Hematologic ChangesNCT01958242
Effect of Blood Harvesting and Administration at End of CPB on Coagulation Profile
A study testing Preoperative blood harvesting in people with Hematologic Changes, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Blood transfusions after pediatric heart surgery is a relatively common practice occurring in up to 46% of patients, however its use has been associated with increased morbidity. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hematologic Changes
- What is being tested?
- Preoperative blood harvesting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Dec 2015
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All pediatric patients undergoing heart surgery
Who cannot join
- Unstable patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperative Blood Harvesting and Its Re-administration at the End of Cardio-pulmonary Bypass on the Coagulation Profile in the Pediatric Population Undergoing Open Heart Surgery.
Blood transfusions after pediatric heart surgery is a relatively common practice occurring in up to 46% of patients, however its use has been associated with increased morbidity. In the pediatric population undergoing heart surgery transfusion of homologous blood is usually required due to the mismatch between the priming volume of the cardiopulmonary bypass circuit and the patients own blood volume. Several strategies have been proposed in order to minimize the use of blood products. The effect of pre-operative harvest of fresh whole blood in the adult population has shown a beneficial platelet protective effect, however concerns have been risen that the amount of volume needed in order to sequester a significant amount of platelets would be prohibit ally high in a cardiac surgical patient. Fresh blood harvesting has not been evaluated in the pediatric population.
The purpose of the present study would be to evaluate the safety and efficacy of pre-operative blood harvesting in the pediatric population undergoing open heart surgery. Fresh whole blood will be harvested from the patient prior to the initiation of cardiopulmonary bypass and will be returned to the patient after the discontinuation of CPB prior to the administration of prominent. Parameters that will be evaluated will include, patient characteristic, operative and post-operative parameters, coagulation profiles and the use of postoperative blood products.
Read the detailed description
All pediatric patients undergoing open heart surgery at our institution will be randomized based on the last digit of their identification number (even or odd numbers) to undergo pre-operative whole blood harvesting (PBH). Informed consent will be obtained from the parents at the time of surgical informed consent acquisition.
After scrubbing and draping of the patient the first set of blood samples will be obtained for baseline.
Circuit priming will be performed using plasmalyte , and the prime will be adjusted to have a calculated bypass hematologic 27%, taking into consideration the amount of blood harvested.
Once the patient is connected to the CPB circuit, harvested blood will be taken from the venous line before its passage through the oxygenator, while crystalloids from the circuit will be infused through the arterial line in order to maintain adequate blood pressure. Once the amount of 15cc/kg of blood is harvested, CPB will be initiated and the operation will be carried out in the usual manner. Blood will be kept at room temperature (18°C), gently stirred (not shaken).
At the end of the operation, veno-venous ultrafiltration will be performed, targeting a duration of 10 minutes. The harvested blood will be administered at the end of ultrafiltration in conjunction to the administration of protamine. Blood samples will be obtained at various time points. Complete blood count, coagulation profile (PT/PTT), and platelet function tests will be performed. Pre-operative and operative characteristics will be recorded .
In the intensive care unit, the patient will be continuously followed until his discharge from the hospital and post-operative parameters will be recorded. Blood and blood product administration will be based on our ICU protocol and at the discretion of the attending physician. Generally, blood will be administered to single ventricle patients if their hemoglobin levels will be below 12 mg%, while in the 2 ventricle patients a threshold of 9mg% will be set. Administration of blood products will be performed if there will be signs of clinical bleeding with overt signs of coagulopathy (INR > 2, fibrinogen < 100, platelets < 50,000).
- Conditions
- Hematologic Changes
- Being tested
- Preoperative blood harvesting
- Keywords
- Cardiopulmonary bypass, pediatric, blood products, conservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative blood harvestingOther
There is no true intervention, there is a protocol of preoperative blood harvesting ,and post operative administration of the same blood/
| Study group | Role | What they receive |
|---|---|---|
| Preoperative blood harvesting | No intervention | Not described Receives: Other: Preoperative blood harvesting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in coagulation profile
Coagulation studies will be measured before and after the intervention
Measured: Immediate post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Technical problems.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic ChangesStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Amir, MD, Principal investigator, SCMCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958242
- Sponsor's protocol ID
- 7192
- Status last verified
- Aug 2012
- First submitted
- 17 Apr 2013
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Blood Harvesting and Its Re-administration at the End of Cardio-pulmonary Bypass on the Coagulation Profile in the Pediatric Population Undergoing Open Heart Surgery.
- ClinicalTrials.gov ID
- NCT01958242
- Acronym / sponsor ID
- 7192
- Conditions
- Hematologic Changes
- Keywords
- Cardiopulmonary bypass, pediatric, blood products, conservation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Technical problems.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 9 Oct 2013 (estimated)
- 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.
Blood transfusions after pediatric heart surgery is a relatively common practice occurring in up to 46% of patients, however its use has been associated with increased morbidity. In the pediatric population undergoing heart surgery transfusion of homologous blood is usually required due to the mismatch between the priming volume of the cardiopulmonary bypass circuit and the patients own blood volume. Several strategies have been proposed in order to minimize the use of blood products. The effect of pre-operative harvest of fresh whole blood in the adult population has shown a beneficial platelet protective effect, however concerns have been risen that the amount of volume needed in order to sequester a significant amount of platelets would be prohibit ally high in a cardiac surgical patient. Fresh blood harvesting has not been evaluated in the pediatric population.
The purpose of the present study would be to evaluate the safety and efficacy of pre-operative blood harvesting in the pediatric population undergoing open heart surgery. Fresh whole blood will be harvested from the patient prior to the initiation of cardiopulmonary bypass and will be returned to the patient after the discontinuation of CPB prior to the administration of prominent. Parameters that will be evaluated will include, patient characteristic, operative and post-operative parameters, coagulation profiles and the use of postoperative blood products.
Detailed description
All pediatric patients undergoing open heart surgery at our institution will be randomized based on the last digit of their identification number (even or odd numbers) to undergo pre-operative whole blood harvesting (PBH). Informed consent will be obtained from the parents at the time of surgical informed consent acquisition.
After scrubbing and draping of the patient the first set of blood samples will be obtained for baseline.
Circuit priming will be performed using plasmalyte , and the prime will be adjusted to have a calculated bypass hematologic 27%, taking into consideration the amount of blood harvested.
Once the patient is connected to the CPB circuit, harvested blood will be taken from the venous line before its passage through the oxygenator, while crystalloids from the circuit will be infused through the arterial line in order to maintain adequate blood pressure. Once the amount of 15cc/kg of blood is harvested, CPB will be initiated and the operation will be carried out in the usual manner. Blood will be kept at room temperature (18°C), gently stirred (not shaken).
At the end of the operation, veno-venous ultrafiltration will be performed, targeting a duration of 10 minutes. The harvested blood will be administered at the end of ultrafiltration in conjunction to the administration of protamine. Blood samples will be obtained at various time points. Complete blood count, coagulation profile (PT/PTT), and platelet function tests will be performed. Pre-operative and operative characteristics will be recorded .
In the intensive care unit, the patient will be continuously followed until his discharge from the hospital and post-operative parameters will be recorded. Blood and blood product administration will be based on our ICU protocol and at the discretion of the attending physician. Generally, blood will be administered to single ventricle patients if their hemoglobin levels will be below 12 mg%, while in the 2 ventricle patients a threshold of 9mg% will be set. Administration of blood products will be performed if there will be signs of clinical bleeding with overt signs of coagulopathy (INR > 2, fibrinogen < 100, platelets < 50,000).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative blood harvesting | No intervention | Other: Preoperative blood harvesting |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All pediatric patients undergoing heart surgery
Key exclusion criteria (1 listed)
- Unstable patients
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 |
|---|---|---|
| Preoperative blood harvestingThere is no true intervention, there is a protocol of preoperative blood harvesting ,and post operative administration of the same blood/ | Other | Preoperative blood harvesting |
Primary outcome
Improvement in coagulation profile
Time frame: Immediate post operative
Coagulation studies will be measured before and after the intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
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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.
Gabriel Amir, MD principal investigator
SCMCI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative blood harvesting in people with Hematologic Changes, run by Rabin Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 24 Nov 2015. 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 Israel. 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 was withdrawn before enrolling participants, so there are no results.
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?
Improvement in coagulation profile (time frame: Immediate post operative). 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 24 Nov 2015.