Page last updated: 2024-11-02

oxybutynin and Blood Loss, Surgical

oxybutynin has been researched along with Blood Loss, Surgical in 1 studies

oxybutynin: RN given refers to parent cpd
oxybutynin : A racemate comprising equimolar amounts of (R)-oxybutynin and esoxybutynin. An antispasmodic used for the treatment of overactive bladder.

Blood Loss, Surgical: Loss of blood during a surgical procedure.

Research

Studies (1)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's1 (100.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Corral, M1
Ferko, N1
Hollmann, S1
Hogan, A1
Jamous, N1
Batiller, J1
Shen, J1

Clinical Trials (4)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Prospective, Randomized, Controlled, Superiority Evaluation of Fibrin Patch as an Adjunct to Control Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery[NCT00658723]Phase 2141 participants (Actual)Interventional2008-03-31Completed
A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Severe Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery[NCT00977925]Phase 391 participants (Actual)Interventional2009-08-31Completed
A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Elective Hepatic Surgery[NCT01166243]Phase 384 participants (Actual)Interventional2010-07-31Completed
A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST® Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery[NCT01993888]Phase 3102 participants (Actual)Interventional2013-10-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Incidence of Adverse Events

(NCT00658723)
Timeframe: 30 days (+14 days)

Intervention% if participants with atleast one AE (Number)
Fibrin Pad All94.6
SURGICEL™ Randomized90.0

Incidence of Adverse Events Potentially Related to Transfusion Exposure

The types of events that were potentially related to transfusion exposure could have include hypocalcemia. (NCT00658723)
Timeframe: Intra-operative up to 1 month (+14 days)

Interventionpercentage of particpants (Number)
Fibrin Pad - Randomized0
SURGICEL0
Fibrin Pad - Non-randomized0

Incidence of Adverse Events That Are Potentially Related to Bleeding

The types of events that were potentially related to bleeding included operative hemorrhage and re-bleeding of the target bleeding site (TBS). (NCT00658723)
Timeframe: Intra-operative up to 1 month (+14 days)

Interventionpercentage of particpants (Number)
Fibrin Pad - Randomized0
SURGICEL10
Fibrin Pad - Non-randomized0

Incidence of Adverse Events That Are Potentially Related to Thrombotic Events

The types of events that were potentially related to thrombotic events included deep vein thrombosis and pulmonary embolism (NCT00658723)
Timeframe: Intra-operative up to 1 month (+14 days)

Interventionpercentage of participants (Number)
Fibrin Pad - Randomized1.7
SURGICEL6.7
Fibrin Pad - Non-randomized13.7

Incidence of Treatment Failures

If hemostasis was not achieved within 4 minutes or if bleeding required additional intervention during the 6 minute observation period, the treatment was considered to be a failure. (NCT00658723)
Timeframe: Intra-operative

Interventionpercentage of treatment failure (Number)
Fibrin Pad - Randomized1.7
SURGICEL46.7
Fibrin Pad - Non-randomized2.0

Proportion of Subjects Achieving Hemostatic Success

Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period. (NCT00658723)
Timeframe: Intra-operative

Interventionpercentage of success (Number)
Fibrin Pad - Randomized98.3
SURGICEL53.3
Fibrin Pad - Non-Randomized98.0

Proportion of Subjects Achieving Hemostatic Success

The proportion of subjects achieving hemostatic success at 10 minutes following randomization (NCT00658723)
Timeframe: 10 minutes

Interventionpercentage of success (Number)
Fibrin Pad - Randomized98.3
SURGICEL73.3
Fibrin Pad - Non-randomized100.0

Incidence of Re-treatment

"The outcome measure assess if re-treatment was done after release of manual compression at 4-minutes for subjects not achieving hemostatic success or if re-treatment was done during the 6-minute observation period.~In the SURGICEL group, 18 subjects had initial hemostatic success at 4 minutes, but 2 of the 18 subjects were re-treated for re-bleeding. In the SURGICEL group, 12 subjects were not hemostatic at 4-minutes and had a re-treatment." (NCT00658723)
Timeframe: Intra-operative

,,
Interventionparticipants (Number)
Total Incidence of Re-treatmentNo hemostasis at 4-minutes and re-treatedAchieved hemostasis at 4-mins and re-treated
Fibrin Pad - Non-randomized110
Fibrin Pad - Randomized110
SURGICEL14122

Absolute Time to Hemostasis

The absolute time to achieve hemostasis at or after 4 minutes from randomization. (NCT01993888)
Timeframe: Intraoperative, an average of 4.2 minutes following randomization

Interventionminutes (Median)
EVARREST™ Fibrin Sealant Patch4.0
Standard of Care (SoC)4.7

Hemostasis at the Target Bleeding Site (TBS) at 10-minutes Following Randomization

Proportion of subjects achieving hemostatic success at 10 minutes following randomization and no further bleeding requiring treatment prior to initiation of wound closure. (NCT01993888)
Timeframe: Intraoperative, 10 minutes following randomization

Interventionparticipants with hemostatic success (Number)
EVARREST™ Fibrin Sealant Patch49
Standard of Care (SoC)42

Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization

Proportion of subjects achieving hemostasis at the TBS at 4-minutes following randomization and with no re-bleeding requiring treatment at the TBS any time prior to initiation of wound closure. Hemostasis is defined as no detectable bleeding at the TBS. (NCT01993888)
Timeframe: Intraoperative, 4 minutes following randomization

Interventionparticipants with hemostatic success (Number)
EVARREST™ Fibrin Sealant Patch48
Standard of Care (SoC)24

Incidence of Adverse Events That Were Potentially Related to Thrombotic Events

Number of participants with adverse events that were potentially related to thrombic events (NCT01993888)
Timeframe: Up to 60-days following surgery

Interventionparticipants (Number)
EVARREST™ Fibrin Sealant Patch2
Standard of Care (SoC)0

Incidence of Adverse Events (AEs)

(NCT01993888)
Timeframe: Up to 60-days following surgery

,
Interventionparticipants (Number)
Participants experienced at least one AEParticipants experienced at least one SAEParticipants experienced at least one Severe AE
EVARREST™ Fibrin Sealant Patch45128
Standard of Care (SoC)50166

Incidence of Re-bleeding Events From the TBS During the Study Follow-up

(NCT01993888)
Timeframe: Up to 60-days following surgery

,
Interventionparticipants (Number)
Continuous bleedingRe-bleedingDurability of hemostasisApplication error
EVARREST™ Fibrin Sealant Patch1010
Standard of Care (SoC)24311

Reviews

1 review available for oxybutynin and Blood Loss, Surgical

ArticleYear
Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials.
    Current medical research and opinion, 2016, Volume: 32, Issue:2

    Topics: Blood Loss, Surgical; Fibrin Tissue Adhesive; Hemostasis; Hemostatics; Humans; Randomized Controlled

2016
Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials.
    Current medical research and opinion, 2016, Volume: 32, Issue:2

    Topics: Blood Loss, Surgical; Fibrin Tissue Adhesive; Hemostasis; Hemostatics; Humans; Randomized Controlled

2016
Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials.
    Current medical research and opinion, 2016, Volume: 32, Issue:2

    Topics: Blood Loss, Surgical; Fibrin Tissue Adhesive; Hemostasis; Hemostatics; Humans; Randomized Controlled

2016
Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials.
    Current medical research and opinion, 2016, Volume: 32, Issue:2

    Topics: Blood Loss, Surgical; Fibrin Tissue Adhesive; Hemostasis; Hemostatics; Humans; Randomized Controlled

2016
Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials.
    Current medical research and opinion, 2016, Volume: 32, Issue:2

    Topics: Blood Loss, Surgical; Fibrin Tissue Adhesive; Hemostasis; Hemostatics; Humans; Randomized Controlled

2016
Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials.
    Current medical research and opinion, 2016, Volume: 32, Issue:2

    Topics: Blood Loss, Surgical; Fibrin Tissue Adhesive; Hemostasis; Hemostatics; Humans; Randomized Controlled

2016
Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials.
    Current medical research and opinion, 2016, Volume: 32, Issue:2

    Topics: Blood Loss, Surgical; Fibrin Tissue Adhesive; Hemostasis; Hemostatics; Humans; Randomized Controlled

2016
Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials.
    Current medical research and opinion, 2016, Volume: 32, Issue:2

    Topics: Blood Loss, Surgical; Fibrin Tissue Adhesive; Hemostasis; Hemostatics; Humans; Randomized Controlled

2016
Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials.
    Current medical research and opinion, 2016, Volume: 32, Issue:2

    Topics: Blood Loss, Surgical; Fibrin Tissue Adhesive; Hemostasis; Hemostatics; Humans; Randomized Controlled

2016
Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials.
    Current medical research and opinion, 2016, Volume: 32, Issue:2

    Topics: Blood Loss, Surgical; Fibrin Tissue Adhesive; Hemostasis; Hemostatics; Humans; Randomized Controlled

2016
Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials.
    Current medical research and opinion, 2016, Volume: 32, Issue:2

    Topics: Blood Loss, Surgical; Fibrin Tissue Adhesive; Hemostasis; Hemostatics; Humans; Randomized Controlled

2016
Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials.
    Current medical research and opinion, 2016, Volume: 32, Issue:2

    Topics: Blood Loss, Surgical; Fibrin Tissue Adhesive; Hemostasis; Hemostatics; Humans; Randomized Controlled

2016
Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials.
    Current medical research and opinion, 2016, Volume: 32, Issue:2

    Topics: Blood Loss, Surgical; Fibrin Tissue Adhesive; Hemostasis; Hemostatics; Humans; Randomized Controlled

2016
Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials.
    Current medical research and opinion, 2016, Volume: 32, Issue:2

    Topics: Blood Loss, Surgical; Fibrin Tissue Adhesive; Hemostasis; Hemostatics; Humans; Randomized Controlled

2016
Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials.
    Current medical research and opinion, 2016, Volume: 32, Issue:2

    Topics: Blood Loss, Surgical; Fibrin Tissue Adhesive; Hemostasis; Hemostatics; Humans; Randomized Controlled

2016
Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials.
    Current medical research and opinion, 2016, Volume: 32, Issue:2

    Topics: Blood Loss, Surgical; Fibrin Tissue Adhesive; Hemostasis; Hemostatics; Humans; Randomized Controlled

2016