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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04310150
Recruitment Status : Completed
First Posted : March 17, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
In this prospective open-label randomized trial, 80 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=40), 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Collastat Device: Floseal Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In cardiac surgery, patients were randomized to receive Floseal® or Collastat® (n=40), respectively. The selected agent was applied in the operating room.
Masking: Single (Participant)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Collagen-thrombin Matrix Efficacy During Cardiac Surgery: a Prospective Randomized Controlled Trial
Actual Study Start Date : February 5, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment arm label- Collastat® Drug: Collastat
hemostatic agent that combine porcine-derived collagen thrombin
Other Name: absorbable collagen hemostasis

Active Comparator: Control arm label- Floseal®
an marketed product is Floseal
Device: Floseal
hemostatic agent that combine bovine-derived gelatin
Other Name: absorbable collagen hemostasis




Primary Outcome Measures :
  1. the proportion of patients with complete hemostasis [ Time Frame: Participants will be followed for the time required for hemostasis, an expected average of 3 minutes. ]
    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®


Secondary Outcome Measures :
  1. blood loss in the operative day [ Time Frame: 24 hours later after surgery ]
  2. amount of blood products transfused both intraoperatively and postoperatively [ Time Frame: 24 hours later after surgery ]
  3. rate of surgical revision for bleeding [ Time Frame: 5 minutes later after anastomosis ]
  4. total length of intensive care unit (ICU) stay [ Time Frame: mean 3-4 days after surgery ]
  5. rate of postoperative morbidity/mortality [ Time Frame: Participants will be followed during 1 years from operation ]


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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04310150


Locations
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Korea, Republic of
Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
Additional Information:
Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT04310150    
Other Study ID Numbers: 1-2017-0094
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
Bleeding
Blood transfusion
Coronary artery bypass surgery
Hemostasis
Topical therapy
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hemostatics
Coagulants