Blood Coagulation DisordersTOPICNCT01143909
Transfusion of Fresh Frozen Plasma in Non-bleeding Intensive Care Unit (ICU) Patients
A study testing omitting FFP transfusion before an intervention in people with Blood Coagulation Disorders and Hemorrhage, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 4 sites in Netherlands.
Trial summary
With the aim to restrict inappropriate fresh frozen plasma (FFP) transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgroup of intensive care (ICU) patients undergoing an invasive procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Coagulation Disorders, Hemorrhage
- What is being tested?
- omitting FFP transfusion before an intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 4 sitesNetherlands
- Study dates
- May 2010to Jun 2013
- Phase
- Interventional
- 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
Who may be able to join
- 18 years and older
- INR >1.5 and <3.0
- undergoing invasive procedure (insertion of a central venous catheter, a chest drain, percutaneous tracheostomy)
Who cannot join
- clinically overt bleeding at the time of the procedure (excludes minor epistaxis, minor gum bleeding, microscopic hematuria, superficial bruises, or normal menses)
- thrombocytopenia of < 30 x 109/L.
- use of abciximab, tirofiban, ticlopidine or activated protein C
- use of heparin < 1 hour prior to the procedure, or low molecular weight heparin in therapeutic doses < 12 hours prior to procedure
- history of congenital or acquired coagulation factor deficiency or bleeding diathesis
- no informed consent
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Academic Medical Centre - University of Amsterdam
Amsterdam, 1105 AZ
Ter Gooi Ziekenhuizen
Hilversum, 1231 XZ
Leids Universitair Medisch Centrum
Leiden, 2333 XZ
Diakonessenhuis
Utrecht, Utrecht, 3582 KE
About this study
Official title: Transfusion of Fresh Frozen Plasma in Non-bleeding ICU Patients
With the aim to restrict inappropriate fresh frozen plasma (FFP) transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgroup of intensive care (ICU) patients undergoing an invasive procedure. The objective is to assess the effectiveness and costs of omitting prophylactic FFP transfusion compared to current practice of prophylactic transfusion, in non-bleeding ICU patients with a coagulopathy.
Read the detailed description
Rationale: Fresh frozen plasma (FFP) is an effective therapy to correct for a deficiency of multiple coagulation factors during bleeding. In past years, use of FFP has increased, in particular in patients on the Intensive Care Unit (ICU), and has expanded to include prophylactic use in patients with a coagulopathy prior to undergoing an invasive procedure. Retrospective studies suggest that prophylactic use of FFP does not prevent bleeding, but carries the risk of transfusion-related morbidity. However, up to 50% of FFP is administered to non-bleeding ICU patients.
Objective: With the aim to restrict inappropriate FFP transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgroup of ICU patients with a coagulopathy undergoing an invasive procedure. The objective is to assess the effectiveness and costs of prophylactic FFP transfusion (current practice) compared to no prophylactic transfusion, in non-bleeding ICU patients with a coagulopathy, prior to undergoing an invasive procedure (e.g. placement of central venous catheter, tracheostomy, chest tube).
Study design: Prospective, multicentre, randomized, open-label, blinded end point evaluation (PROBE) design.
- Conditions
- Blood Coagulation Disorders, Hemorrhage
- Being tested
- omitting FFP transfusion before an intervention
- Keywords
- Fresh frozen plasma, Coagulopathy, Intensive care, Adverse effects, Lung injury
- Medical subject headings
- Blood Coagulation Disorders, Hemorrhage, Hemostatic Disorders, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omitting FFP transfusion before an interventionOther
In the interventional group FFP transfusion is omitted before performing a procedure (e.g. placement of central venous catheter, tracheostomy, chest tube)
| Study group | Role | What they receive |
|---|---|---|
| No FFP transfusion prior to intervention | Experimental | Patients with a coagulopathy (INR 1,5-3,0), who are randomized to omitting transfusion of fresh frozen plasma before they undergo an intervention. Receives: Other: omitting FFP transfusion before an intervention |
| FFP transfusion prior to intervention | No intervention | Patients with a coagulopathy (INR 1,5-3,0), who are randomized to transfusion of fresh frozen plasma before they undergo an intervention. This is considered standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure-related relevant bleeding, occurring within 24 hours after the procedure.
Relevant bleeding will be defined using a validated tool for assessment of bleeding in the critically ill.
An assessment of bleeding will be standardized and performed by an independent research physician or intensivist blinded to the transfusion strategy 1 and 24 hours after the procedure and when clinically indicated.
Measured: 24 hours after the procedure
Secondary outcomes (4)
minor bleeding within 24 hours
Measured: within 24 hours of the procedure
onset of acute lung injury within 48 hours.
Lung injury will be evaluated by P/F ratio, change in ventilator settings, chest x-ray and Lung Injury Score.
Measured: 48 hours within the intervention
effect of FFP transfusion on coagulation parameters
a range of coagulation parameters will be evaluated to assess efficacy of FFP transfusion in these patients
Measured: within 24 hours of transfusion of FFP
evaluation of costs
Evaluation of costs in the two different groups will be made. Length of stay, number of ventilation days, differences in medication use, all will be taken into account.
Measured: up to 28 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Blood Coagulation DisordersStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Nicole P Juffermans, MD, PhD, Principal investigator, Academic Medical Centre - University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143909
- Sponsor's protocol ID
- ZonMw-80823109710069
- Other IDs
- NTR2262
- Acronym
- TOPIC
- Status last verified
- Jun 2010
- First submitted
- 14 Jun 2010
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Straat M, Muller MC, Meijers JC, Arbous MS, Spoelstra-de Man AM, Beurskens CJ, Vroom MB, Juffermans NP. Effect of transfusion of fresh frozen plasma on parameters of endothelial condition and inflammatory status in non-bleeding critically ill patients: a prospective substudy of a randomized trial. Crit Care. 2015 Apr 15;19(1):163. doi: 10.1186/s13054-015-0828-6.
PubMed 25880761Muller MC, Straat M, Meijers JC, Klinkspoor JH, de Jonge E, Arbous MS, Schultz MJ, Vroom MB, Juffermans NP. Fresh frozen plasma transfusion fails to influence the hemostatic balance in critically ill patients with a coagulopathy. J Thromb Haemost. 2015 Jun;13(6):989-97. doi: 10.1111/jth.12908. Epub 2015 Apr 18.
PubMed 25809519Muller MC, de Jonge E, Arbous MS, Spoelstra-de Man AM, Karakus A, Vroom MB, Juffermans NP. Transfusion of fresh frozen plasma in non-bleeding ICU patients--TOPIC trial: study protocol for a randomized controlled trial. Trials. 2011 Dec 23;12:266. doi: 10.1186/1745-6215-12-266.
PubMed 22196464
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion of Fresh Frozen Plasma in Non-bleeding ICU Patients
- ClinicalTrials.gov ID
- NCT01143909
- Acronym / sponsor ID
- TOPIC / ZonMw-80823109710069
- Conditions
- Blood Coagulation Disorders, Hemorrhage
- Keywords
- Fresh frozen plasma, Coagulopathy, Intensive care, Adverse effects, Lung injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- May 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Jun 2010 (estimated)
- 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.
With the aim to restrict inappropriate fresh frozen plasma (FFP) transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgroup of intensive care (ICU) patients undergoing an invasive procedure. The objective is to assess the effectiveness and costs of omitting prophylactic FFP transfusion compared to current practice of prophylactic transfusion, in non-bleeding ICU patients with a coagulopathy.
Detailed description
Rationale: Fresh frozen plasma (FFP) is an effective therapy to correct for a deficiency of multiple coagulation factors during bleeding. In past years, use of FFP has increased, in particular in patients on the Intensive Care Unit (ICU), and has expanded to include prophylactic use in patients with a coagulopathy prior to undergoing an invasive procedure. Retrospective studies suggest that prophylactic use of FFP does not prevent bleeding, but carries the risk of transfusion-related morbidity. However, up to 50% of FFP is administered to non-bleeding ICU patients.
Objective: With the aim to restrict inappropriate FFP transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgroup of ICU patients with a coagulopathy undergoing an invasive procedure. The objective is to assess the effectiveness and costs of prophylactic FFP transfusion (current practice) compared to no prophylactic transfusion, in non-bleeding ICU patients with a coagulopathy, prior to undergoing an invasive procedure (e.g. placement of central venous catheter, tracheostomy, chest tube).
Study design: Prospective, multicentre, randomized, open-label, blinded end point evaluation (PROBE) design.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No FFP transfusion prior to intervention | Experimental | Other: omitting FFP transfusion before an interventionPatients with a coagulopathy (INR 1,5-3,0), who are randomized to omitting transfusion of fresh frozen plasma before they undergo an intervention. |
| FFP transfusion prior to intervention | No intervention | –Patients with a coagulopathy (INR 1,5-3,0), who are randomized to transfusion of fresh frozen plasma before they undergo an intervention. This is considered standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older
- INR >1.5 and <3.0
- undergoing invasive procedure (insertion of a central venous catheter, a chest drain, percutaneous tracheostomy)
Key exclusion criteria (6 listed)
- clinically overt bleeding at the time of the procedure (excludes minor epistaxis, minor gum bleeding, microscopic hematuria, superficial bruises, or normal menses)
- thrombocytopenia of < 30 x 109/L.
- use of abciximab, tirofiban, ticlopidine or activated protein C
- use of heparin < 1 hour prior to the procedure, or low molecular weight heparin in therapeutic doses < 12 hours prior to procedure
- history of congenital or acquired coagulation factor deficiency or bleeding diathesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omitting FFP transfusion before an interventionIn the interventional group FFP transfusion is omitted before performing a procedure (e.g. placement of central venous catheter, tracheostomy, chest tube) | Other | No FFP transfusion prior to intervention |
Primary outcome
Procedure-related relevant bleeding, occurring within 24 hours after the procedure.
Time frame: 24 hours after the procedure
Relevant bleeding will be defined using a validated tool for assessment of bleeding in the critically ill. An assessment of bleeding will be standardized and performed by an independent research physician or intensivist blinded to the transfusion strategy 1 and 24 hours after the procedure and when clinically indicated.
4 secondary outcomes
minor bleeding within 24 hours
Time frame: within 24 hours of the procedure
onset of acute lung injury within 48 hours.
Time frame: 48 hours within the intervention
effect of FFP transfusion on coagulation parameters
Time frame: within 24 hours of transfusion of FFP
evaluation of costs
Time frame: up to 28 days after inclusion
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 17 Jun 2013.
- Derived from this study: PubMed 25880761Straat M, Muller MC, Meijers JC, Arbous MS, Spoelstra-de Man AM, Beurskens CJ, Vroom MB, Juffermans NP. Effect of transfusion of fresh frozen plasma on parameters of endothelial condition and inflammatory status in non-bleeding critically ill patients: a prospective substudy of a randomized trial. Crit Care. 2015 Apr 15;19(1):163. doi: 10.1186/s13054-015-0828-6.
- Derived from this study: PubMed 25809519Muller MC, Straat M, Meijers JC, Klinkspoor JH, de Jonge E, Arbous MS, Schultz MJ, Vroom MB, Juffermans NP. Fresh frozen plasma transfusion fails to influence the hemostatic balance in critically ill patients with a coagulopathy. J Thromb Haemost. 2015 Jun;13(6):989-97. doi: 10.1111/jth.12908. Epub 2015 Apr 18.
- Derived from this study: PubMed 22196464Muller MC, de Jonge E, Arbous MS, Spoelstra-de Man AM, Karakus A, Vroom MB, Juffermans NP. Transfusion of fresh frozen plasma in non-bleeding ICU patients--TOPIC trial: study protocol for a randomized controlled trial. Trials. 2011 Dec 23;12:266. doi: 10.1186/1745-6215-12-266.
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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.
Nicole P Juffermans, MD, PhD principal investigator
Academic Medical Centre - University of Amsterdam
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omitting FFP transfusion before an intervention in people with Blood Coagulation Disorders and Hemorrhage, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 4 sites in Netherlands.
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 6 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 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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?
Procedure-related relevant bleeding, occurring within 24 hours after the procedure. (time frame: 24 hours after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01143909, which also lists 3 linked publications.
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 17 Jun 2013.