Collagen-thrombin Matrix Efficacy During Cardiac Surgery: a Prospective Randomized Controlled Trial

NCT04310150 | Completed Phase 4 DMC FDA Device

• 1 other identifier: 1-2017-0094
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective open-label randomized trial, 160 patients with elective off-pump coronary artery bypass (OPCAB) surgery were enrolled. After primary suture of aortocoronary anastomosis, if an area of hemorrhage was identified, patients were randomized to receive Floseal® or Collastat® (n=80), respectively. The selected agent was applied with compression of the target area for 1 min. If hemostasis was not achieved, the agent was re-applied for a further 1 min, and was repeated up to 5 min, after which rescue treatment was applied, including any conventional surgical methods.

Conditions

Coronary Artery Disease

Keywords

Bleeding; Blood transfusion; Coronary artery bypass surgery; Hemostasis; Topical therapy

Outcome Measures

Primary Outcomes (1)

• the proportion of patients with complete hemostasis

  The primary end points were the proportion of patients with complete hemostasis within or up to 5 min for the aortocoronary anastomosis site treated by hemostatic agents Floseal® or Collastat®

  Participants will be followed for the time required for hemostasis, an expected average of 3 minutes.

Secondary Outcomes (5)

• blood loss in the operative day

  24 hours later after surgery

• amount of blood products transfused both intraoperatively and postoperatively

  24 hours later after surgery

• rate of surgical revision for bleeding

  5 minutes later after anastomosis

• total length of intensive care unit (ICU) stay

  mean 3-4 days after surgery

• rate of postoperative morbidity/mortality

  Participants will be followed during 1 years from operation

Study Arms (2)

Treatment arm label- Collastat®

EXPERIMENTAL

Drug: Collastat

Control arm label- Floseal®

ACTIVE COMPARATOR

an marketed product is Floseal

Device: Floseal

Interventions

Collastat DRUG

hemostatic agent that combine porcine-derived collagen thrombin

Also known as: absorbable collagen hemostasis

Treatment arm label- Collastat®

Floseal DEVICE

hemostatic agent that combine bovine-derived gelatin

Also known as: absorbable collagen hemostasis

Control arm label- Floseal®

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 19 years or older
• undergoing elective OPCAB surgery with multi-vessel coronary artery disease.

You may not qualify if:

• patients were pregnant
• had a known sensitivity to any components of the bovine thrombin preparations or the porcine origin materials.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, South Korea

Location

Related Publications (2)

• Lee H, Lee JH, Jeon CS, Ko JH, Park SN, Lee YT. Evaluation of a novel collagen hemostatic matrix in a porcine heart and cardiac vessel injury model. J Thorac Dis. 2019 Jul;11(7):2722-2729. doi: 10.21037/jtd.2019.06.59.

  PMID: 31463099 BACKGROUND

• Kim HH, Lee KJ, Kang DR, Lee JH, Youn YN. Hemostatic efficacy of a flowable collagen-thrombin matrix during coronary artery bypass grafting: a double-blind randomized controlled trial. J Cardiothorac Surg. 2023 Jun 15;18(1):193. doi: 10.1186/s13019-023-02196-3.

  PMID: 37322537 DERIVED

Related Links

• Collastat absorbable collagen hemostatic agent, which provides effective hemostasis for bleeding in high-pressure great vessel.

MeSH Terms

Conditions

Coronary Artery Disease; Hemorrhage

Interventions

Collagen

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Extracellular Matrix Proteins; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The agent was selected using the sealed envelope system. The selected agent was prepared immediately prior to use after randomization, and was delivered to the site of bleeding via a single-barrel syringe.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In cardiac surgery, patients were randomized to receive Floseal® or Collastat® (n=40), respectively. The selected agent was applied in the operating room.

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 17, 2020
• Study Start: February 5, 2018
• Primary Completion: March 17, 2020
• Study Completion: March 31, 2020
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)