BleedingOBS-PLATENCT06187831
Bleeding Events Before vs After Lowering Departmental Platelet Transfusion Trigger
An observational study of Bleeding and Central Line Complication, run by Thomas Kander at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding, Central Line Complication, Thrombocytopenia
- How many people
- 927 participants
- Where
- 1 siteSweden
- Study dates
- 26 Feb 2024to 17 Mar 2026
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥ 18 years of age
- Indication for central venous catheter placement.
- Patients admitted to a hematological ward at the current department
Who cannot join
- Death within 24h after insertion of CVC.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- Medical subject headings
- Hemorrhage, Thrombocytopenia, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 hours after insertion of a central venous catheter
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: From 24 hours before to 24 hours after insertion of a central venous catheter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start26 Feb 2024
- Primary completion17 Mar 2026
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 927 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Thomas Kander
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Kander, Region Skane
- Investigators
- Thomas Kander, PhD, Principal investigator, Region Skåne Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187831
- Sponsor's protocol ID
- OBS-PLATE
- Acronym
- OBS-PLATE
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request, de-identified individual participant data from this clinical trial will be shared to facilitate scientific collaboration.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Central Venous Catheterization Bleeding Events After Implementing a Lower Trigger For Platelet Transfusion - an Observational Study
- ClinicalTrials.gov ID
- NCT06187831
- Acronym / sponsor ID
- OBS-PLATE / OBS-PLATE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 927 participants (actual)
- Lead sponsor
- Thomas KanderUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- ≥ 18 years of age
- Indication for central venous catheter placement.
- Patients admitted to a hematological ward at the current department
Key exclusion criteria (1 listed)
- Death within 24h after insertion of CVC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of bleeding events grade 3 and 4
Time frame: Up to 24 hours after insertion of a central venous catheter
Incidence of bleeding events grade 3 and 4 according to the National Cancer Institute Common Terminology criteria for Adverse events (CTCAE), version 5.0.
3 secondary outcomes
Incidence of bleeding events grade 2
Time frame: 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
Time frame: From 24 hours before to 24 hours after insertion of a central venous catheter
Number of preprocedural units of platelet transfusions
Time frame: From 24 hours before to 24 hours after insertion of a central venous catheter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. Upon reasonable request, de-identified individual participant data from this clinical trial will be shared to facilitate scientific collaboration.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Kander, PhD principal investigator
Region Skåne Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding and Central Line Complication, run by Thomas Kander at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bleeding events grade 3 and 4 (time frame: Up to 24 hours after insertion of a central venous catheter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.