ISRCTN - ISRCTN62203940: Hypercoagulation effect evaluation and deep vein thrombosis preventions after laparoscopic surgery.

Plain English Summary

Background and study aims
Venous thromboembolism (VTE) is a serious, potentially fatal, medical condition where people develop a blood clot in a vein. People who have just had major surgery are at particular risk of VTE; between 20-30% of VTE patients have just had general surgery. About 5.5% of VTE patients have undergone laparoscopic fundoplication, a “keyhole” surgery for treating gastro-oesophageal reflux disease. Here, we want to test whether treating patients with Bemiparin (Zibor) before patients have their laparoscopic fundoplication surgery reduces the risk of deep vein thrombosis (DVT), a blood clot in a leg vein. We will be investigating two different treatment regimens to see which one works best.

Who can participate?
Adult patients between 18-75 years undergoing laparoscopic fundoplication surgery.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 receive one dose (2500 TV 0,2 ml.) of Bemiparin and intraoperative intermittent pneumatic compression (IPC – a therapy whereby an inflatable device squeezes fluids, such as blood, out of the area where it is applied) one hour before their operation. Those in group 2 receive 3 doses of Bemiparin, one 12 hours before the operation, one 6 hours after the operation and a final dose 30 hours after the operation. IPC is also applied during the surgery. After the operation, the blood is tested for certain components (markers) that would suggest a blood clot is forming (thrombogenesis) and other components that would suggest that the blood is not able to clot (hypocoagulation). These are measured 1 hour before, during, just after and then 2 days after the operation. Deep vein imaging methods are also used to check for DVT before the operation, 2 days afterwards and finally 28 days after the surgery.

What are the possible benefits and risks of participating?
There are no additional risks to taking part in the study.

Where is the study run from?
The Hospital of Lithuanian University of Health Sciences (LUHS) (Lithuania)

When is the study starting and how long is it expected to run for?
January 2014 to January 2017

Who is funding the study?
The Lithuanian University of Health Sciences (LUHS) (Lithuania)

Who is the main contact?
Dr. Indre Zostautiene
indrajoss@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Indre Zostautiene

ORCID ID

Contact details

S. Ciurlionienes-Kymantaites str. 7
Kaunas
LT-46320
Lithuania
-
indrajoss@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Hypercoagulation effect evaluation and deep vein thrombosis preventions after laparoscopic surgery: a prospective randomized double blinded trial.

Acronym

N/A

Study hypothesis

A combination of one dose low-molecular-weight heparin (LMWH) 1h before laparoscopic surgery with intraoperative intermittent pneumatic compression (IPC) causes better hypocoagulation effect that LMWH administered 12h before surgery with intraoperative IPC.

Ethics approval

Regional Biomedical Research Ethics Committees in Lithuania: in Kaunas region (based at the Lithuanian University of Health Sciences), 08/10/2014, ref. Nr. BE-2-13.

Study design

Prospective randomized double blinded trial.

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

Patients with hiautus hernia diagnosis and condition after laparoscopic fundoplications.
The study domain is to evaluate the hypocoagulation effect and rate of deep vein thrombosis complications of intermittent pneumatic compression (IPC) combination of low molecular weight heparin (LMWH) after laparoscopic fundoplication

Intervention

The participants were randomly allocated into one of two groups:
Group 1 received subcutaneous 2500 TV 0,2 ml LMWH Bemiparin (Zibor) - one dose (1h before the operation)
Group 2 received three doses of 2500 TV 0,2 ml LMWH Bemiparin (Zibor) - (12h before the operation, 6h and 30h after the operation).

Blood sampling:
Venous blood samples were taken (obtained) from the forearm vein four times:
1. 1h. before the operation (before LMWH injection)
2. 1h after the introduction of the laparoscope
3. After extubation
4. 2 days after the operation

Imaging methods:
1. Duplex examination - before the operation, two days after the operation and 28 days after the operation
2. Spiral CT venography two days after the operation.

Intervention type

Phase

Not Applicable

Drug names

Primary outcome measure

1. F1+2 and TAT concentrations in plasma samples were measured by solid phase sandwich ELISA method (Enzygnost® F1+2 and Enzygnost® TAT microenzyme immunoassay, Dade Behring, Germany).
2. fTFPI was performed by an ELISA technique (Diagnostika Stago, France) according to the manufacturers instructions.
3. Thromboelastograma - TEG measures the physical properties of the clot in whole blood via a pin suspended in a cup (heated to 37C) from a torsion wire connected with a mechanicalelectrical transducer; koalin is used as activator.

Secondary outcome measures

Ultrasound examination - Toshiba Aplio SSA 770A - compression ultrasound (B-mode imaging only), duplex ultrasound (B-mode imaging and Doppler waveform analysis), and color Doppler imaging alone. Different lower extremity veins are best evaluated with different techniques: compression ultrasound is typically performed on the proximal deep veins - the common femoral, femoral, and popliteal veins, whereas a combination of duplex ultrasound and color Doppler imaging is more often used to interrogate the calf and iliac veins.
Spiral CT venography - GE Light Speed Pro (320 slice) - using 150 mL of IV contrast -
4 mL/sec, with a delay three minutes after the start of injection, 5-mm thick
axial CT venograms are acquired from the ankles to the mid abdomen.

Overall trial start date

01/01/2014

Overall trial end date

01/01/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients undergoing elective laparoscopic fundoplications because of gastroesophagial reflux disease, caused by hiatus hernia.
2. The patients in the two groups are similar in terms of age (18 - 75 years), weight, height, gender, duration of surgery and ASA score.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100-150

Participant exclusion criteria

1. Patients with coagulopathies disorders
2. Usage of prescription drug modifying cardiovascular response
3. Participants with systemics nervous system disease
4. Pregnant women
5. Patients, who refused to participate in the study

Recruitment start date

01/01/2014

Recruitment end date

01/01/2017

Locations

Countries of recruitment

Lithuania

Trial participating centre

S. Ciurlionienes-Kymantaites str. 7
Kaunas
LT-46320
Lithuania

Sponsor information

Organisation

The Lithuanian University of Health Sciences (LUHS) (Lithuania)

Sponsor details

Eiveniu str. 2
Kaunas
LT-50009
Lithuania
-
rastine@kaunoklinikos.lt

Sponsor type

University/education

Website

Funders

Funder type