CLINICAL TRIAL

Bentracimab (PB2452) Infusion for Hemorrhage

High Risk
Recruiting · 18+ · All Sexes · Upland, PA

Bentracimab (PB2452) in Ticagrelor-treated Patients With Uncontrolled Major or Life-Threatening Bleeding or Requiring Urgent Surgery or Invasive Procedure

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About the trial for Hemorrhage

Eligible Conditions
Invasive Procedure · Hemorrhage · Urgent Surgery

Treatment Groups

This trial involves 2 different treatments. Bentracimab (PB2452) Infusion is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Bentracimab (PB2452) Infusion
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
If you are at risk of experiencing life-threatening events, such as shock, a heart attack, or a stroke, then it is important to be aware that significant intraoperative or postoperative bleeding can occur show original
in a 24-hour period The patient has a corrected hemoglobin level below 8.0 g/dL, a fall in hemoglobin level of at least 2.0 g/dL from a known baseline, or a requirement for transfusion of 2 or more units of packed red blood cells in a 24-hour period. show original
Needs surgery that is urgent and risky for bleeding. show original
This text is about a potentially life-threatening condition that can cause severe bleeding and a decrease in blood pressure show original
+ A hemorrhage in a vital organ or enclosed space, such as an intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular bleed that causes compartment syndrome. show original
Anyone aged 18 or over who agrees to take part in the study can do so, either in writing or verbally. show original
If you took ticagrelor in the past three days, you must wait seven days before taking cyclosporine. show original
Requires surgery that may have an adverse outcome if hemostasis is impaired. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Any time point between infusion initiation and Day 3 (Pre-dose, 5-10 minutes, 30+5 minutes, 1+0.25 hours, 4+0.25 hours, 12+0.5 hours, 24+1 hours, and Day 3)
Screening: ~3 weeks
Treatment: Varies
Reporting: Any time point between infusion initiation and Day 3 (Pre-dose, 5-10 minutes, 30+5 minutes, 1+0.25 hours, 4+0.25 hours, 12+0.5 hours, 24+1 hours, and Day 3)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Any time point between infusion initiation and Day 3 (Pre-dose, 5-10 minutes, 30+5 minutes, 1+0.25 hours, 4+0.25 hours, 12+0.5 hours, 24+1 hours, and Day 3).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Bentracimab (PB2452) Infusion will improve 3 primary outcomes and 9 secondary outcomes in patients with Hemorrhage. Measurement will happen over the course of 4 hours post-initiation of infusion.

Maximum reversal of PRI assessed by VASP
4 HOURS POST-INITIATION OF INFUSION
Maximum reversal of PRI assessed by VASP within 4 hours after the initiation of study drug.
4 HOURS POST-INITIATION OF INFUSION
Hemostasis - Uncontrolled major of life-threatening bleeding - Achievement
4 HOURS POST-INITIATION OF INFUSION
Achievement of effective (graded as good or excellent) hemostasis following initiation of infusion will be centrally adjudicated using prespecified criteria for effective hemostasis for visible and non-visible major bleeding [Scale (from best to worst) measured as: Excellent, Good, Poor/None]
4 HOURS POST-INITIATION OF INFUSION
Minimum % inhibition of Platelet Reactivity Index (PRI) (VASP)
4 HOURS POST-INITIATION OF INFUSION
Minimum % inhibition of PRI assessed by VASP within 4 hours after the initiation of study drug
4 HOURS POST-INITIATION OF INFUSION
Reversal - Platelet Reactivity Units (PRU)
4 HOURS POST-INITIATION OF INFUSION
Minimum % inhibition of PRU within 4 hours of the initiation of study drug as assessed by VerifyNow™ PRUTest™ platelet function assay
4 HOURS POST-INITIATION OF INFUSION
Hemostasis - Urgent surgery or invasive procedure - Achievement
4 HOURS POST-INITIATION OF INFUSION
Achievement of effective hemostasis following initiation of infusion will be centrally adjudicated using prespecified criteria for effective hemostasis derived from the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) clinical bleeding scale [GUSTO scale (from best to worst): Effective (no bleeding, mild bleeding or moderate bleeding) or Not effective (severe bleeding)]
4 HOURS POST-INITIATION OF INFUSION
Maximum reversal of PRU assessed by VerifyNow™ PRUTest™
4 HOURS POST-INITIATION OF INFUSION
Maximum reversal of PRU assessed by VerifyNow™ PRUTest™ within 4 hours after the initiation of study drug.
4 HOURS POST-INITIATION OF INFUSION
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of hemorrhage?

Signs that may precede a hemorrhage include headache, loss of appetite, and changes in behavior. Decrease in alertness, inability to respond adequately to stimuli, lack of motivation, confusion, irritability, sleep deprivation, or headaches of a new type should all be considered as evidence of a possible hemorrhage or bleed. If any of these symptoms occur together or persist for two days, then a hemorrhage may be present. The most common sites of hemorrhage are due to trauma such as a fall, or medical procedures. However, the diagnosis may also come from blood tests or imaging. If a suspicion of traumatic hemorrhage with multiple indications is present, then further investigations are necessary to establish the diagnosis.

Anonymous Patient Answer

Can hemorrhage be cured?

[Caudate nucleus decompression is a viable treatment for severe acute hemorrhage when applied before cerebral tissue death occurs and is the only effective therapy available which can be applied with a low risk of dying on the operating table.

Anonymous Patient Answer

What is hemorrhage?

The word 'hemorrhage' originally meant 'blood loss' and was used for that sense from its usage in the 15th century until the 1870s. The word 'hem' came from "hemos", which came from the Latin word "hēmos", which is Latin for 'blood'.\n

Anonymous Patient Answer

What causes hemorrhage?

Most cases of traumatic hemorrhage are caused by accidents, usually accidents at work, but also by traffic or falls. Some causes are not clear, but a few factors can lead to a high risk of traumatic hemorrhage. These factors include heart attack, high blood pressure, liver and stomach tumors, and medications.

Anonymous Patient Answer

How many people get hemorrhage a year in the United States?

It is estimated that 6 to 8 million people suffer from hemorrhage each year in the US. Half of the deaths associated with hemorrhage occur in patients with comorbid disease and chronic conditions.

Anonymous Patient Answer

What are common treatments for hemorrhage?

Hematopoietic progenitor cells are mobilized to a state of high activity, and cytokine therapy may increase this activity, which may, in turn, enhance their engraftment into the bloodstream. Other approaches, such as antifibrinolytic agents and immunosuppressants, may be useful in other ways.

Anonymous Patient Answer

Have there been any new discoveries for treating hemorrhage?

Treatments for bleeding disorders have become increasingly complex and more effective in treating bleeding disorders. At the beginning of 2020, there are many novel treatments being developed for bleeding disorders. However, the most effective of these treatments remains the RBC transfusion, which is only effective for a short period of time. Novel therapies for treating bleeding disorders and controlling bleeding disorders are needed. [Power(https://www.withpower.com/clinical-trials/hemorrhage) provides a quick way to find bleeding disorders clinical trials tailored to your exact condition.

Anonymous Patient Answer

What is the latest research for hemorrhage?

There are very few studies with randomized clinical trials that examine the use of recombinant HSPGs in the hemostatic management of patients with traumatic or chronic wound bleeding. The use of HSPG-C has not been studied in comparison with other HSPG's, such as HSPG-A and HSPG-B, which have more data available. Current research seems to indicate an advantage in using HSPG-C in chronic wound bleeding management.

Anonymous Patient Answer

What is the primary cause of hemorrhage?

Of the hemorrhage patients admitted to the hospital, more than half presented with multiple causes. Primary causes were [blood vessel rupture/tamponade (37%); perforation/tamponade, ulcer lesion or fistulas, and malignancy, (31%); gastrointestinal rupture, arterial bleed or rupture, (31%). The most common causes are [blood vessel rupture/tamponade and perforation (20%); trauma (19%); and malignancy (tamponade or fistula/arterty rupture/tamponade (3%)].

Anonymous Patient Answer

Does hemorrhage run in families?

Hemorrhagic diseases are common in Hirschsprung's disease and other intestinal diseases with autosomal recessive mode of inheritance. The prevalence in general population is estimated between 3% and 9% in Germany and Denmark, respectively, i.e. comparable with other hereditary chronic illnesses, such as Huntington's disease, in which hemorrhagic diseases are not rare. There are very few genes responsible for hemorrhagic diseases in the general population at present. Thus, Hirschsprung's disease and other intestinal diseases with autosomal recessive mode of inheritance are not linked with hereditary hemorrhagic diseases.

Anonymous Patient Answer

Is bentracimab (pb2452) infusion typically used in combination with any other treatments?

The pb2 antibody infusion is likely to be the most frequently used combination treatment regimen with any other treatment, particularly whenever immunosuppression is also involved, for the treatment of refractory patients with IBD.

Anonymous Patient Answer

Is bentracimab (pb2452) infusion safe for people?

Bentracimboin injection in the absence of dialysis is an effective treatment of acute antibody-associated hemolytic anemia caused by pb2472 antibodies. It appears to produce a safe and effective remission and recovery of the patient.

Anonymous Patient Answer
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