Fibrinolysis Before Cardiopulmonary Bypass?

NCT01981863 | Completed Phase 4 Results

• 1 other identifier: Fibrinolysis
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

It is common practice to use antifibrinolytic agents before and during cardiopulmonary bypass. They are not without side effects. The investigators want to show that there is no proof of fibrinolysis in standard sternotomy cardiac surgery patients before cardiopulmonary bypass, and that antifibrinolytic agents should only be started on cardiopulmonary bypass.

Conditions

Pathologic Fibrinolysis

Keywords

cardiac surgery; cardiopulmonary bypass; fibrinolysis; thromboelastography; D-Dimers; antifibrinolytic agents

Outcome Measures

Primary Outcomes (1)

• Di-Dimer Increase Before Cardiopulmonary Bypass

  Change in Di-dimer between preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients.

  6 months

Secondary Outcomes (1)

• Value of Thromboelastography as Monitor of Fibrinolysis

  6 months

Other Outcomes (1)

• Length of Time Between Incision and Cardiopulmonary Bypass

  From incision to bypass, up to 3 hours

Study Arms (2)

Epsilonaminocaproic acid

EXPERIMENTAL

One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo

Drug: Epsilonaminocaproic acid

Placebo, Antifibrinolytic activity

PLACEBO COMPARATOR

Placebo: same IV volume as experimental arm

Drug: Placebo

Interventions

Epsilonaminocaproic acid DRUG

One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.

Also known as: Amicar

Epsilonaminocaproic acid

Placebo DRUG

Placebo administered in same volume as in experimental arm.

Placebo, Antifibrinolytic activity

Eligibility Criteria

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

You may qualify if:

• All adult patients, undergoing first time sternotomy for Coronary artery bypass grafting/Aortic valve replacement/aortic surgery

You may not qualify if:

• Resternotomy, renal insufficiency, deep hypothermia, age \< 18 yrs

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital & Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Interventions

Aminocaproic Acid

Intervention Hierarchy (Ancestors)

Aminocaproates; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Peter van der Starre
• Organization: Stanford University Medical Center

pieterva@stanford.edu

6507236412

Study Officials

• Pieter JA Van der Starre, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: November 13, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 30, 2016
• Results First Posted: June 30, 2016

Record last verified: 2016-04

Locations

US (1)