Blood Platelet DisorderNCT03762707
Correlation Between Platelet Function Analyzer-100 Testing and Bleeding Events After Percutaneous Kidney Biopsy
An observational study of Blood Platelet Disorder and Hemorrhage, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial summary
Kidney biopsy represents the criterion standard to obtain information on diagnosis and prognosis of renal dysfunctions . Many patients with kidney disease have a predisposition to bleed, especially when they undergo an invasive procedure such as renal biopsy. The predominant factor is abnormal platelet function. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Blood Platelet Disorder, Hemorrhage, Kidney Diseases
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jun 2019to 1 Sep 2019
- Phase
- Observational
- 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 85 years
- All sexes
- Adult, Older adult
Study population: The present cohort includes 250 all adult patients who underwent percutaneous renal biopsy of native kidney in the Department of Emergency and Organ Transplantation, the University of Bari, Italy, from January 2017 to December 2018. Transplant kidney biopsies were excluded from this study.
Who may be able to join
- all patients undergoing standard percutaneous renal biopsy performed in our Unit
Who cannot join
- contraindication to standard percutaneous renal biopsy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOUConsorziale Policlinico Di Bari
Bari, 70124
Loreto Gesualdo, Prof, +390805594040, trialnefrobari@gmail.com
About this study
Kidney biopsy represents the criterion standard to obtain information on diagnosis and prognosis of renal dysfunctions . Many patients with kidney disease have a predisposition to bleed, especially when they undergo an invasive procedure such as renal biopsy. The predominant factor is abnormal platelet function. Therefore, the aim of this study is to evaluate whether the platelet function analyzer (PFA-100), a very reliable test to investigate primary hemostasis, can be useful in predicting the risk of bleeding complications in patients undergoing renal biopsy.
Read the detailed description
Kidney biopsy frequently is used to investigate the cause of suspected renal parenchymal disease. Although kidney biopsy may provide important diagnostic information and guide therapeutic decisions, the benefits must be weighed against the potential harms of biopsy. Bleeding is one of the most feared risks from a renal biopsy.
The technique has significantly evolved because of the introduction of real-time ultrasound guidance and use an automated spring-loaded biopsy device. As a consequence, the general safety and complication rate of the procedure has substantially improved. Post biopsy bleeding (hematoma and hematuria) is the primary complication of renal biopsies. However, most of the perirenal hematomas are minor and without clinical significance, and major complications are infrequent.
To minimize bleeding risk, we used the following prebiopsy parameters as a guide: prothrombin time (PT), activated partial thromboplastin time (aPTT), platelet count, age, sex, glomerular filtration rate and blood pressure. Antiaggregant and anticoagulant were stopped for 7 -10 days before biopsy. The Ivy bleeding time (BT) was performed.
Although an specific lancet is used to deliver a relatively standardized incision on the patient's forearm, the Ivy bleeding time technique is patient and operator-dependent. Skin thickness varies not only with age, but also with a number of other factors, such as nutritional status. For these reasons was developed the platelet function analyzer, PFA-100. This test assess primary haemostasis in vitro using citrated whole blood. The device simulates in vivo haemostatic plug formation under high shear flow by measuring the time required to occlude (closure time, CT) a collagen/epinephrine (Coll-EPI) or collagen/ADP (Coll-ADP)-coated aperture inserted in a plastic membrane. PFA-100 is more sensitive than BT to abnormalities of primary haemostasis.
The objective of this study is to demonstrate whether an abnormal PFA-100 can predict bleeding events after percutaneous kidney biopsy.
The present cohort includes 250 all adult patients who underwent percutaneous renal biopsy of native kidney in the Department of Emergency and Organ Transplantation, the University of Bari, Italy, from January 2017 to December 2018. Transplant kidney biopsies were excluded from this study. Three experienced nephrologists performed all the biopsies.
Participation included clinical data collection, serial blood and urine sampling before and after the procedure. Kidney ultrasound was performed in all patients before the procedure.
The following data were collected for all patients:
- Variables pre-biopsy:
- baseline demographics (age, gender);
- indication for renal biopsy [urinary abnormalities (i.e., proteinuria and haematuria), and/or recurrent macrohaematuria and/or nephrotic syndrome and/or nephritic syndrome and/or alteration of renal function and/or acute renal failure];
- baseline systolic and diastolic blood pressure;
- which kidney was biopsied;
- baseline serum creatinine, azotaemia and glomerular filtration rate;
- baseline haemoglobin and platelet count;
- baseline coagulation parameters (prothrombin time, partial thromboplastin time, bleeding time);
- baseline urinary protein excretion;
- body mass index.
- Variables during-biopsy:
- administration of DDAVP;
- number of passes;
- number of renal biopsy samples;
- the position of the patient during kidney biopsy [prone position or supine anterolateral position (SALP)];
- Variables post-biopsy:
- hemoglobin;
- post-biopsy bleeding complications (gross hematuria, hematoma);
- if was necessary transfusion of blood products or an invasive procedure (angiography and arterial embolization or surgery).
Evaluation of kidneys conditions were performed by ultrasound before the procedure in all patients. Longitudinal and transverse size, corticomedullary differentiation shape, location and related structures of the kidney were assessed using ultrasound and blood flow of the kidneys were assessed using a color-flow Doppler signal.
All biopsies were performed using real-time ultrasound-fixed guidance by a nephrologist with assistance from an expert in renal ultrasonography. A 16-gauge automated spring-loaded gun was used for the biopsy. A pathologist promptly examined the biopsy specimen under alight microscope to confirm that adequate renal tissue was available for further pathological evaluations. 1-deamino-8-D-arginine vasopressin (DDAVP) was administered to all patients who had not contraindication.
After the procedure, patients were invited to rest in bed on their backs for a 24-hour observation time. Meantime, clinical evaluation (gross haematuria, flank pain, hypotension) was performed to identify a bleeding complications. Ultrasound evaluation was performed for all patients after 24 hours from percutaneous renal biopsy to exclude a presence of complication, as hematoma and arteriovenous fistula Post biopsy bleeding complications were categorized as either minor or major. Minor bleeding complications included gross haematuria and/or subcapsular perinephric hematoma (<5cm diameter) that spontaneously resolved without need for further intervention. Major complications were defined as those that required an intervention for resolution, either the transfusion of blood products or an invasive procedure (angiography, surgery), and those that led to acute renal obstruction or failure, septicaemia, or death. The size of post biopsy hematoma (surface area) was defined as the product of the longest and the shortest diameters on the two-dimensional sonographic pictures.
- Conditions
- Blood Platelet Disorder, Hemorrhage, Kidney Diseases
- Keywords
- Platelet Function Analyser-100 (PFA-100), Kidney biopsy, Bleeding Complications
- Medical subject headings
- Blood Platelet Disorders, Hemorrhage, Kidney Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding After Kidney Biopsy
Gross haematuria and/or subcapsular perinephric hematoma at ultrasound evaluation. Need for transfusion of blood products or an invasive procedure (angiography, surgery).
Measured: 24 hours
Secondary outcomes (1)
Hemoglobin After Kidney Biopsy
Anemization After Kidney Biopsy
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start13 Jun 2019
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Platelet DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Carlo Manno, Dott. Francesco Pesce, Dott. Michele Rossini, Dott. Vincenzo Di Leo
- Responsible party
- Principal investigator, Loreto GESUALDO, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762707
- Sponsor's protocol ID
- LGPFA100
- Status last verified
- Jun 2019
- First submitted
- 2 Dec 2018
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Platelet Function Analyzer-100 Testing and Bleeding Events After Percutaneous Kidney Biopsy
- ClinicalTrials.gov ID
- NCT03762707
- Acronym / sponsor ID
- LGPFA100
- Conditions
- Blood Platelet Disorder, Hemorrhage, Kidney Diseases
- Keywords
- Platelet Function Analyser-100 (PFA-100), Kidney biopsy, Bleeding Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Collaborators
- Prof. Carlo Manno, Dott. Francesco Pesce, Dott. Michele Rossini, Dott. Vincenzo Di Leo
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 4 Dec 2018 (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.
Kidney biopsy represents the criterion standard to obtain information on diagnosis and prognosis of renal dysfunctions . Many patients with kidney disease have a predisposition to bleed, especially when they undergo an invasive procedure such as renal biopsy. The predominant factor is abnormal platelet function. Therefore, the aim of this study is to evaluate whether the platelet function analyzer (PFA-100), a very reliable test to investigate primary hemostasis, can be useful in predicting the risk of bleeding complications in patients undergoing renal biopsy.
Detailed description
Kidney biopsy frequently is used to investigate the cause of suspected renal parenchymal disease. Although kidney biopsy may provide important diagnostic information and guide therapeutic decisions, the benefits must be weighed against the potential harms of biopsy. Bleeding is one of the most feared risks from a renal biopsy.
The technique has significantly evolved because of the introduction of real-time ultrasound guidance and use an automated spring-loaded biopsy device. As a consequence, the general safety and complication rate of the procedure has substantially improved. Post biopsy bleeding (hematoma and hematuria) is the primary complication of renal biopsies. However, most of the perirenal hematomas are minor and without clinical significance, and major complications are infrequent.
To minimize bleeding risk, we used the following prebiopsy parameters as a guide: prothrombin time (PT), activated partial thromboplastin time (aPTT), platelet count, age, sex, glomerular filtration rate and blood pressure. Antiaggregant and anticoagulant were stopped for 7 -10 days before biopsy. The Ivy bleeding time (BT) was performed.
Although an specific lancet is used to deliver a relatively standardized incision on the patient's forearm, the Ivy bleeding time technique is patient and operator-dependent. Skin thickness varies not only with age, but also with a number of other factors, such as nutritional status. For these reasons was developed the platelet function analyzer, PFA-100. This test assess primary haemostasis in vitro using citrated whole blood. The device simulates in vivo haemostatic plug formation under high shear flow by measuring the time required to occlude (closure time, CT) a collagen/epinephrine (Coll-EPI) or collagen/ADP (Coll-ADP)-coated aperture inserted in a plastic membrane. PFA-100 is more sensitive than BT to abnormalities of primary haemostasis.
The objective of this study is to demonstrate whether an abnormal PFA-100 can predict bleeding events after percutaneous kidney biopsy.
The present cohort includes 250 all adult patients who underwent percutaneous renal biopsy of native kidney in the Department of Emergency and Organ Transplantation, the University of Bari, Italy, from January 2017 to December 2018. Transplant kidney biopsies were excluded from this study. Three experienced nephrologists performed all the biopsies.
Participation included clinical data collection, serial blood and urine sampling before and after the procedure. Kidney ultrasound was performed in all patients before the procedure.
The following data were collected for all patients:
- Variables pre-biopsy:
- baseline demographics (age, gender);
- indication for renal biopsy [urinary abnormalities (i.e., proteinuria and haematuria), and/or recurrent macrohaematuria and/or nephrotic syndrome and/or nephritic syndrome and/or alteration of renal function and/or acute renal failure];
- baseline systolic and diastolic blood pressure;
- which kidney was biopsied;
- baseline serum creatinine, azotaemia and glomerular filtration rate;
- baseline haemoglobin and platelet count;
- baseline coagulation parameters (prothrombin time, partial thromboplastin time, bleeding time);
- baseline urinary protein excretion;
- body mass index.
- Variables during-biopsy:
- administration of DDAVP;
- number of passes;
- number of renal biopsy samples;
- the position of the patient during kidney biopsy [prone position or supine anterolateral position (SALP)];
- Variables post-biopsy:
- hemoglobin;
- post-biopsy bleeding complications (gross hematuria, hematoma);
- if was necessary transfusion of blood products or an invasive procedure (angiography and arterial embolization or surgery).
Evaluation of kidneys conditions were performed by ultrasound before the procedure in all patients. Longitudinal and transverse size, corticomedullary differentiation shape, location and related structures of the kidney were assessed using ultrasound and blood flow of the kidneys were assessed using a color-flow Doppler signal.
All biopsies were performed using real-time ultrasound-fixed guidance by a nephrologist with assistance from an expert in renal ultrasonography. A 16-gauge automated spring-loaded gun was used for the biopsy. A pathologist promptly examined the biopsy specimen under alight microscope to confirm that adequate renal tissue was available for further pathological evaluations. 1-deamino-8-D-arginine vasopressin (DDAVP) was administered to all patients who had not contraindication.
After the procedure, patients were invited to rest in bed on their backs for a 24-hour observation time. Meantime, clinical evaluation (gross haematuria, flank pain, hypotension) was performed to identify a bleeding complications. Ultrasound evaluation was performed for all patients after 24 hours from percutaneous renal biopsy to exclude a presence of complication, as hematoma and arteriovenous fistula Post biopsy bleeding complications were categorized as either minor or major. Minor bleeding complications included gross haematuria and/or subcapsular perinephric hematoma (<5cm diameter) that spontaneously resolved without need for further intervention. Major complications were defined as those that required an intervention for resolution, either the transfusion of blood products or an invasive procedure (angiography, surgery), and those that led to acute renal obstruction or failure, septicaemia, or death. The size of post biopsy hematoma (surface area) was defined as the product of the longest and the shortest diameters on the two-dimensional sonographic pictures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The present cohort includes 250 all adult patients who underwent percutaneous renal biopsy of native kidney in the Department of Emergency and Organ Transplantation, the University of Bari, Italy, from January 2017 to December 2018. Transplant kidney biopsies were excluded from this study.
Key inclusion criteria (1 listed)
- all patients undergoing standard percutaneous renal biopsy performed in our Unit
Key exclusion criteria (1 listed)
- contraindication to standard percutaneous renal biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bleeding After Kidney Biopsy
Time frame: 24 hours
Gross haematuria and/or subcapsular perinephric hematoma at ultrasound evaluation. Need for transfusion of blood products or an invasive procedure (angiography, surgery).
1 secondary outcome
Hemoglobin After Kidney Biopsy
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Platelet Disorder and Hemorrhage, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 18 Jun 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo Di Leo, Dr (+ 39 3332989599, vincenzodileo88@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding After Kidney Biopsy (time frame: 24 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 18 Jun 2019.