Protocol - Thrombosis - Venous - non-catheter-related

Personnel and Training Required

Personnel should be trained in medical record abstraction.

Equipment Needs

None

Requirements

Requirement Category	Required
Major equipment	No
Specialized training	No
Specialized requirements for biospecimen collection	No
Average time of greater than 15 minutes in an unaffected individual	No

Mode of Administration

Medical record abstraction

Lifestage

Infant, Toddler, Child, Adolescent, Adult, Senior, Pregnancy

Participants

Children and adults with sickle cell disease.

Selection Rationale

These questions from the Cure Sickle Cell Initiative (CureSCi) were constructed using a consensus process, are standard measures used in sickle cell disease gene therapy clinical trials and are straightforward to abstract from the medical record.

Language

English

Standards

Standard	Name	ID	Source

Derived Variables

None

Process and Review

Not Applicable

Protocol Name from Source

Cure Sickle Cell Initiative (CureSCi), F2909 Medical History Core Form, SCD Version 1.0

Source

Cure Sickle Cell Initiative (CureSCi), F2909 Medical History Core Form, SCD Version 1.0

General References

Ashorobi, D., Ameer, M.A., Fernandez, R., (2023). Thrombosis. [Updated 2023 Aug 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing. Available from: https://www.ncbi.nlm.nih.gov/books/NBK538430/

Naik, R. P., Streiff, M. B., Haywood, C., Jr, Nelson, J. A., & Lanzkron, S. (2013). Venous thromboembolism in adults with sickle cell disease: a serious and under-recognized complication. The American journal of medicine, 126(5), 443?449. https://doi.org/10.1016/j.amjmed.2012.12.016

Noubouossie, D., & Key, N. S. (2015). Sickle cell disease and venous thromboembolism in pregnancy and the puerperium. Thrombosis research, 135 Suppl 1, S46?S48. https://doi.org/10.1016/S0049-3848(15)50442-8

Protocol ID

890202

Variables

Export Variables

Variable Name	Variable ID	Variable Description	dbGaP Mapping
PX890202_Thrombosis_Venous_DVT_End
	PX890202020300	Does the participant/subject have a history more of the following medical problems/conditions? DVT End Date show less	N/A
PX890202_Thrombosis_Venous_DVT_Ongoing
	PX890202020200	Does the participant/subject have a history more of the following medical problems/conditions? DVT Ongoing show less	N/A
PX890202_Thrombosis_Venous_DVT_Start
	PX890202020100	Does the participant/subject have a history more of the following medical problems/conditions? DVT Start Date show less	N/A
PX890202_Thrombosis_Venous_Other_VTE_End
	PX890202040300	Does the participant/subject have a history more of the following medical problems/conditions? Other VTE End Date show less	N/A
PX890202_Thrombosis_Venous_Other_VTE_Ongoing
	PX890202040200	Does the participant/subject have a history more of the following medical problems/conditions? Other VTE Ongoing show less	N/A
PX890202_Thrombosis_Venous_Other_VTE_Start
	PX890202040100	Does the participant/subject have a history more of the following medical problems/conditions? Other VTE Start Date show less	N/A
PX890202_Thrombosis_Venous_Pulmonary Embolism_End
	PX890202030300	Does the participant/subject have a history more of the following medical problems/conditions? Pulmonary Embolism End Date show less	N/A
PX890202_Thrombosis_Venous_Pulmonary Embolism_Ongoing
	PX890202030200	Does the participant/subject have a history more of the following medical problems/conditions? Pulmonary Embolism Ongoing show less	N/A
PX890202_Thrombosis_Venous_Pulmonary Embolism_Start
	PX890202030100	Does the participant/subject have a history more of the following medical problems/conditions? Pulmonary Embolism Start Date show less	N/A
PX890202_Thrombosis_Venous_Specify_VTE_End
	PX890202050300	Does the participant/subject have a history more of the following medical problems/conditions? Specify VTE End Date show less	N/A
PX890202_Thrombosis_Venous_Specify_VTE_Name
	PX890202050400	Does the participant/subject have a history more of the following medical problems/conditions? Specify VTE show less	N/A
PX890202_Thrombosis_Venous_Specify_VTE_Ongoing
	PX890202050200	Does the participant/subject have a history more of the following medical problems/conditions? Specify VTE Ongoing show less	N/A
PX890202_Thrombosis_Venous_Specify_VTE_Start
	PX890202050100	Does the participant/subject have a history more of the following medical problems/conditions? Specify VTE Start Date show less	N/A
PX890202_Thrombosis_Venous_Thrombosis_End
	PX890202010300	Does the participant/subject have a history more of the following medical problems/conditions? Thrombosis End Date show less	N/A
PX890202_Thrombosis_Venous_Thrombosis_Ongoing
	PX890202010200	Does the participant/subject have a history more of the following medical problems/conditions? Thrombosis Ongoing show less	N/A
PX890202_Thrombosis_Venous_Thrombosis_Start
	PX890202010100	Does the participant/subject have a history more of the following medical problems/conditions? Thrombosis Start Date show less	N/A

SCD Pregnancy

Measure Name

Thrombosis

Release Date

August 5, 2024

Definition

Thrombosis is a blockage within a vessel (artery or vein), caused by a blood clot.

Purpose

Participants with certain inherited and acquired blood disorders, including sickle cell disease, have an overall increased risk of developing thrombosis. Additionally, certain acquired factors, such as pregnancy and central line placement, also increase the risk of thrombosis. 

Keywords

Thrombosis, blood clot, deep vein thrombosis (DVT), pulmonary embolism (PE), venous thromboembolism (VTE)

Measure Protocols

Protocol ID	Protocol Name
890201	Thrombosis - Catheter-related
890202	Thrombosis - Venous - non-catheter-related

Publications

There are no publications listed for this protocol.