Contact information
Type
Scientific
Primary contact
Dr J J H Hofstra
ORCID ID
Contact details
Academic Medical Centre
Intensive Care Unit
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5668224
J.J.H.Hofstra@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
0001; NTR742
Study information
Scientific title
Acronym
Heparin Rebound
Study hypothesis
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
Ethics approval received from the local medical ethics committee
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Low molecular weight heparin (LMWH)
Primary outcome measures
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 trial start date
01/09/2006
Overall trial end date
01/09/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
20
Participant exclusion criteria
1. Patients with known coagulation disorders
2. Patients receiving any anti-coagulant treatment for reasons other than CVVH
Recruitment start date
01/09/2006
Recruitment end date
01/09/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Department of Intensive Care
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Centre (AMC) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary