search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Transfusion of plasma to prevent bleeding in ICU patients.


- candidate number7880
- NTR NumberNTR2262
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-mrt-2010
- Secondary IDs10/035 / 80-82310-97-10069 ; MEC AMC / ZonMw
- Public TitleTransfusion of plasma to prevent bleeding in ICU patients.
- Scientific TitleTransfusion of fresh frozen plasma in non-bleeding ICU patients.
- ACRONYMTOPIC trial
- hypothesisFresh frozen plasma (FFP) is an effective therapy to correct 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. 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 coagulapathy 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 these patients.
- Healt Condition(s) or Problem(s) studiedIntensive care, Adverse events, Fresh frozen plasma, Coagulopathy
- Inclusion criteria1. Patients admitted to the ICU of 18 years and older;
2. INR >1,5 and <3,0;
3. Undergoing an invasive procedure, including insertion of a central venous catheter, a chest drain, percutaneous tracheotomy or drainage of abscess or fluid collection.
- Exclusion criteria1. Clinically overt bleeding at the time of the procedure;
2. Thrombocytopenia <30*109/L;
3. Use of abciximab, tirofiban, ticlopidine or activated protein C;
4. Use of acenocoumarol, fenprocoumon or warfarin;
5. Use of prothrombin complex concentrate prior to procedure;
6. Use of heparin <1 hour before the procedure;
7. Use of therapeutic doses of low molecular weight heparin <12 hours before the procedure;
8. History of congenital or acquired coagulation factor deficiency or bleeding diathesis;
9. No informed consent.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2010
- planned closingdate1-mei-2013
- Target number of participants400
- InterventionsOmitting prophylactic transfusion of FFP prior to an invasive procedure compared to transfusion of a fixed dose of 12 ml/kg.
- Primary outcomeThe primary outcome of this study will be a procedure related relevant bleeding, occurring within 24 hours after the procedure.
- Secondary outcome1. Minor bleeding within 24 hours of the intervention;
2. Onset of acute lung injury within 48 hours;
3. Correction of INR to <1,5 (after the transfusion of FFP and before the procedure, only in the transfusion arm);
4. Correction of coagulation variables;
5. Length of ventilation days;
6. Length of ICU stay;
7. ICU mortality;
8. Serious adverse events.
- Timepoints1. Identify eligible patients;
2. Randomisation after informed consent is signed;
3. Draw of baseline blood values (including coagulation parameters);
4. Transfusion of FFP or no transfusion of FFP;
5. Second draw of blood in case the subject was randomised for FFP transfusion;
6. Planned intervention/procedure (placement central venous catheter, tracheotomy, chest tube of abscess drainage);
7. 1 hour after procedure: assessment of bleeding severity;
8. 24 hours after procedure: assessment of bleeding severtity and chest x-ray (to determine lung injury).
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES M.C.A. Muller
- CONTACT for SCIENTIFIC QUERIESDr. N.P. Juffermans
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryRationale:
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.

Study design:
Prospective, multicentre, randomized, open-label, blinded end point evaluation (PROBE) design.

Study population:
ICU patients of 18 years and older with prolonged INR, who are undergoing an invasive procedure (insertion of a central venous catheter, chest drain, percutaneous tracheostomy, or percutaneous drainage of abscess/fluid collection).

Intervention:
Omitting prophylactic transfusion of FFP prior to an invasive procedure compared to transfusion of a fixed dose of 12 ml/kg.

Main study parameters/endpoints:
Primary outcome measure is relevant bleeding. Secondary outcome measures are minor bleeding, correction of INR, onset of acute lung injury, length of ventilation days, length of ICU stay and costs.
- Main changes (audit trail)
- RECORD26-mrt-2010 - 7-jun-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl