CABG Surgery, Cold Blood Cardioplegia, Coagulation Profile and Platelet FunctionNCT04148404
Hypothermic Versus Normothermic Cardiac Bypass in Patients Undergoing CABG Surgery, Effect on Coagulation; Randomized Controlled Trial
A study testing Normothermic group in people with CABG Surgery, Cold Blood Cardioplegia, Coagulation Profile and Platelet Function, run by Cairo University at 1 site in Egypt.
Trial summary
On-pump CABG surgery deleteriously affects hematological and coagulation profiles of patients and this effect was accentuated by the use of cold bypass. PO altered platelet may count and function and prolonged clotting times correlates with amount of daily PO blood wound drainage and number of blood products units… Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- CABG Surgery, Cold Blood Cardioplegia, Coagulation Profile and Platelet Function
- What is being tested?
- Normothermic group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 9 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ischemic heart disease patients
- Both genders
- Aged 50 - 65 years
- Assigned for first-time, elective and isolated on-pump CABG surgery.
Who cannot join
- Pre-existing coagulopathy
- Hemostasis disorders,
- Anemia,
- Redo or emergency CABG, re-exploration for surgical-cause PO bleeding, other associated pathologies, hepatic or renal impairment and/or maintenance on antiplatelet therapy during the last 10 days prior to surgery
Trial locations and contacts
1 site in 1 country.
About this study
On-pump CABG surgery deleteriously affects hematological and coagulation profiles of patients and this effect was accentuated by the use of cold bypass. PO altered platelet may count and function and prolonged clotting times correlates with amount of daily PO blood wound drainage and number of blood products units used, but prolonged aPTT is the best predictor for these events.
Read the detailed description
Background: The use of cardiopulmonary bypass during cardiac surgery negatively affects the coagulation system. Hypothermia is also known to inhibit the coagulation profile. The aim of the study is to assess and compare the early postoperative (PO) haematological and coagulation profile of patients undergoing coronary artery bypass graft (CABG) surgery with Hypothermic (HT) versus normothermic (NT) bypass Methods: eighty-six patients were divided into two equal groups: NT group included patients received warm bypass and using warm blood cardioplegia from bypass and HT group included patients received cold bypass and using cold cardioplegia given by the anaesthesiologist. PO monitoring included the activated clotting time (ACT) prior to wound closure and 2-hr changes in the haemoglobin concentration (Hb), platelet count (PC), ADP-induced platelet aggregation (IPA), INR in relation to preoperative profile and amount of PO daily blood loss and number of transfused blood units. The primary outcome was the PO alternations in the coagulation and haematological profile. The secondary outcome was the amount of PO daily bleeding, number of transfused blood units and incidence of re-opening surgery due to bleeding.
- Being tested
- Normothermic group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normothermic groupProcedure or surgery
Also called Hypothermic group
- Normothermic group (NT group) included patients will undergo CABG under warm bypass using warm blood cardioplegia (Normothermic CBP).
- Hypothermic group (HT group) included patients will undergo CABG under cold bypass using cold blood cardioplegia (Hypothermic CBP).
| Study group | Role | What they receive |
|---|---|---|
| Group NT | Active comparator | 1.Normothermic group (NT group) included patients will undergo CABG under warm bypass using warm blood cardioplegia (Normothermic CBP). Receives: Procedure: Normothermic group |
| Group HT | Active comparator | 2.Hypothermic group (HT group) included patients will undergo CABG under cold bypass using cold blood cardioplegia (Hypothermic CBP). Receives: Procedure: Normothermic group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative alternations in the coagulation and haematological profile
Postoperative alternations in the coagulation and haematological profile
Measured: One day Postoperative
Secondary outcomes (3)
Amount of PO daily bleeding
Amount of PO daily bleeding
Measured: One day Postoperative
Number of transfused blood units
Number of transfused blood units
Measured: One day Postoperative
Incidence of re-opening surgery due to bleeding
Incidence of re-opening surgery due to bleeding
Measured: 24 hours Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start1 Feb 2019
- Primary completion1 Jun 2019
- Study completion9 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CABG Surgery, Cold Blood Cardioplegia, Coagulation Profile and Platelet FunctionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hypothermia may alter coagulation profile of patients undergoing CABG surgery; thus, affecting patients' outcome.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148404
- Sponsor's protocol ID
- Hypothermic vs normothermic
- Status last verified
- Oct 2019
- First submitted
- 28 Oct 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Till ending our work
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypothermic Versus Normothermic Cardiac Bypass in Patients Undergoing CABG Surgery, Effect on Coagulation; Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04148404
- Acronym / sponsor ID
- Hypothermic vs normothermic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 9 Jun 2019 (actual)
- First posted
- 1 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
On-pump CABG surgery deleteriously affects hematological and coagulation profiles of patients and this effect was accentuated by the use of cold bypass. PO altered platelet may count and function and prolonged clotting times correlates with amount of daily PO blood wound drainage and number of blood products units used, but prolonged aPTT is the best predictor for these events.
Detailed description
Background: The use of cardiopulmonary bypass during cardiac surgery negatively affects the coagulation system. Hypothermia is also known to inhibit the coagulation profile. The aim of the study is to assess and compare the early postoperative (PO) haematological and coagulation profile of patients undergoing coronary artery bypass graft (CABG) surgery with Hypothermic (HT) versus normothermic (NT) bypass Methods: eighty-six patients were divided into two equal groups: NT group included patients received warm bypass and using warm blood cardioplegia from bypass and HT group included patients received cold bypass and using cold cardioplegia given by the anaesthesiologist. PO monitoring included the activated clotting time (ACT) prior to wound closure and 2-hr changes in the haemoglobin concentration (Hb), platelet count (PC), ADP-induced platelet aggregation (IPA), INR in relation to preoperative profile and amount of PO daily blood loss and number of transfused blood units. The primary outcome was the PO alternations in the coagulation and haematological profile. The secondary outcome was the amount of PO daily bleeding, number of transfused blood units and incidence of re-opening surgery due to bleeding.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Hypothermia may alter coagulation profile of patients undergoing CABG surgery; thus, affecting patients' outcome.
| Arm | Type | Receives |
|---|---|---|
| Group NT | Active comparator | Procedure: Normothermic group1.Normothermic group (NT group) included patients will undergo CABG under warm bypass using warm blood cardioplegia (Normothermic CBP). |
| Group HT | Active comparator | Procedure: Normothermic group2.Hypothermic group (HT group) included patients will undergo CABG under cold bypass using cold blood cardioplegia (Hypothermic CBP). |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic heart disease patients
- Both genders
- Aged 50 - 65 years
- Assigned for first-time, elective and isolated on-pump CABG surgery.
Key exclusion criteria (4 listed)
- Pre-existing coagulopathy
- Hemostasis disorders,
- Anemia,
- Redo or emergency CABG, re-exploration for surgical-cause PO bleeding, other associated pathologies, hepatic or renal impairment and/or maintenance on antiplatelet therapy during the last 10 days prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normothermic groupAlso: Hypothermic group1. Normothermic group (NT group) included patients will undergo CABG under warm bypass using warm blood cardioplegia (Normothermic CBP). 2. Hypothermic group (HT group) included patients will undergo CABG under cold bypass using cold blood cardioplegia (Hypothermic CBP). | Procedure or surgery | Group HT, Group NT |
Primary outcome
Postoperative alternations in the coagulation and haematological profile
Time frame: One day Postoperative
Postoperative alternations in the coagulation and haematological profile
3 secondary outcomes
Amount of PO daily bleeding
Time frame: One day Postoperative
Number of transfused blood units
Time frame: One day Postoperative
Incidence of re-opening surgery due to bleeding
Time frame: 24 hours Postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Individual participant dataSharing planned: Undecided. Till ending our work
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normothermic group in people with CABG Surgery, Cold Blood Cardioplegia, Coagulation Profile and Platelet Function, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative alternations in the coagulation and haematological profile (time frame: One day Postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.