Coagulation Effect of Anesthesia

ISRCTN	ISRCTN15932456
DOI	https://doi.org/10.1186/ISRCTN15932456
Secondary identifying numbers	CEA

Submission date: 06/12/2013
Registration date: 31/12/2013
Last edited: 01/09/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
During surgery and fluid therapy, blood clotting changes. Fluid therapy expands and dilutes the plasma (a component of blood) and different constituents of the plasma. Fluid therapy may be necessary in situations of blood loss, dehydration prior to surgery or anesthetic technique used during the surgery. The plasma dilution can affect the clotting of the blood in several aspects. When anesthesia is given, there is a redistribution of fluid in the body regardless of fluid is administered or not. In earlier studies we have found that only by giving colloids (substances that are dispersed throughout a liquid) at the start of anesthesia, the blood clotting is changed. However, we did not see any major differences between different colloids. The differences were found with the dilution, than with any other factor. In this study we wish to study the effects of induction of anesthesia. Further we wish to study if there is a difference in the clotting of the blood if fluid therapy is given or not, during the induction of the anesthesia.

Who can participate?
Patients over 18 years of age who have had their gall bladder removed can participate in the study.

What does the study involve?
Patients are randomly allocated to receive fluid therapy or not. Those patients allocated to fluid therapy will receive fluid infusion during the induction of anesthesia. Others will not receive fluid therapy unless required. Blood samples will be taken before and after start of anesthesia to study blood clotting.

What are the possible benefits and risks of participating?
If unexpected clotting defects are found these can be dealt with early, before major bleeding occurs.

Where is the study run from?
The study will take place at the operation ward at Norrköping Hospital, Sweden.

When is the study starting and how long is it expected to run for?
The study starts in December 2013 and is expected to finish in June 2015.

Who is funding the study?
The study is funded by the Östergötland County Council, Sweden.

Who is the main contact?
Dr Joachim Zdolsek
joachim.zdolsek@lio.se

Contact information

Dr Joachim Zdolsek
Scientific

Department of Anesthesia and Intensive Care
Linköping University Hospital
Linköping
58185
Sweden

Study information

Study design	Prospective controlled randomized open clinical study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Coagulation effect of induction of anesthesia
Study acronym	CEA
Study objectives	The primary hypothesis is that the fluid volume redistribution that occurs during induction of anesthesia influences the clotting of the blood.
Ethics approval(s)	Regional ethics committée in Linköping, Dnr 2010/240-31, 11/08/2010
Health condition(s) or problem(s) studied	Changes in coagulation during induction of anesthesia in elective surgery: cholecystectomy
Intervention	40 patients subjected to cholecystectomy during general anesthesia are asked to participate in the study, during preanesthetic evaluation. 40 envelopes are placed in a box. The envelope picked decides to which group the patient will be randomized. One group (20 patients) will receive fluid infusion during induction of anesthesia. In the other group (20 patients) fluid will as far as possible be avoided. In case of hypotension, these patients will first receive ephedrine and Trendelenburg tilt. If this does not help, fluid infusion is started.
Intervention type	Procedure/Surgery
Primary outcome measure	Qualitative analysis of blood clotting by rotational trombelastometry (ROTEM). Blood samples are collected prior to anesthesia and 15 minutes after induction of anesthesia.
Secondary outcome measures	All other clotting tests performed before and 15 minutes after induction of anesthesia: 1. Hemoglobin (Hgb) 2. Albumin 3. Thrombin antthrombin complex (TAT) 4. D-dimer 5. Soluble P-selectin 6. Activated partial thrombin time (APTT) 7. Prothrombin time (PT) and international normalized ratio (INR) 8. Platelets
Overall study start date	15/12/2013
Completion date	30/06/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	40
Key inclusion criteria	1. Patients over the age of 18, belonging to American Society of Anaesthesiologists (ASA) physical status classification score groups I and II 2. Patients operated with cholecystectomy 3. Patients signing informed consent after oral and written information
Key exclusion criteria	1. Regional anesthesia 2. Age less than 18 years 3. Pregnancy 4. ASA group III and IV 5. Cardiac disease 6. Known kidney failure (creatinine >170) 7. Rheumatoid arthritis 8. Treatment with anticoagulants
Date of first enrolment	15/12/2013
Date of final enrolment	30/06/2015

Locations

Countries of recruitment

Sweden

Study participating centre

Department of Anesthesia and Intensive Care

Linköping
58185
Sweden

Sponsor information

Linköping University Hospital (Sweden)
Hospital/treatment centre

c/o Joachim Zdolsek
Department of Anesthesia and Intensive Care
Linköping
58185
Sweden

Website	http://www.lio.se/
"ROR"	https://ror.org/05h1aye87

Funders

Funder type

Government

Östergötland City Council (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

01/09/2020: No publications found.