Bleeding Events Before vs After Lowering Departmental Platelet Transfusion Trigger

NCT ID: NCT06187831

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-26
• Study Completion Date: 2026-04-20

Brief Summary

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.

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.

Conditions

Bleeding; Central Line Complication; Thrombocytopenia; Hematologic Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Kander

OTHER

Sponsor Role: lead

Responsible Party

Thomas Kander

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thomas Kander, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Skåne Sweden

Locations

Thomas Kander

Lund, Lunds Universitet, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Thomas Kander, PhD

Role: CONTACT

thomas.kander@med.lu.se

+46 46 171163

Mathias Lazarevic Lindblad, MD

Role: CONTACT

mathias.lazareviclindblad@skane.se

+46 46 175385

Facility Contacts

Thomas Kander, PhD

Role: primary

thomas.kander@med.lu.se

046171163

Mathias Lazarevic Lindblad, MD

Role: backup

mathias.lazarevic_lindblad@med.lu.se

Other Identifiers

OBS-PLATE

Identifier Type: -

Identifier Source: org_study_id