Acute Upper Gastrointestinal HemorrhageNCT04174989
Clinical Investigation of Safety and Performance of a Medical Device (ClearPlasma) for the Treatment of Patients With Acute Upper Gastrointestinal Hemorrhage.
A study testing Plasma treated with ClearPlasma (Extra-corporeal plasma filtration device) and Regular fresh-frozen plasma (not treated) in people with Acute Upper Gastrointestinal Hemorrhage and Acute Upper Gastrointestinal Bleeding, run by PlasFree Ltd. at 8 sites in 3 countries.
Trial summary
Pre-market, multi-center, international, double-blind, randomized, controlled, prospective, first-in-human clinical investigation of a Class IIb Investigational Medical Device, in which Patients presenting with acute upper gastrointestinal hemorrhage (AUGIH) and due to undergo a plasma transfusion, will be randomized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Upper Gastrointestinal Hemorrhage, Acute Upper Gastrointestinal Bleeding
- What is being tested?
- Plasma treated with ClearPlasma (Extra-corporeal plasma filtration device) and Regular fresh-frozen plasma (not treated)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 24 Oct 2020to 13 Nov 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female Patients.
- Patients aged ≥ 18 and ≤ 80 years old.
- Patients presenting with acute upper gastrointestinal hemorrhage (> 0.5 L), diagnosed by presence of blood in gastric lavage, hematemesis or melena within no longer than 24 h before enrolment.
- Patients presenting with acute upper gastrointestinal hemorrhage (< 24 h) for which fresh frozen plasma (FFP) has been ordered.
- Patients understanding the nature of the study and providing their informed consent to participation.
- Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol.
Who cannot join
- Patients who underwent a plasma infusion in the 30 days before enrolment.
- Patients in a life-threatening condition at the time of enrolment.
- Patient on anticoagulant therapy at the time of enrolment.
- Patients with known renal failure (creatinine clearance < 30 mL/min) at the time of enrolment.
- Patients suffering of Hemophilia A or B.
- Patients suffering of venous and arterial thromboembolic events within 3 months before the enrolment.
Show all 14Show fewer
- Patients with history of allergic reaction to plasma, polyethersyplone or polycarbonate.
- Patients suffering of IgA deficiency at the time of enrolment.
- Patients with history of hemorrhage while on anticoagulant treatment (warfarin, apixaban, rivaroxaban, dabigatran, low molecular weight heparin).
- Patients identified by the Investigator to have any underlying medical conditions that may preclude conduct of study procedure (i.e. making the administration of study treatment hazardous) or obscure the interpretation of safety objectives.
- Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment.
- Women who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical investigation and for 3 months later.
- Female Patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception *.
- Methods at low risk of contraceptive failure (less than 1% per year) when used consistently, including: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), some intra-uterine devices.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Czechia3 sites
Charles University Teaching Hospital
Hradec Králové, 50005
University Hospital in Olomouc
Olomouc, 77900
University Hospital Ostrava
Ostrava, 70852
Israel3 sites
Wolfson Medical center
Holon, 5822012
Department of Surgery B, Meir Medical Center Kfar Saba
Kfar Saba, 4428164
Department of Surgery, Rabin Medical Center
Petah Tikva, 49100
Italy2 sites
S.C. di Anestesia e Rianimazione 1, Azienda Ospedaliera Universitaria Policlinico di Modena
Modena, 41124
Area Medicina D'Urgenza e Pronto Soccorso, Fondazione Policlinico Universitario A. Gemelli
Roma, 00168
About this study
Official title: MULTI-CENTER,DOUBLE-BLIND, RANDOMIZED, TWO-ARMS, CONTROLLED, PROSPECTIVE CLINICAL INVESTIGATION ASSESSING THE SAFETY AND PERFORMANCE OF A CLASS IIb MEDICAL DEVICE (CLEARPLASMATM) FOR THE TREATMENT OF PATIENTS WITH ACUTE UPPER GASTROINTESTINAL HEMORRHAGE.
Pre-market, multi-center, international, double-blind, randomized, controlled, prospective, first-in-human clinical investigation of a Class IIb Investigational Medical Device, in which Patients presenting with acute upper gastrointestinal hemorrhage (AUGIH) and due to undergo a plasma transfusion, will be randomized to receive a one-time infusion (up to 8 hours) of up to two 250 mL units of plasminogen-depleted plasma (PDP) or fresh-frozen plasma (FFP).
In case of transfusions needing more than two units, the third unit and above will consist in regular plasma for both treatment groups. Patients will be continuously monitored for 8 hours following the transfusion, and will be assessed between 8-12 hours after plasma transfusion or the following morning (the earlier of the two options), between 24-48 hours after plasma transfusion or at discharge (the earlier of the two options) and after 30+/-3 days after transfusion.
Read the detailed description
Upper gastrointestinal hemorrhage (UGIH) is one of the most common gastrointestinal emergencies, and is associated with significant morbidity and mortality. Acute upper gastrointestinal hemorrhage (AUGIH) management guidelines call for aggressive hemodynamic resuscitation, prevention and treatment of complications and treatment of bleeding, which generally includes endoscopic intervention and transfusion of appropriate blood components. However, in many cases, spontaneous hyperfibrinolysis occurs, jeopardizing pharmacological control of AUGIH. Antifibrinolytic drugs are considered effective in counteracting hyperfibrinolysis, but are associated with various side effects, such as neurotoxicity and accelerated fibrinolysis upon prolonged use.
Fibrin clot breakdown is actively mediated by plasmin, a serine protease which cleaves fibrin. Administration of plasma depleted of plasminogen, the precursor of plasmin, may shift the balance towards coagulation.
PlasFree Ltd. has developed ClearPlasma, a single-use, extracorporeal plasma filtration device which extracts plasminogen from plasma to reduce fibrinolysis. The resulting plasminogen-depleted plasma (PDP) is expected to reduce risk of fibrinolysis and re-bleeding in Patients undergoing plasma transfusions.
The Primary Objective of this trial is to assess the safety profile of a one-time infusion of up to two units of PDP obtained through filtration with ClearPlasma in Patients presenting with acute upper gastrointestinal hemorrhage and to compare it to the same procedure carried out using FFP units.
The Secondary Objective of this trial is to assess the efficacy of a one-time infusion of up to two units of PDP obtained through filtration with ClearPlasma in the reduction of re-bleeding in Patients presenting with acute upper gastrointestinal hemorrhage (as a measure of the performance of ClearPlasma) and to compare it to the same procedure carried out using FFP units.
- Being tested
- Plasma treated with ClearPlasma (Extra-corporeal plasma filtration device), Regular fresh-frozen plasma (not treated)
- Keywords
- Acute Upper Gastrointestinal Hemorrhage, Gastrointestinal Hemorrhage, Gastrointestinal Bleeding, Acute Upper Gastrointestinal Bleeding, Plasminogen-Depleted Plasma, Plasma Transfusion
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma treated with ClearPlasma (Extra-corporeal plasma filtration device)Other
ClearPlasma is designed to specifically extract plasminogen, a protein that drives fibrinolysis, from up to 250 mL of plasma. ClearPlasma is a non-pyrogenic, sterile, single-use medical device that is indicated for use in conditions where massive bleeding situations exist.
Regular fresh-frozen plasma (not treated)Other
Regular fresh-frozen plasma (not treated)
| Study group | Role | What they receive |
|---|---|---|
| Plasminogen-Depleted Plasma Infusion | Experimental | Patients presenting with acute upper gastrointestinal hemorrhage (AUGIH) and due to undergo a plasma transfusion, will be randomized to receive a one-time infusion (up to 8 hours) of up to two 250 mL units of PDP. In case of transfusions needing more than two units, the third unit and above will consist in regular plasma regardless of treatment group. Patients will be continuously monitored for 8 hours following the transfusion, and will be assessed between 8-12 hours after plasma transfusion or the following morning (the earlier of the two options), between 24-48 hours after plasma transfusion or at discharge (the earlier of the two options) and after 30±3 days after transfusion. Receives: Other: Plasma treated with ClearPlasma (Extra-corporeal plasma filtration device) |
| Fresh-Frozen Plasma Infusion | Other | Patients presenting with acute upper gastrointestinal hemorrhage (AUGIH) and due to undergo a plasma transfusion, will be randomized to receive a one-time infusion (up to 8 hours) of up to two 250 mL units of FFP. In case of transfusions needing more than two units, the third unit and above will consist in regular plasma regardless of treatment group. Patients will be continuously monitored for 8 hours following the transfusion, and will be assessed between 8-12 hours after plasma transfusion or the following morning (the earlier of the two options), between 24-48 hours after plasma transfusion or at discharge (the earlier of the two options) and after 30±3 days after transfusion. Receives: Other: Regular fresh-frozen plasma (not treated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Profile in Patients treated with PDP versus FFP.
Comparison of adverse events rate during the study period and within 30±3 days after transfusion with PDP (group A) or FFP (group B). All adverse occurrences (serious/non-serious or device-related/non-device related) will be recorded prospectively, categorized and evaluated for causality using defined criteria.
Measured: Entire Study Period (up to 1 month per patient).
Secondary outcomes (9)
Incidence of re-bleeding episodes in Patients treated with PDP versus FFP.
Comparison of the number of re-bleeding episodes occurring for the Patient throughout the study period and within 30±3 days after transfusion with PDP (group A) or FFP (group B).
Measured: Entire Study Period (up to 1 month per patient).
Duration of hospital stay in Patients treated with PDP versus FFP.
Comparison of the duration of the hospital stay for the Patient up to 30±3 days after transfusion with PDP (group A) or FFP (group B).
Measured: Entire Study Period (up to 1 month per patient) or until patient discharge.
CBC profile in Patients treated with PDP versus FFP.
Comparison of complete blood count (CBC) profiles between Patients who received transfusion with PDP (group A) or FFP (group B) at baseline (Screening Visit) versus T=8-12h, T=24-48h and End of Study Visit.
Measured: Entire Study Period (up to 1 month per patient).
D-dimer profile in Patients treated with PDP versus FFP.
Comparison of D-dimer profiles between Patients who received transfusion with PDP (group A) or FFP (group B) at baseline (Screening Visit) versus T=8-12h, T=24-48h and End of Study Visit.
Measured: Entire Study Period (up to 1 month per patient).
PT/INR (blood coagulation parameter) measurement in Patients treated with PDP versus FFP.
Comparison of Prothrombin Time and International Normalized Ratio (PT/INR) between Patients who received transfusion with PDP (group A) or FFP (group B) until Patient discharge from hospital.
Measured: Entire Study Period (up to 1 month per patient) or until patient discharge.
aPTT (blood coagulation parameter) measurement in Patients treated with PDP versus FFP.
Comparison of Activated Partial Thromboplastin Time (aPTT) between Patients who received transfusion with PDP (group A) or FFP (group B) until Patient discharge from hospital.
Measured: Entire Study Period (up to 1 month per patient) or until patient discharge.
Incidence of venous and arterial thromboembolic events in Patients treated with PDP versus FFP.
Comparison of the incidence of venous and arterial thromboembolic events during the study period and within 30±3 days after transfusion with PDP (group A) or FFP (group B).
Measured: Entire Study Period (up to 1 month per patient).
Plasma transfusion-related mortality in Patients treated with PDP versus FFP.
Comparison of the plasma transfusion-related mortality during the study period and within 30±3 days after transfusion with PDP (group A) or FFP (group B).
Measured: Entire Study Period (up to 1 month per patient).
Total blood loss from transfusion in Patients treated with PDP versus FFP.
Comparison of total blood loss from transfusion with PDP (group A) or FFP (group B) until Patient discharge from hospital, as measured by:
- Red blood cells (RBC) units transfused;
- Plasma units transfused;
- Platelet units transfused;
- Hemoglobin levels.
Measured: Entire Study Period (up to 1 month per patient) or until patient discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start24 Oct 2020
- Primary completion30 Jun 2022
- Study completion13 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Upper Gastrointestinal HemorrhageStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, international, double-blind, randomized, controlled, prospective, first-in-human clinical investigation, in which Patients presenting with acute upper gastrointestinal hemorrhage (AUGIH) and required plasma transfusion, will be randomized to receive a one-time infusion (up to 8 hours) of up to two 250 mL units of PDP (group A) or FFP (group B). The administration of Plasma needs to be in line with the clinical practice and doctor decision.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- PlasFree Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KCRI
- Responsible party
- Sponsor
- Investigators
- Francesco Franceschi, MD, Principal investigator, Chief of Emergency Medicine Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del Sacro Cuore Largo A. Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174989
- Sponsor's protocol ID
- PLAS-01-2019
- Status last verified
- Nov 2022
- First submitted
- 18 Nov 2019
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arya RC, Wander G, Gupta P. Blood component therapy: Which, when and how much. J Anaesthesiol Clin Pharmacol. 2011 Apr;27(2):278-84. doi: 10.4103/0970-9185.81849.
PubMed 21772701Demarmels Biasiutti F, Sulzer I, Stucki B, Wuillemin WA, Furlan M, Lammle B. Is plasminogen deficiency a thrombotic risk factor? A study on 23 thrombophilic patients and their family members. Thromb Haemost. 1998 Jul;80(1):167-70.
PubMed 9684804Hirayama F. Current understanding of allergic transfusion reactions: incidence, pathogenesis, laboratory tests, prevention and treatment. Br J Haematol. 2013 Feb;160(4):434-44. doi: 10.1111/bjh.12150. Epub 2012 Dec 6.
PubMed 23215650Matei D, Groza I, Furnea B, Puie L, Levi C, Chiru A, Cruciat C, Mester G, Vesa SC, Tantau M. Predictors of variceal or nonvariceal source of upper gastrointestinal bleeding. An etiology predictive score established and validated in a tertiary referral center. J Gastrointestin Liver Dis. 2013 Dec;22(4):379-84.
PubMed 24369318Pandey S, Vyas GN. Adverse effects of plasma transfusion. Transfusion. 2012 May;52 Suppl 1(Suppl 1):65S-79S. doi: 10.1111/j.1537-2995.2012.03663.x.
PubMed 22578374Rockall TA, Logan RF, Devlin HB, Northfield TC. Incidence of and mortality from acute upper gastrointestinal haemorrhage in the United Kingdom. Steering Committee and members of the National Audit of Acute Upper Gastrointestinal Haemorrhage. BMJ. 1995 Jul 22;311(6999):222-6. doi: 10.1136/bmj.311.6999.222.
PubMed 7627034Rubinstein LV, Steinberg SM, Kummar S, Kinders R, Parchment RE, Murgo AJ, Tomaszewski JE, Doroshow JH. The statistics of phase 0 trials. Stat Med. 2010 May 10;29(10):1072-6. doi: 10.1002/sim.3840.
PubMed 20419759Schuster V, Hugle B, Tefs K. Plasminogen deficiency. J Thromb Haemost. 2007 Dec;5(12):2315-22. doi: 10.1111/j.1538-7836.2007.02776.x. Epub 2007 Sep 26.
PubMed 17900274Association of Anaesthetists of Great Britain and Ireland; Thomas D, Wee M, Clyburn P, Walker I, Brohi K, Collins P, Doughty H, Isaac J, Mahoney PM, Shewry L. Blood transfusion and the anaesthetist: management of massive haemorrhage. Anaesthesia. 2010 Nov;65(11):1153-61. doi: 10.1111/j.1365-2044.2010.06538.x.
PubMed 20963925Wilkins T, Khan N, Nabh A, Schade RR. Diagnosis and management of upper gastrointestinal bleeding. Am Fam Physician. 2012 Mar 1;85(5):469-76.
PubMed 22534226
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MULTI-CENTER,DOUBLE-BLIND, RANDOMIZED, TWO-ARMS, CONTROLLED, PROSPECTIVE CLINICAL INVESTIGATION ASSESSING THE SAFETY AND PERFORMANCE OF A CLASS IIb MEDICAL DEVICE (CLEARPLASMATM) FOR THE TREATMENT OF PATIENTS WITH ACUTE UPPER GASTROINTESTINAL HEMORRHAGE.
- ClinicalTrials.gov ID
- NCT04174989
- Acronym / sponsor ID
- PLAS-01-2019
- Keywords
- Acute Upper Gastrointestinal Hemorrhage, Gastrointestinal Hemorrhage, Gastrointestinal Bleeding, Acute Upper Gastrointestinal Bleeding, Plasminogen-Depleted Plasma, Plasma Transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- PlasFree Ltd.Industry (pharma, biotech, devices)
- Collaborators
- KCRI
- Study start
- 24 Oct 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 13 Nov 2022 (actual)
- First posted
- 22 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.
Pre-market, multi-center, international, double-blind, randomized, controlled, prospective, first-in-human clinical investigation of a Class IIb Investigational Medical Device, in which Patients presenting with acute upper gastrointestinal hemorrhage (AUGIH) and due to undergo a plasma transfusion, will be randomized to receive a one-time infusion (up to 8 hours) of up to two 250 mL units of plasminogen-depleted plasma (PDP) or fresh-frozen plasma (FFP).
In case of transfusions needing more than two units, the third unit and above will consist in regular plasma for both treatment groups. Patients will be continuously monitored for 8 hours following the transfusion, and will be assessed between 8-12 hours after plasma transfusion or the following morning (the earlier of the two options), between 24-48 hours after plasma transfusion or at discharge (the earlier of the two options) and after 30+/-3 days after transfusion.
Detailed description
Upper gastrointestinal hemorrhage (UGIH) is one of the most common gastrointestinal emergencies, and is associated with significant morbidity and mortality. Acute upper gastrointestinal hemorrhage (AUGIH) management guidelines call for aggressive hemodynamic resuscitation, prevention and treatment of complications and treatment of bleeding, which generally includes endoscopic intervention and transfusion of appropriate blood components. However, in many cases, spontaneous hyperfibrinolysis occurs, jeopardizing pharmacological control of AUGIH. Antifibrinolytic drugs are considered effective in counteracting hyperfibrinolysis, but are associated with various side effects, such as neurotoxicity and accelerated fibrinolysis upon prolonged use.
Fibrin clot breakdown is actively mediated by plasmin, a serine protease which cleaves fibrin. Administration of plasma depleted of plasminogen, the precursor of plasmin, may shift the balance towards coagulation.
PlasFree Ltd. has developed ClearPlasma, a single-use, extracorporeal plasma filtration device which extracts plasminogen from plasma to reduce fibrinolysis. The resulting plasminogen-depleted plasma (PDP) is expected to reduce risk of fibrinolysis and re-bleeding in Patients undergoing plasma transfusions.
The Primary Objective of this trial is to assess the safety profile of a one-time infusion of up to two units of PDP obtained through filtration with ClearPlasma in Patients presenting with acute upper gastrointestinal hemorrhage and to compare it to the same procedure carried out using FFP units.
The Secondary Objective of this trial is to assess the efficacy of a one-time infusion of up to two units of PDP obtained through filtration with ClearPlasma in the reduction of re-bleeding in Patients presenting with acute upper gastrointestinal hemorrhage (as a measure of the performance of ClearPlasma) and to compare it to the same procedure carried out using FFP units.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Multi-center, international, double-blind, randomized, controlled, prospective, first-in-human clinical investigation, in which Patients presenting with acute upper gastrointestinal hemorrhage (AUGIH) and required plasma transfusion, will be randomized to receive a one-time infusion (up to 8 hours) of up to two 250 mL units of PDP (group A) or FFP (group B). The administration of Plasma needs to be in line with the clinical practice and doctor decision.
| Arm | Type | Receives |
|---|---|---|
| Plasminogen-Depleted Plasma Infusion | Experimental | Other: Plasma treated with ClearPlasma (Extra-corporeal plasma filtration device)Patients presenting with acute upper gastrointestinal hemorrhage (AUGIH) and due to undergo a plasma transfusion, will be randomized to receive a one-time infusion (up to 8 hours) of up to two 250 mL units of PDP. In case of transfusions needing more than two units, the third unit and above will consist in regular plasma regardless of treatment group. Patients will be continuously monitored for 8 hours following the transfusion, and will be assessed between 8-12 hours after plasma transfusion or the following morning (the earlier of the two options), between 24-48 hours after plasma transfusion or at discharge (the earlier of the two options) and after 30±3 days after transfusion. |
| Fresh-Frozen Plasma Infusion | Other | Other: Regular fresh-frozen plasma (not treated)Patients presenting with acute upper gastrointestinal hemorrhage (AUGIH) and due to undergo a plasma transfusion, will be randomized to receive a one-time infusion (up to 8 hours) of up to two 250 mL units of FFP. In case of transfusions needing more than two units, the third unit and above will consist in regular plasma regardless of treatment group. Patients will be continuously monitored for 8 hours following the transfusion, and will be assessed between 8-12 hours after plasma transfusion or the following morning (the earlier of the two options), between 24-48 hours after plasma transfusion or at discharge (the earlier of the two options) and after 30±3 days after transfusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female Patients.
- Patients aged ≥ 18 and ≤ 80 years old.
- Patients presenting with acute upper gastrointestinal hemorrhage (> 0.5 L), diagnosed by presence of blood in gastric lavage, hematemesis or melena within no longer than 24 h before enrolment.
- Patients presenting with acute upper gastrointestinal hemorrhage (< 24 h) for which fresh frozen plasma (FFP) has been ordered.
- Patients understanding the nature of the study and providing their informed consent to participation.
Key exclusion criteria (14 listed)
- Patients who underwent a plasma infusion in the 30 days before enrolment.
- Patients in a life-threatening condition at the time of enrolment.
- Patient on anticoagulant therapy at the time of enrolment.
- Patients with known renal failure (creatinine clearance < 30 mL/min) at the time of enrolment.
- Patients suffering of Hemophilia A or B.
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 |
|---|---|---|
| Plasma treated with ClearPlasma (Extra-corporeal plasma filtration device)ClearPlasma is designed to specifically extract plasminogen, a protein that drives fibrinolysis, from up to 250 mL of plasma. ClearPlasma is a non-pyrogenic, sterile, single-use medical device that is indicated for use in conditions where massive bleeding situations exist. | Other | Plasminogen-Depleted Plasma Infusion |
| Regular fresh-frozen plasma (not treated)Regular fresh-frozen plasma (not treated) | Other | Fresh-Frozen Plasma Infusion |
Primary outcome
Safety Profile in Patients treated with PDP versus FFP.
Time frame: Entire Study Period (up to 1 month per patient).
Comparison of adverse events rate during the study period and within 30±3 days after transfusion with PDP (group A) or FFP (group B). All adverse occurrences (serious/non-serious or device-related/non-device related) will be recorded prospectively, categorized and evaluated for causality using defined criteria.
9 secondary outcomes
Incidence of re-bleeding episodes in Patients treated with PDP versus FFP.
Time frame: Entire Study Period (up to 1 month per patient).
Duration of hospital stay in Patients treated with PDP versus FFP.
Time frame: Entire Study Period (up to 1 month per patient) or until patient discharge.
CBC profile in Patients treated with PDP versus FFP.
Time frame: Entire Study Period (up to 1 month per patient).
D-dimer profile in Patients treated with PDP versus FFP.
Time frame: Entire Study Period (up to 1 month per patient).
PT/INR (blood coagulation parameter) measurement in Patients treated with PDP versus FFP.
Time frame: Entire Study Period (up to 1 month per patient) or until patient discharge.
aPTT (blood coagulation parameter) measurement in Patients treated with PDP versus FFP.
Time frame: Entire Study Period (up to 1 month per patient) or until patient discharge.
Incidence of venous and arterial thromboembolic events in Patients treated with PDP versus FFP.
Time frame: Entire Study Period (up to 1 month per patient).
Plasma transfusion-related mortality in Patients treated with PDP versus FFP.
Time frame: Entire Study Period (up to 1 month per patient).
Total blood loss from transfusion in Patients treated with PDP versus FFP.
Time frame: Entire Study Period (up to 1 month per patient) or until patient discharge.
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 15 Nov 2022.
- Background: PubMed 21772701Arya RC, Wander G, Gupta P. Blood component therapy: Which, when and how much. J Anaesthesiol Clin Pharmacol. 2011 Apr;27(2):278-84. doi: 10.4103/0970-9185.81849.
- Background: PubMed 9684804Demarmels Biasiutti F, Sulzer I, Stucki B, Wuillemin WA, Furlan M, Lammle B. Is plasminogen deficiency a thrombotic risk factor? A study on 23 thrombophilic patients and their family members. Thromb Haemost. 1998 Jul;80(1):167-70.
- Background: PubMed 23215650Hirayama F. Current understanding of allergic transfusion reactions: incidence, pathogenesis, laboratory tests, prevention and treatment. Br J Haematol. 2013 Feb;160(4):434-44. doi: 10.1111/bjh.12150. Epub 2012 Dec 6.
- Background: PubMed 24369318Matei D, Groza I, Furnea B, Puie L, Levi C, Chiru A, Cruciat C, Mester G, Vesa SC, Tantau M. Predictors of variceal or nonvariceal source of upper gastrointestinal bleeding. An etiology predictive score established and validated in a tertiary referral center. J Gastrointestin Liver Dis. 2013 Dec;22(4):379-84.
- Background: PubMed 22578374Pandey S, Vyas GN. Adverse effects of plasma transfusion. Transfusion. 2012 May;52 Suppl 1(Suppl 1):65S-79S. doi: 10.1111/j.1537-2995.2012.03663.x.
- Background: PubMed 7627034Rockall TA, Logan RF, Devlin HB, Northfield TC. Incidence of and mortality from acute upper gastrointestinal haemorrhage in the United Kingdom. Steering Committee and members of the National Audit of Acute Upper Gastrointestinal Haemorrhage. BMJ. 1995 Jul 22;311(6999):222-6. doi: 10.1136/bmj.311.6999.222.
- Background: PubMed 20419759Rubinstein LV, Steinberg SM, Kummar S, Kinders R, Parchment RE, Murgo AJ, Tomaszewski JE, Doroshow JH. The statistics of phase 0 trials. Stat Med. 2010 May 10;29(10):1072-6. doi: 10.1002/sim.3840.
- Background: PubMed 17900274Schuster V, Hugle B, Tefs K. Plasminogen deficiency. J Thromb Haemost. 2007 Dec;5(12):2315-22. doi: 10.1111/j.1538-7836.2007.02776.x. Epub 2007 Sep 26.
- Background: PubMed 20963925Association of Anaesthetists of Great Britain and Ireland; Thomas D, Wee M, Clyburn P, Walker I, Brohi K, Collins P, Doughty H, Isaac J, Mahoney PM, Shewry L. Blood transfusion and the anaesthetist: management of massive haemorrhage. Anaesthesia. 2010 Nov;65(11):1153-61. doi: 10.1111/j.1365-2044.2010.06538.x.
- Background: PubMed 22534226Wilkins T, Khan N, Nabh A, Schade RR. Diagnosis and management of upper gastrointestinal bleeding. Am Fam Physician. 2012 Mar 1;85(5):469-76.
- PlasFree Ltd. official websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Active, not recruiting
Timing of Endoscopy in Cirrhotic Patients With Acute Variceal Bleeding
Acute Upper Gastrointestinal Bleeding, Acute Variceal Bleeding
RecruitingPhase 4
Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy
Coronary Artery Disease, Percutaneous Coronary Intervention
Not yet recruiting
Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Variceal Bleeding and Renal Dysfunction
Liver Cirrhosis
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.
Francesco Franceschi, MD principal investigator
Chief of Emergency Medicine Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del Sacro Cuore Largo A. Gemelli
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma treated with ClearPlasma (Extra-corporeal plasma filtration device) and Regular fresh-frozen plasma (not treated) in people with Acute Upper Gastrointestinal Hemorrhage and Acute Upper Gastrointestinal Bleeding, run by PlasFree Ltd. at 8 sites in 3 countries.
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 6 inclusion and 14 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 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Czechia, Israel, 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?
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?
Safety Profile in Patients treated with PDP versus FFP. (time frame: Entire Study Period (up to 1 month per patient).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04174989, which also lists 10 linked publications.
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 15 Nov 2022.