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)


Intervention pilot with fibrinogen concentrate and the combination of fibrinogen concentrate with FFP in patients with massive post/peri-operative bleeding problems


- candidate number3018
- NTR NumberNTR1218
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-jan-2008
- Secondary IDs Transfusion policy
- Public TitleIntervention pilot with fibrinogen concentrate and the combination of fibrinogen concentrate with FFP in patients with massive post/peri-operative bleeding problems
- Scientific TitleIntervention pilot with fibrinogen concentrate and the combination of fibrinogen concentrate with FFP in patients with massive post/peri-operative bleeding problems
- ACRONYMIntervention pilot with fibrinogen concentrate
- hypothesisThe combination of fibrinogen concentrate with FFP transfusion to patients with massive post/peri-operative bleeding problems is a better alternative than FFP transfusion alone, due to the prevention of dilutional coagulapathy.
- Healt Condition(s) or Problem(s) studiedGeneral surgery patients, Heart valve replacement, Post operative bleeding problems
- Inclusion criteria1. General surgery patients with massive peri-operative bloodloss, with an indication of receiving 4 units of FFP according to current guidelines.
2. Cardiothoracic surgery patients after heart valve replacement who met the criteria of increased bloodloss and indication for DDAVP.
- Exclusion criteria1. No other therapeutical anti-thrombotica are given, other than platelet-aggregation inhibitors
2. Patients with active HIV-infection
3. Patients who received FFP or fibrinogen just before the surgery
4. Patients who are hypotherm (< 30C) or with a circulatory arrest
5. Patients with a fibrinogenlevel > 2 g/L
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2008
- planned closingdate1-feb-2009
- Target number of participants100
- InterventionsComparing FFP transfusion in massive bleeding patients with the combination of fibrinogen and FFP/DDAVP
- Primary outcomeStop of bleeding after the therapy. The clinical situtation after the treatment will be compared with conventional coagulation tests (aPTT, PT, fibrinogen level).
- Secondary outcomeThrombin generation and thromboelastography measurements, measured with the CAT en TEG method.
- TimepointsBefore and after the given therapy
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. M. Pampus, van
- CONTACT for SCIENTIFIC QUERIESDr. S.E.M. Schols
- Sponsor/Initiator P.I. CARIM
- Funding
(Source(s) of Monetary or Material Support)
University Maastricht (UM)
- PublicationsMain resource:
Mittermayr M et al. Hemostatic changes after crystalloid or colloid fluid administration during major orthopedic surgery:the role of fibrinogen administration. Anesth Analg. 2007; 105
- Brief summaryPatients with post/peri operative bleeding problems usually are transfused with 4 units of FFP, unfortunately this leads to dilutional coagulapathy due to the dilution effect of the transfusion itself. The administration of factor concentrates, especially fibrinogen, consists of only a small bolus injection. There is no dilution effect of this latter treatment, no dilutional coagulopahty will occur. Briefly, fibrinogen concentrates with FFP (only 2 units) together will be a better alternative in bleeding problems than the current 4 units of FFP.
- Main changes (audit trail)
- RECORD17-jan-2008 - 3-apr-2008


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