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 |
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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
Scientific
Academic Medical Centre
Intensive Care Unit
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
Phone | +31 (0)20 5668224 |
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J.J.H.Hofstra@amc.uva.nl |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study acronym | Heparin Rebound |
Study objectives | Our 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) studied | Venovenous haemofiltration |
Intervention | Therapeutic 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 type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Low molecular weight heparin (LMWH) |
Primary outcome measure | Thrombin-antithrombin complexes (TATc) |
Secondary outcome measures | 1. 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 date | 01/09/2006 |
Completion date | 01/09/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 20 |
Key inclusion criteria | 1. 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 criteria | 1. Patients with known coagulation disorders 2. Patients receiving any anti-coagulant treatment for reasons other than CVVH |
Date of first enrolment | 01/09/2006 |
Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Intensive Care
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Website | http://www.amc.uva.nl |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |