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

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN33216118
• Date of registration: 22/11/2006
• Primary sponsor: Academic Medical Centre (AMC) (The Netherlands)
• Public title: 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 Heparin Rebound
• Date of first enrolment: Sep 1 2006
• Target sample size: 20
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN33216118
• Study type: Interventional
• Study design: Randomised controlled trial

Countries of recruitment

Netherlands

Contacts

• Name: J J H Hofstra

Key inclusion & exclusion criteria

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
Exclusion criteria: 1. Patients with known coagulation disorders
2. Patients receiving any anti-coagulant treatment for reasons other than CVVH

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Venovenous haemofiltration

Intervention(s)

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.

Primary Outcome(s)

Thrombin-antithrombin complexes (TATc)

Secondary Outcome(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)

Secondary ID(s)

0001; NTR742

Source(s) of Monetary Support

Academic Medical Centre (AMC) (The Netherlands)

Secondary Sponsor(s)

N/A