Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00824564

First received: January 14, 2009

Last updated: June 6, 2011

Last verified: June 2011

History of Changes

Results First Received: June 6, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Femoral Fractures
Interventions:	Drug: Tranexamic Acid plus standard of care Procedure: Standard of care

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Tranexamic Acid Plus Standard of Care	Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
Standard of Care	Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.

Participant Flow: Overall Study

	Tranexamic Acid Plus Standard of Care	Standard of Care
STARTED	42	40
Treated	41	40
COMPLETED	34	30
NOT COMPLETED	8	10
Lost to Follow-up	5	7
Withdrawal by Subject	1	1
Unspecified	1	2
Randomized, but not treated	1	0

Baseline Characteristics

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Reporting Groups

	Description
Tranexamic Acid Plus Standard of Care	Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
Standard of Care	Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
Total	Total of all reporting groups

Baseline Measures

	Tranexamic Acid Plus Standard of Care	Standard of Care	Total
Number of Participants [units: participants]	41	40	81
Age [units: Years] Mean ± Standard Deviation	33.7 ± 12.6	36.6 ± 17.0	35.1 ± 14.9
Gender [units: Participants]
Female	5	7	12
Male	36	33	69

Outcome Measures

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1. Primary:

Total Blood Loss [ Time Frame: Baseline through Day 7 post-surgery ]

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2. Secondary:

Intra-operative Blood Loss [ Time Frame: Day 1 (End of surgery) ]

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3. Secondary:

Post-operative Blood Loss [ Time Frame: 1, 4, 8 and 24 hours post-surgery ]

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4. Secondary:

Total Blood Loss Assessed by Gross’ Formula [ Time Frame: Day 7 post-surgery ]

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5. Secondary:

Number of Participants Receiving Transfusions [ Time Frame: Up to day 7 post-surgery ]

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6. Secondary:

Change From Baseline in Hemoglobin Levels at End of Surgery, 1 hr Post-surgery, and Mornings of Day 1, Day 2, Day 4, Day 7 or Early Termination (ET) Post-surgery [ Time Frame: Baseline through end of surgery, 1 hr post-surgery, and mornings of Day 1, Day 2, Day 4, Day 7 or ET post-surgery ]

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7. Secondary:

Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery [ Time Frame: Day 5 post-surgery ]

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Serious Adverse Events

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Time Frame	No text entered.
Additional Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Reporting Groups

	Description
Tranexamic Acid Plus Standard of Care	Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
Standard of Care	Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.

Serious Adverse Events

	Tranexamic Acid Plus Standard of Care	Standard of Care
Total, serious adverse events
# participants affected / at risk	4/41 (9.76%)	1/40 (2.50%)
Cardiac disorders
Cardiac failure ^{* 1}
# participants affected / at risk	0/41 (0.00%)	1/40 (2.50%)
Injury, poisoning and procedural complications
Fat embolism ^{* 1}
# participants affected / at risk	1/41 (2.44%)	0/40 (0.00%)
Vascular disorders
Deep vein thrombosis ^{* 1}
# participants affected / at risk	3/41 (7.32%)	0/40 (0.00%)

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA 13.0

Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The data for hemoglobin levels was planned but not evaluated on the morning of Day 7 post-surgery.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00824564 History of Changes
Other Study ID Numbers:	B1461002
Study First Received:	January 14, 2009
Results First Received:	June 6, 2011
Last Updated:	June 6, 2011
Health Authority:	India: Institutional Review Board

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