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
Protocol serial number	0001; NTR742
Sponsor	Academic Medical Centre (AMC) (The Netherlands)
Funder	Academic Medical Centre (AMC) (The Netherlands)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Low molecular weight heparin (LMWH)
Primary outcome measure(s)	Thrombin-antithrombin complexes (TATc)
Key secondary outcome measure(s)	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)
Completion date	01/09/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan