Hemostatic Powder Study in Cardiothoracic Surgery

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Questions and Answers

What was required to reduce bleeding and mortality during procedures?

Postoperative chest tube drainage

Dual agent antiplatelet therapy (correct)

Fresh frozen plasma administration

Single agent hemostatic therapy

Which hemostatic powder required 2 to 3 times more to be effective?

HEMOBLASTTM

AristaTM (correct)

Polysaccharide starch powder

Combination powder

What was not tracked in the study regarding the two hemostatic powders?

Intra-operative platelet counts

Safety of the powders

Detailed costs of usage (correct)

Postoperative cardiac surgical outcomes

What factor is directly linked to increased postoperative bleeding?

Antiplatelet therapy adherence Signup and view all the answers

In which plot type were the intra-operative platelets stratified?

By procedure type Signup and view all the answers

What is the primary objective of the clinical study?

To compare the efficacy of two hemostatic agents Signup and view all the answers

Which statistical method was used to analyze the data collected in the study?

Linear regression models Signup and view all the answers

How many patients were involved in the retrospective analysis of the combination powder?

68 patients Signup and view all the answers

What was one of the endpoints measured in this clinical study?

Length of hospital stay Signup and view all the answers

What types of cardiothoracic procedures were performed on the patients?

Transplantation and other procedures Signup and view all the answers

What were the genders of the patients involved in the study?

108 males and 54 females Signup and view all the answers

What is the name of the novel hemostatic agent being studied?

HEMOBLAST™ Bellows Signup and view all the answers

What type of study design is used in the assessment of the hemostatic agents?

Observational Signup and view all the answers

During which period was data for the polysaccharide starch powder collected?

January 2011 to January 2013 Signup and view all the answers

Which hemostatic agent is made from porcine collagen?

HEMOBLAST™ Signup and view all the answers

What is one of the enhancements provided by the CP hemostatic agent?

Activation of platelets by collagen Signup and view all the answers

What was the time frame for the CP group patients in this study?

July 2018 to July 2019 Signup and view all the answers

How many patients were included in the PP group for analysis?

94 patients Signup and view all the answers

Which group had surgeons in training involved in their procedures?

Neither group Signup and view all the answers

What surgical procedure type did both groups undergo?

Complex cardiothoracic procedures Signup and view all the answers

Who were the surgeons performing the surgeries in the CP group?

Senior members with more than 3 years in practice Signup and view all the answers

What was the primary aim of the study conducted by Bruckner et al.?

To analyze the outcomes of complex heart failure procedures Signup and view all the answers

What were the inclusion criteria mentioned for the study participants?

Patients with cessation of platelet inhibitors and correction of anemia Signup and view all the answers

Which surgical approach was primarily used for the procedures in this study?

Complete median sternotomy Signup and view all the answers

What percentage of patients required unplanned emergent re-exploration for bleeding?

Approximately 3 patients Signup and view all the answers

Which of the following was NOT listed as a morbidity in the study?

Pulmonary embolism Signup and view all the answers

What was the primary method for reversing heparinization after cardiopulmonary bypass?

Protamine sulfate administration Signup and view all the answers

What medical condition was associated with renal failure as mentioned in the study?

New onset requiring dialysis Signup and view all the answers

What type of medical records were reviewed for the study?

Inpatient and archived medical records Signup and view all the answers

What was the observed reduction in chest tube output after 48 hours in mL?

445.76 Signup and view all the answers

What was the P-value for the reduction in packed red blood cell transfusions?

0.001 Signup and view all the answers

Which postoperative measurement did not show a significant difference between the CP and PP groups?

Platelet transfusions Signup and view all the answers

What was the mean age of the CP group?

58.29 Signup and view all the answers

What was the estimated odds ratio for mortality within 30 days of surgery?

0.57 Signup and view all the answers

Which factor was considered in the secondary analysis regarding blood loss and mortality?

Age Signup and view all the answers

What statistical test was used to compare baseline demographics between the groups?

Two-sided t-test Signup and view all the answers

What influence was observed regarding ICU days?

Outliers had moderate influence on standard deviation Signup and view all the answers

Study Notes

Safety and Efficacy of a Novel Thrombin Containing Hemostatic Powder

A retrospective study compared a novel combination powder (CP) (HEMOBLAST™ Bellows) to an established polysaccharide starch powder (PP) (Arista™ AH) for hemostasis in cardiothoracic surgeries.
CP contained porcine collagen, bovine chondroitin sulfate, and human pooled plasma thrombin.
PP is a plant-derived, polysaccharide starch powder.
The study included 162 patients undergoing 162 complex cardiothoracic surgeries like heart transplants, lung transplants, and ventricular assist device placements.
The study compared blood loss, protamine to skin closure time, chest tube output, blood products, ICU stay, postoperative comorbidities, and 30-day mortality.
CP demonstrated a reduction in chest tube output, packed red blood cell transfusions, fresh frozen plasma transfusions, and postoperative comorbidities compared to PP.
However, there was no statistically significant difference in postoperative platelet transfusions, ICU stay, or 30-day mortality.
The study design was observational, with data collected from a single institution over two periods.
Study limitations include the observational nature of the study and the lack of detailed cost analysis for both modalities.

Procedure and Population

Subjects were identified from the institution's practice, inpatient data, medical records, and electronic medical records.
Inclusion criteria for patient recruitment were based on clinical practice for high-risk patients with high bleeding tendencies.
Patients had to cease platelet inhibitors for at least 5 days and have corrected hypothrombocytopenia, anemia, and coagulopathy.
Patients underwent cardiopulmonary bypass, except for 3 patients who required emergent re-exploration for bleeding within 24 hours.

Outcomes

After adjusting for age, sex, and procedure type, no significant differences were found between the CP and PP groups in terms of age, sex, procedure type, postoperative platelet transfusions, ICU stay, and 30-day mortality.
There was a statistically significant difference in chest tube output, packed red blood cell transfusions, fresh frozen plasma transfusions, and postoperative comorbidities.
Secondary analysis suggested an association between total blood loss and 30-day mortality.

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Description

This quiz explores a retrospective study comparing a novel hemostatic powder to an established polysaccharide starch powder used in cardiothoracic surgeries. It examines aspects like blood loss, transfusions, and postoperative outcomes based on data from 162 patients. Test your understanding of the efficacy and safety of these hemostatic agents.