HeparinPhase 4LBWHNCT03113708
The Effect of Heparinization Due to LBW
A Phase 4 study testing Heparin Sodium in people with Heparin and Heparin Overdose, run by Adiyaman University Research Hospital.
Trial summary
High dose heparin regimens are required in cardiac surgery under cardiopulmonary bypass (CPB) and this may increase postoperative bleeding. The aim of this study is to evaluate the effect of heparin dose calculated according to lean body weight on intraoperative and postoperative bleeding. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heparin, Heparin Overdose, Bleeding
- What is being tested?
- Heparin Sodium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2017to 20 Jun 2017
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old, first time valve surgeries which was done on-pump.
Who cannot join
- Revision valve surgeries
- Patients with coagulation deficits
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Heparinization Due to LBW in Cardiac Surgery
High dose heparin regimens are required in cardiac surgery under cardiopulmonary bypass (CPB) and this may increase postoperative bleeding. The aim of this study is to evaluate the effect of heparin dose calculated according to lean body weight on intraoperative and postoperative bleeding.
Read the detailed description
Patients with preoperative demographic data such as age, gender, body weight, height, and additional disease, medications, previous surgery, preoperative Htc / Hb values were recorded in the operation room without medical premedication. Standard anesthesia induction was performed after arterial cannulation and peripheral venous route. Patients were randomly divided into two groups: 400 IU heparin / kg (Group I) and 400 IU heparin / kg (Group II) according to actual body weight and lean body weight respectively before CPB. Before and after heparin administration, CPB entry and ACT (Activated Clotting Time) values were counted every 30 minutes, after CPB exit and protamine. In both groups, supplemental heparin was administered when there was a failure to reach the pre-CPB target ACT value of 400 sec. Hemodynamic data and transfusion requirements were recorded during the operation. Patient's intraoperative CPB and crossover times, postoperative drainage volume and blood transfusion requirement were recorded.
- Conditions
- Heparin, Heparin Overdose, Bleeding
- Being tested
- Heparin Sodium
- Keywords
- heparin, heparin antagonists, cardiac surgery, active clotting time
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin SodiumDrug
Heparinisation 2-4 mg/kg will be done according to actual body weight or lean body weight.
| Study group | Role | What they receive |
|---|---|---|
| Heparinisation,actual body weight | Sham comparator | In 'Heparinisation,actual body weight' group , heparin sodium; will be done according to actual body weight and ACT will be recorded prior to CPB. Before coming out CPB, protamine will be done according to heparin dose. And then ACT will be recorded. Receives: Drug: Heparin Sodium |
| Heparinisation, lean body weight | Experimental | In 'Heparinisation, lean body weight' group heparin sodium will be done according to lean body weight and ACT will be recorded prior to CPB. Before coming out CPB, protamine will be done according to heparin dose. And then ACT will be recorded. Receives: Drug: Heparin Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACT
Activated clotting time
Measured: Through study completion, an average of 48 hours
Secondary outcomes (1)
Bleeding
Postoperative bleeding
Measured: Through study completion, an average of 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start30 Apr 2017 (estimated)
- Primary completion20 May 2017 (estimated)
- Study completion20 Jun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeparinStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ülkü Sabuncu, Adiyaman University Research Hospital
- Investigators
- Ulku Sabuncu, Principal investigator, Yuksek Ihtisas Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113708
- Sponsor's protocol ID
- LBW heparin
- Acronym
- LBWH
- Status last verified
- Apr 2017
- First submitted
- 25 Mar 2017
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Heparinization Due to LBW in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03113708
- Acronym / sponsor ID
- LBWH / LBW heparin
- Conditions
- Heparin, Heparin Overdose, Bleeding
- Keywords
- heparin, heparin antagonists, cardiac surgery, active clotting time
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 30 Apr 2017 (estimated)
- Primary completion
- 20 May 2017 (estimated)
- Study completion
- 20 Jun 2017 (estimated)
- First posted
- 13 Apr 2017 (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.
High dose heparin regimens are required in cardiac surgery under cardiopulmonary bypass (CPB) and this may increase postoperative bleeding. The aim of this study is to evaluate the effect of heparin dose calculated according to lean body weight on intraoperative and postoperative bleeding.
Detailed description
Patients with preoperative demographic data such as age, gender, body weight, height, and additional disease, medications, previous surgery, preoperative Htc / Hb values were recorded in the operation room without medical premedication. Standard anesthesia induction was performed after arterial cannulation and peripheral venous route. Patients were randomly divided into two groups: 400 IU heparin / kg (Group I) and 400 IU heparin / kg (Group II) according to actual body weight and lean body weight respectively before CPB. Before and after heparin administration, CPB entry and ACT (Activated Clotting Time) values were counted every 30 minutes, after CPB exit and protamine. In both groups, supplemental heparin was administered when there was a failure to reach the pre-CPB target ACT value of 400 sec. Hemodynamic data and transfusion requirements were recorded during the operation. Patient's intraoperative CPB and crossover times, postoperative drainage volume and blood transfusion requirement were recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heparinisation,actual body weight | Sham comparator | Drug: Heparin SodiumIn 'Heparinisation,actual body weight' group , heparin sodium; will be done according to actual body weight and ACT will be recorded prior to CPB. Before coming out CPB, protamine will be done according to heparin dose. And then ACT will be recorded. |
| Heparinisation, lean body weight | Experimental | Drug: Heparin SodiumIn 'Heparinisation, lean body weight' group heparin sodium will be done according to lean body weight and ACT will be recorded prior to CPB. Before coming out CPB, protamine will be done according to heparin dose. And then ACT will be recorded. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-65 years old, first time valve surgeries which was done on-pump.
Key exclusion criteria (2 listed)
- Revision valve surgeries
- Patients with coagulation deficits
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 |
|---|---|---|
| Heparin SodiumHeparinisation 2-4 mg/kg will be done according to actual body weight or lean body weight. | Drug | Heparinisation, lean body weight, Heparinisation,actual body weight |
Primary outcome
ACT
Time frame: Through study completion, an average of 48 hours
Activated clotting time
1 secondary outcome
Bleeding
Time frame: Through study completion, an average of 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Ulku Sabuncu principal investigator
Yuksek Ihtisas Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Heparin Sodium in people with Heparin and Heparin Overdose, run by Adiyaman University Research Hospital.
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 2 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: status not confirmed, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulku Sabuncu, M.D. (+90 533 708 5212, sabuncuulku@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACT (time frame: Through study completion, an average of 48 hours). 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 14 Apr 2017.