Condition category
Surgery
Date applied
06/12/2013
Date assigned
31/12/2013
Last edited
31/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Joachim Zdolsek

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CEA

Study information

Scientific title

Coagulation effect of induction of anesthesia

Acronym

CEA

Study hypothesis

The primary hypothesis is that the fluid volume redistribution that occurs during induction of anesthesia influences the clotting of the blood.

Ethics approval

Regional ethics committée in Linköping, Dnr 2010/240-31, 11/08/2010

Study design

Prospective controlled randomized open clinical study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

15/12/2013

Overall trial end date

30/06/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

15/12/2013

Recruitment end date

30/06/2015

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Anesthesia and Intensive Care
Linköping
58185
Sweden

Sponsor information

Organisation

Linköping University Hospital (Sweden)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.lio.se/

Funders

Funder type

Government

Funder name

Östergötland City Council (Sweden)

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