Cardiac Surgery: In Vivo Titration of Protamine

NCT00684450 | Completed DMC

• 1 other identifier: ICM 07-997
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

Safe use of cardiopulmonary bypass (CPB) requires massive doses of intravenous unfractionated heparin. At end-CPB, residual heparin is neutralized with intravenous injection of protamine sulfate. This prospective, randomized, controlled study will be conducted in 82 voluntary subjects admitted for elective, first intention, cardiac surgery requiring cardiopulmonary bypass. Each will be randomly assigned to one of two groups. The control group will be submitted to a standard protamine infusion of 1.3mg :100U of the total heparin dose given during bypass. The test group will receive an infusion of protamine (over 15 minutes) until activated clotting time (ACT) values (determined every 3 minutes) depict a plateau, sign that the optimal protamine to heparin ratio has been attained. The investigators hypothesize this new in vivo titration method to be as efficient as the standard protocol (adequacy of heparin neutralization, % heparin rebound, bleeding, and transfusion), and potentially safer by its ability to prevent protamine overdose and its deleterious impact on platelet function.15 Principal Objective Evaluate a new in vivo method of titration of protamine sulfate. Secondary Objective Evaluate the impact of this method on the adequacy of heparin neutralization by measuring:

1. 1.platelet count
2. 2.postoperative bleeding
3. 3.transfusion exposure a
4. 4.incidence of heparin rebound

Conditions

Bleeding

Keywords

titration of protamine; exact dose; protamine; neutralize heparin

Outcome Measures

Primary Outcomes (1)

• Effective heparin neutralization (anti-Xa < 0.3 U/ml)

  Pre protamine, 15 min post protamine, 3h post protamine

Secondary Outcomes (3)

• Frequency of heparin rebound

  15 min post protamine and 3 hours post Protamine

• Blood losses after surgery and transfusion requirements

  discharge

• Preservation of the platelet count

  Pre operate, Pré Protamine, 15 min post Protamine, 3 hours post Protamine

Study Arms (2)

1

ACTIVE COMPARATOR

in vivo protamine titration in cardiac surgery. The titration is done during administration of protamine each 3 minutes to reach 2 consecutive ACT defined as 2 similar ACT values, within 10% variability, and ACT ≤ to 160 seconds. .The protamine is stopped when this values are obtain. Follow-up is done 15 minutes and 3 hours post-protamine

Procedure: Titration protamine

2

ACTIVE COMPARATOR

standard protamine administration ACT is done during administration of protamine each 3 minutes the values are recorded but the totality of protamine is given. Follow-up is done 15 minutes and 3 hours post-protamine

Drug: Standard administration of protamine

Interventions

Titration protamine PROCEDURE

10\. Study group: celite ACT will be performed every 3 minutes during protamine infusion until ACT values suggest reach of a plateau (defined as 2 similar ACT values, within 10% variability, and ACT ≤ to 160 seconds.), time at which infusion will be stopped. 2cc of blood is required per ACT test, for a maximum total of 10cc.

Also known as: Protamine in vivo titration in cardiac surgery

1

Standard administration of protamine DRUG

1.3 mg of Protamine for 100u héparine

2

Eligibility Criteria

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

You may qualify if:

• First intention, elective, cardiac surgery: either Coronary Artery Bypass Graft (CABG)or valve repair/replacement.
• Patients on preoperative aspirin, clopidogrel or heparin will be included.

You may not qualify if:

• Combination of CABG and valve surgery
• Second intention cardiac surgery
• ASA 5 patients
• Pre-existing hemostatic disorder (as evidenced by history)
• Pregnancy
• PLavix \< 5 days before de surgery

Sponsors & Collaborators

• Montreal Heart Institute: lead
• Organon: collaborator

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (30)

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MeSH Terms

Conditions

Hemorrhage

Interventions

Protamines; Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nuclear Proteins; Proteins; Amino Acids, Peptides, and Proteins; Nucleoproteins; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Antoine G Rochon

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. FRCPC

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 26, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 25, 2011

Record last verified: 2011-08

Locations

CA (1)