Bleeding Events Before vs After Lowering Departmental Platelet Transfusion Trigger

NCT06187831 | Completed

• 1 other identifier: OBS-PLATE
• Study Type: observational
• Target: 927
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding; Central Line Complication; Thrombocytopenia; Hematologic Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of bleeding events grade 2

  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

  From 24 hours before to 24 hours after insertion of a central venous catheter

• Number of preprocedural units of platelet transfusions

  From 24 hours before to 24 hours after insertion of a central venous catheter

Study Arms (2)

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

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Death within 24h after insertion of CVC.

Sponsors & Collaborators

• Thomas Kander: lead

Study Sites (1)

Thomas Kander

Lund, Lunds Universitet, 22650, Sweden

Location

MeSH Terms

Conditions

Hemorrhage; Thrombocytopenia; Hematologic Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood Platelet Disorders; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Thomas Kander, PhD

  Region Skåne Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 3, 2024
• Study Start: February 26, 2024
• Primary Completion: March 17, 2026
• Study Completion: March 17, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After the publication of the study up to 3 years after the publication of the study
• 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.

Locations

SE (1)