A comparison between different strategies to handle anticoagulation during cardiac surgery
| ISRCTN | ISRCTN14201041 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14201041 |
| Secondary identifying numbers | 308-11 |
- Submission date
- 19/12/2014
- Registration date
- 14/01/2015
- Last edited
- 09/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Bleeding after surgery (postoperative bleeding) is one of the most common complications that occur after heart (cardiac) surgery involving cardiopulmonary bypass (CPB). CPB Is a technique where a machine takes over the work of the heart and lungs during surgery, adding oxygen to the blood and circulating it around the body. Postoperative bleeding is, at least in part, due to the patient’s blood being in contact with the artificial surface of the CPB circuit over a long period of time. Contact with this surface causes the blood to clot and so drugs such as heparin are used to stop this clotting from happening. Heparin is given to the patient either as a fixed dose based on the patients weight or by measuring the individual response of the patient to the heparin given. It is not known which strategy is the best in order to best maintains hemostasis (the process that stops the blood from clotting) after the operation. Here, we are going to compare these two strategies.
Who can participate?
All patients that undergo coronary artery bypass grafting or valve replacement.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) are given heparin via the HEPCON Haemostasis Management System Plus device (Medtronic Inc, Minneapolis, Minnesota). After estimating the patients’ blood volume (how much blood they have)and heparin sensitivity (how they react to heparin), the amount of heparin given (dose), the response of the patient to the dose given (heparin dose response) and ACT (amount of time it takes for the blood to clot – activated clotting time) are determined using the HEPCON device. The amount of heparin needed to maintain a desired blood clotting time is estimated every 20 to 30 minutes throughout the surgery. At the end of the CPB, the amount of a drug called protamine, used to neutralise the effects of heparin, is also established using the HEPCON device. Those participants in group 2 (control group) are given a dose of heparin needed to achieve a desired blood clotting time according to their body weight. Heparin monitoring during the surgery is performed by standard ACT. After CPB, the heparin is neutralised by giving protamine. For both groups, blood sampling during and after the operation are taken as are recording of any bleeding and transfusions.
What are the possible benefits and risks of participating?
No immediate benefits but the information gained can be used to improve cardiac operations
Where is the study run from?
Sahlgrenska University Hospital in Gothenburg (Sweden)
When is the study starting and how long is it expected to run for?
January 2011 to April 2013
Who is funding the study?
1. Västra Götaland region (Sweden)
2. Swedish Heart and Lung Foundation (Sweden)
Who is the main contact?
Professor Anders Jeppsson
anders.jeppsson@vgregion.se
Contact information
Scientific
Department of Cardiothoracic Surgery
Sahlgrenska University Hospital
Gothenburg
413 45
Sweden
 ORCID ID |
0000-0003-2356-2295 |
|---|---|
| Phone | +46313427515 |
| anders.jeppsson@vgregion.se |
Study information
| Study design | Prospective randomized open controlled single center study with blinded evaluation |
|---|---|
| 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 participant information sheet |
| Scientific title | Heparin titration vs standard dosing - effects on postoperative hemostasis: a prospective randomized study |
| Study objectives | Anticoagulation management during cardiopulmonary bypass based on heparin and protamine titration preserves the hemostatic capacity better than weight based heparin dosing |
| Ethics approval(s) | Regional Research Ethics Committee in Gothenburg, 18/04/2011, ref: 308-11 |
| Health condition(s) or problem(s) studied | Study anticoagulation strategies during cardiopulmonary bypass. |
| Intervention | 1. Intervention group: HEPCON Haemostasis Management System Plus device (Medtronic Inc, Minneapolis, Minnesota) was used, according to manufacturer’s recommendations. After estimating the patients’ blood volume and individualized heparin sensitivity, the initial bolus heparin dose, heparin dose response and ACT were determined using a six channel cartridge (two channels with heparin concentration 2.5 U/ml, two with heparin concentration 1.5 U/ml and two without added heparin). Since the CPB circuit has already been primed with 10 000 U heparin, only bolus doses of heparin were estimated every 20 to 30 min throughout the surgery, in order to maintain target ACT above 480 s. At the end of the CPB, the protamine dose required for heparin neutralization was also established using the device. 2. Control group: The patients received unfractionated heparin (350 units/kg body weight) in order to achieve target activated clotting time (ACT) of more than 480 seconds. Heparin monitoring intraoperatively was performed by standard ACT (HEMOCHRON Jr. ACT+ [ITC, Edison,NJ]). After CPB, the heparin was reversed by administration of protamine sulphate (1mg protamine/100 units of the initial heparin dose). |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Endogenous thrombin potential in plasma 2 hours after surgery as assessed by calibrated automated thrombogram. |
| Secondary outcome measures | 1. Total heparin and protamine doses during the operation 2. Whole blood clot formation as measured with thromboelastometry 10 min, 2h and 4h after the operation 3. Hemostatic analyses (aPTT, PT, anti-thrombin, fibrinogen, platelet count) 10 min, 2h and 4h after the operation 4. Postoperative bleeding volume the first 12 h, Red blood cell transfusion during hospital stay |
| Overall study start date | 01/01/2011 |
| Completion date | 01/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Patients undergoing elective coronary artery bypass grafting surgery or single valve repair/replacement on cardiopulmonary bypass 2. >18 years old |
| Key exclusion criteria | 1. Acute operation 2. Known bleeding disorder, liver or kidney disease, 3. Previous stroke 4. Treatment with a P2Y12 receptor antagonist <5 days before surgery |
| Date of first enrolment | 25/10/2011 |
| Date of final enrolment | 15/01/2013 |
Locations
Countries of recruitment
- Sweden
Study participating centre
41345
Sweden
Sponsor information
Hospital/treatment centre
Sahlgrenska University Hospital
Gothenburg
41345
Sweden
"ROR" |
https://ror.org/04vgqjj36 |
|---|
Funders
Funder type
Not defined
No information available
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Swedish Heart-Lung Foundation
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/04/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later stage |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/07/2015 | Yes | No | |
| Protocol (other) | 09/02/2023 | No | No |
Editorial Notes
09/02/2023: Protocol and total final enrolment added.
