Condition category
Haematological Disorders
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
02/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl

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

Publication citations

Additional files

Editorial Notes