental pre-procedural platelet transfusion trigger for CVC placement; Patients ≥18 years of age admitted to a hematological ward at the current department, with an indication for CVC placement will be eligible for inclusion in the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of bleeding events grade 3 and 4	Incidence of bleeding events grade 3 and 4 according to the National Cancer Institute Common Terminology criteria for Adverse events (CTCAE), version 5.0.	Up to 24 hours after insertion of a central venous catheter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of bleeding events grade 2	Incidence of bleeding events grade 2 according to the National Cancer Institute Common Terminology criteria for Adverse events (CTCAE), version 5.0	Up to 24 hours after insertion of a central venous catheter
Number of patients receiving pre-procedural platelet transfusion Number of patients receiving pre-procedural platelet transfusion	Number of patients receiving pre-procedural platelet transfusion	From 24 hours before to 24 hours after insertion of a central venous catheter
Number of preprocedural units of platelet transfusions	Number of preprocedural units of platelet transfusions	From 24 hours before to 24 hours after insertion of a central venous catheter

Collaborators and Investigators

• Sponsor: Thomas Kander
• Investigators: Principal Investigator: Thomas Kander, PhD, Region Skåne Sweden

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Actual): March 17, 2026
• Study Completion (Actual): March 17, 2026

Study Registration Dates

• First Submitted: December 17, 2023
• First Submitted That Met QC Criteria: December 17, 2023
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cytopenia; Pathologic Processes; Blood Platelet Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Thrombocytopenia; Hematologic Diseases; Hemorrhage
• Other Study ID Numbers: OBS-PLATE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon reasonable request, de-identified individual participant data from this clinical trial will be shared to facilitate scientific collaboration.
• IPD Sharing Time Frame: After the publication of the study up to 3 years after the publication of the study
• IPD Sharing Access Criteria: Researchers may submit requests through the specified channel, detailing the purpose and proposed analyses. Approved applicants will sign a data access agreement, ensuring responsible and transparent use of the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No