We aim to observe in whole blood at patients core temperature and normotemperature how mild therapeutic hypothermia affects coagulation and in particular fibrinogen, in post cardiac arrest patients.
ID
Source
Brief title
Condition
- Other condition
- Cardiac arrhythmias
Synonym
Health condition
stollingsapparaat
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The hypothermic effects on coagulation will be observed by using
thromboelastometry. The main parameters are 1) maximum clot firmness; 2)
clotting time and 3) maximum clot lysis.
Secondary outcome
Not applicable
Background summary
Mild therapeutic hypothermia (32-34°) improves neurological outcome in patients
successfully resuscitated after cardiac arrest. Although hypothermia protects
neurologic functions it leads to an unknown degree of impairment of the
coagulation.
Infusion with cold crystalloids to induce hypothermia to 33° causes
coagulopathy by dilution and causes a decrease in function of platelets. When
temperature declines even further non in vivo studies showed that synthesis and
kinetics of clotting enzymes, thrombin generation and plasminogen activator
inhibitors may be affected. One clinical study showed a slightly prolonged
clotting time as sole effect of mild hypothermia on coagulation but
measurements were not performed on core temperature therefore causing a
possible underestimated of coagulopathy caused by hypothermia. We therefore aim
to observe in whole blood at patients core temperature and normotemperature how
mild therapeutic hypothermia affects coagulation and in particular fibrinogen,
in post cardiac arrest patients.
Study objective
We aim to observe in whole blood at patients core temperature and
normotemperature how mild therapeutic hypothermia affects coagulation and in
particular fibrinogen, in post cardiac arrest patients.
Study design
Prospective observational, one centre study.
Study burden and risks
In this study we will observe the effects of mild hypothermia on coagulation
using thromboelastometry. Fore blood samples of 4.5ml will be used for
analysation. Blood sampling will be done from an intravenous catheter witch is
standard ICU procedure in all post cardiac arrest patients and will there for
not add up to patient discomfort. All other parameters are according to routine
ICU protocol and do not cause any extra burden. A potential benefit is the
diagnosis of coagulations disorders that are not detected by classical
coagulation parameters.
De Boelelaan 1117
1081 HV Amsterdam
NL
De Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
In or out of hospital post cardiac arrest patients eligible for hypothermia > 18 years.
Exclusion criteria
< 18 years
Pregnancy
Severe traumatic brain injury
Moribund patients
Use of coumarin derivatives
Pre-existing coagulopathy
Receiving fresh frozen plasma or platelets during hospital admission.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33859.029.10 |