Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06187831
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-12-17
Brief Title:
Bleeding Events Before vs After Lowering Departmental Platelet Transfusion Trigger
Sponsor:
Thomas Kander
Organization:
Region Skane
Study Overview
Official Title:
Changes in Central Venous Catheterization Bleeding Events After Implementing a Lower Trigger For Platelet Transfusion - an Observational Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OBS-PLATE
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 10000 to 50000 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 50x109L to 10x109L for insertions of central venous catheters remains safe with regards to postprocedural bleeding events of grade 3-4
Baarle et al recently published a randomized controlled study where withholding prophylactic platelet transfusions before CVC placement in patients with a platelet count of 10000 to 50000 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 50x109L to 10x109L 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 50x109L 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 10x109L 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 50x109L to 10x109L 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 10x109L provided that the incidence of post-procedural grade 3-4 bleeding events in patients with a pre-procedural platelet count of 10-49 x109 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 30x109L if the incidence of post-procedural grade 3-4 bleeding events in patients with a pre-procedural platelet count of 10-49 x109 is more than two in six months more than three in one year or more than four in two years
Current Swedish guidelines recommend a pre-procedural platelet transfusion trigger of 50x109L 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 10x109L 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 50x109L to 10x109L 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 10x109L provided that the incidence of post-procedural grade 3-4 bleeding events in patients with a pre-procedural platelet count of 10-49 x109 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 30x109L if the incidence of post-procedural grade 3-4 bleeding events in patients with a pre-procedural platelet count of 10-49 x109 is more than two in six months more than three in one year or more than four in two years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None