Thrombin generation after abrupt cessation versus weaning over eight hours of continuous infusion of unfractionated heparin in intensive care unit patients after discontinuation of continuous venovenous haemofiltration

ISRCTN ISRCTN33216118
DOI https://doi.org/10.1186/ISRCTN33216118
Secondary identifying numbers 0001; NTR742
Submission date
22/11/2006
Registration date
22/11/2006
Last edited
02/09/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J J H Hofstra
Scientific

Academic Medical Centre
Intensive Care Unit
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands

Phone +31 (0)20 5668224
Email J.J.H.Hofstra@amc.uva.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymHeparin Rebound
Study objectivesOur hypothesis is that rebound thrombin generation occurs in intensive care unit (ICU)-patients after abrupt cessation of heparin treatment in terms of elevation of coagulation-markers and reduction fibrinolysis-markers; intravenous (IV)-weaning of heparin reduces this rebound thrombin generation.
Ethics approval(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedVenovenous haemofiltration
InterventionTherapeutic protocol:
Prophylactic low molecular weight heparin (LMWH) will not be given within 24 hours of discontinuation of CVVH. Patients are treated with help of standard guidelines effective in our units. The full medical treatment will be under the discretion of the supervising staff-intensivists who are not directly involved in the study.

Study protocol:
Randomisation will take place using sealed envelopes:
1. In ten patients UFH infusion will be stopped simultaneous to stopping of CVVH
2. In ten patients UFH infusion will be reduced to 50% from the previous infusion rate. After four hours the infusion rate will be reduced again by 50% (25% of original infusion rate) and discontinued four hours later.

Blood samples will be taken at specific intervals to evaluate thrombin generation.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Low molecular weight heparin (LMWH)
Primary outcome measureThrombin-antithrombin complexes (TATc)
Secondary outcome measures1. Activated partial thromboplastin time (aPTT)
2. Anti-factor Xa (anti-Xa)
3. Factor VII/VIIa
4. Tissue factor (TF)
5. Tissue factor pathway inhibitor (TFPI)-antigen
6. TFPI activity
7. Protein C/activated protein C (aPC)
8. Activated protein C sensitivity ratio (aPC-sr)
9. Prothrombin fragment 1.2, ETP (endogenous thrombin potential)
10. Fibrin monomers
11. Soluble thrombomodulin
12. Plasmin-a2-anti-plasmin complexes (PAPc)
13. Plasminogen-activator inhibitor (PAI)
Overall study start date01/09/2006
Completion date01/09/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants20
Key inclusion criteria1. Patients scheduled to stop treatment with continuous venovenous haemofiltration (CVVH) because they no longer require it (physicians discretion/local protocol)
2. Age more than 18 years
3. At least 48 hours of CVVH treatment with concomitant continuous infusion of unfractionated heparin (UFH)
4. At least 36 hours of continuous UFH infusion in the last 48 hours prior to inclusion
Key exclusion criteria1. Patients with known coagulation disorders
2. Patients receiving any anti-coagulant treatment for reasons other than CVVH
Date of first enrolment01/09/2006
Date of final enrolment01/09/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Centre
Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre

Department of Intensive Care
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website http://www.amc.uva.nl
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Hospital/treatment centre

Academic Medical Centre (AMC) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan