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Completed

NCT Number: NCT02640235

Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding

The study is to evaluate the effectiveness and safety of CELSTAT vs active control.

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Key information

Conditions

Bleeding Active

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Kralovske Vinohrady, Clinic of Surgery, Prague, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Preoperative

  • Subject is undergoing planned cardiothoracic, general or vascular surgery

Intraoperative

  • Mild or moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after standard conventional surgical hemostatic methods prove to be ineffective or impractical.

Exclusion criteria

Preoperative

  • Subject needs emergency surgery
  • Subject will undergo renal transplantation, or minimally invasive/laparoscopic surgery
  • Subject will undergo neurological or ophthalmological surgery
  • Subject will undergo urological or gynecological surgery
  • Subject has congenital coagulation disorder
  • Subject is pregnant or lactating at the time of enrollment, or becomes pregnant prior to the planned surgery

Intraoperative:

  • Occurrence of any surgical complication that requires resuscitation or deviation from the planned surgical procedure prior to identification of target bleeding site
  • Disseminated intravascular coagulopathy

Treatment and study plan

CELSTAT

Device

Surgicel Original

Device

Primary outcomes

  1. Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application

    Time frame: 5 minute (post-application)

    Hemostasis is a process to prevent and stop bleeding within damaged blood vessels. Once the product(s) is applied it absorbs blood, turns brown, and adheres to the wound, thereby preventing thrombocytes from being washed out and accelerating hemostasis. Target bleeding sites include mild to moderate parenchymal (organ tissue),vascular (small arteries or veins or surgical reconnections) and soft tissue (muscle, fat, ligament, connective tissue) bleeding.

  2. Number of Participants With Post-operative Re-bleeding at Target Bleeding Site Requiring Surgical Re-exploration

    Time frame: Day 1 to Day 91

    Findings are reported in this outcome measure and would have also been reported as an AE.

Secondary outcomes

  1. Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants

    Time frame: 0 to 10 minutes (post-application)

    Data presented is an interpretation of a Kaplan-Meier plot based on quartiles of the survival distribution estimate. "Survival" times need not relate to actual survival with death being the event; the "event" may be any event of interest. The Kaplan-Meier curves and estimates of survival data have become a familiar way of dealing with differing survival times (times-to-event).

  2. Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application

    Time frame: 3 minutes (post application)

    The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.

  3. Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application

    Time frame: 7 minutes (post application)

    The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.

  4. Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application

    Time frame: 10 minutes (post application)

    The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.

  5. Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis

    Time frame: 0 to 10 minutes (post-application)

    If intraoperative re-bleeding occurred, the primary endpoint was considered "treatment failure."

  6. Number of Occurrences of Treatment Emergent Adverse Events (Serious and Non-Serious)

    Time frame: Day 1 to Day 91

    Adverse Events (AEs) that occurred after the start of study treatment application are referred to as "treatment-emergent AEs" (TEAE). Timeframe for tracking AE's up to Day 91 (minus/plus 10 days=from Day 81 to Day 101).

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Registry information

Official study title

A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness and Safety of CELSTAT as an Adjunct to Hemostasis for Tissue Bleeding in Cardiothoracic, General, and Vascular Surgery.

Acronym: CELSTAT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 28, 2015
Registry last updated
Aug 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.